Gormley NPI Consulting

By James J. Gormley
With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petitions in 10 days calling for Congress to withhold FDA appropriations until this unaccountable agency is held to account: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary supplements.

To help us in this effort, Australian truth rapper and activist Jody Lloyd, aka Trillion, has re-mastered CFH’s “10,000 Signatures” video to make our call-to-arms that much more impactful!
Please sign the petition today and send out the link (and video!) to all of your contacts, friends and family, work colleagues, in short, everyone in your personal universe who cares about their rights to high-quality, innovative dietary supplements!

Petition to Demand that the FDA Withdraws the NDI Draft Guidance!

2011-11-18T22:22:00.000-08:00

By James J. Gormley

Let's call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

That's why we created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:

"I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA."

Will you sign this petition? Please click here.

Thanks!

A Defining Moment for the Dietary Supplement Industry

2011-11-11T22:20:00.000-08:00

By James J. Gormley
The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”

Although this same notice observes that the Guidance is not binding, the U.S. Food and Drug Administration’s (FDA) new dietary supplements’ director and erstwhile industry representative, Daniel Fabricant, PhD, made it clear that the FDA believes that the guidance contains “no surprises” (It, in fact, contains many) and merely provides “clarity” (Yes and no: it makes it clear that the FDA is willfully re-interpreting DSHEA is several key areas but is fuzzy on specifics).

And while Dr. Fabricant and his new employer may persist in believing that the Guidance contains no rabbits pulled out of a proverbial hat, a chief architect and co-author of DSHEA, Sen. Orrin Hatch (R-Utah), is alarmed by the Guidance.

Recently, at least one industry opinion leader has suggested that playing nice with the FDA on the Guidance would be the way out of the NDI quagmire since the FDA supposedly has such a stellar track record of working collaboratively with industry.

Nothing could be further from the truth. Every major victory won by the natural products industry has been always bloody, sometimes ugly and never cordial.

War seldom is.

In 1966, the FDA announced plans that it was going to ban nutrient potencies over the RDAs by reclassifying them as drugs, along with labeling restrictions that would have forbidden the inclusion of any useful information about supplements.

When this, the health-food industry’s, first defining conflict was waged in the late 1960s and 1970s, the battle cry that the great, and recently departed, Max Huberman rallied the industry and consumers around was, “No surrender! No retreat!”

The battle cry was not “Let’s play nice,” of that I can assure you.

In the early 1990s, when the industry and consumers were fed up with FDA raids on health-food stores and efforts by the agency to use food additive provisions of existing law to go after supplements and companies for which the agency bore a deep-seated animus, a dramatic response was needed, and aggressive, coordinated grassroots action was with what consumers and the industry fought back: black, funereal fabric was used to cover dietary supplements in health food stores, a major public service announcement was aired and millions of Americans demanded the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

And we won.

Offering an olive branch to the FDA at the time would have led to the destruction or gutting of the dietary supplements industry before many of us were even a part of it.

So for our industry to offer concessions on the Guidance while the battle has just begun is diametrically opposed to what the greatest debaters have known since the time of Cicero: being unattached to the outcome.Master negotiator Herb Cohen said this often: “I care, I really do … but not that much.”

Modern-day Cicero, Jeff Schneider explains this to mean that whichever party has the greater need to get the deal done is the party that is at a competitive disadvantage. He says that the moment we start making concessions prematurely is the moment we lose our leverage.

“It is unwise to assume that the person [or Agency] you are negotiating with maintains the same commitment to Win-Win outcomes that you have,” writes Schneider. He advises negotiators to “establish your line in the sand. […] You must vow not to cross the established line in the sand for any reason.”

Do those industry experts and pundits applauding accomodationist approaches to the NDI Draft Guidance know that the FDA is not our industry’s friend, and that the agency bears an institutional resentment (some might say hatred) against our marketplace and its products and has shown this since the 1960s with raids, illegal wiretaps, improper seizures and a boatload of adversarial rulings and decisions?

Do those self-appointed savants know that the legal duty of any agency is to solely regulate and enforce according to the law given to it by the American people through Congress, and agencies do not have the power to devise policy and are not allowed to issue regulations or enforce one millimeter outside of the express letter of the law?

They should.

When any agency, in this case the FDA, violates the law by re-interpreting the plain and intended letter and meaning of it, in this case DSHEA, it must be called on it.

We must not stand for side-door efforts to cripple or maim our industry, and we have no obligation to give one inch on this, especially when dealing with an out-of-control agency that is, through stated intent, itself violating the law with which it was entrusted by the American people to uphold.

For those who have not yet taken action on the issue, there are only about 20 days left to so, given the current deadline of December 2nd. Please write to Congress here and to FDA Dockets here and circulate these links via all of your lists!

Let no one in our industry fall victim to the romance of “having a seat at the table” as a representative of the regulated industry.

Because that plate in front of them might well be empty.

IFT Interview With Dr. Philip Nelson

2011-10-21T16:16:00.000-07:00

Natural Products Foundation – John R. Carlson Memorial

2011-10-08T07:35:00.000-07:00

Natural Products Foundation – John R. Carlson Memorial

Citizens for Health: NDI guidance ‘contravenes spirit and letter of DSHEA'

2011-09-24T10:33:00.000-07:00

Citizens for Health: NDI guidance ‘contravenes spirit and letter of DSHEA'

Citizens for Health Launches Campaign Against FDA’s NDI Guidance

2011-09-21T13:11:00.000-07:00

Citizens for Health Launches Campaign Against FDA’s NDI Guidance

Jarrow Formulas Challenges FDA on NDIs With 128-Item Freedom of Information Request

2011-09-16T09:57:00.000-07:00

By Stephen Daniells

From Nutraingredients-USA.

California-based Jarrow Formulas has submitted a 128-item Freedom of Information [Act] Request to the U.S. FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.

The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.

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Norman R. Farnsworth, Renowned Medicinal Plant Researcher, Dies at 81

2011-09-12T09:08:00.000-07:00

From American Botanical Council

Renowned pharmacognosist and internationally-respected medicinal plant research expert, Norman R. Farnsworth, PhD, died on September 10 at a Chicago hospital. He was 81 and had been in declining health for months, suffering from long-term congestive heart failure and type 2 diabetes.

Dr. Farnsworth was born on March 23, 1930 in Massachusetts. Norman Farnsworth was a veteran of the Korean War, drafted in the US Army at age 18 in 1949. PFC Farnsworth served in the Third Infantry Division, Seventh Regimental Combat Team. Although he was seriously wounded in the winter of 1950, Farnsworth survived. Corporal Farnsworth was awarded the Korean Ribbon with Four Battle Stars, the Combat Medical Badge, and Bronze Star with a "V" device.

He received his degree in pharmacy from the Massachusetts College of Pharmacy in 1953 and his PhD in pharmacognosy, the study of drugs from natural origins (including medicinal plants, microbes, marine organisms, and fungi), from the University of Pittsburgh in 1959. At Pitt, he helped to institute a pharmacognosy PhD program at the university and was the first to chair it.
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FDA Extends NDI Draft Guidance Comment Period by 60 Days

2011-09-08T13:01:00.000-07:00

Adapted from Natural Products INSIDER

FDA extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA to extend the comment period by 45 days.

NPA, along with the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) , the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) requested a 45-day extension for comments, asking for a deadline of Nov. 17, 2011.

Last week, Jarrow Formulas, a dietary supplement company, requested FDA extend the comment period by one year; however, FDA chose to extend the comment period by an additional two months.

The original 90-day deadline for comments regarding FDA’s “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was Oct. 3, 2011.
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Trade Associations: 45-Day NDI Draft Guidance Extension Request Reasonable

2011-09-07T13:26:00.000-07:00

From Nutraingredients-USA

By Stephen Daniells

Spokespeople from the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) were responding to requests from other quarters of the industry to extend the comment period from 90 days to one year.

Last week, supplement manufacturer Jarrow Formulas added its voice to those of an initial request on July 26, 2011 by law firm Hyman, Phelps and McNamara, P.C. to extend the comment [period] until July 5, 2012.
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FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

2011-09-05T19:23:00.000-07:00

FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

What’s old is new again? The FDA takes aim at modern science and innovation

2011-09-05T19:18:00.000-07:00

What’s old is new again? The FDA takes aim at modern science and innovation

Quality: Giving It A Chance

2011-09-05T19:17:00.000-07:00

Quality: Giving It A Chance

Capitol Comments: Dissecting FDA’s NDI Guidance

2011-09-01T12:56:00.000-07:00

From Nutraceuticals World

By Todd Harrison

On July 1, 2011, FDA published its long-awaited Draft Guidance on New Dietary Ingredient (NDI) Notifications. The notice of availability of the Draft Guidance was published in the Federal Register on July 5, 2011. While comments on the guidance may be submitted to the agency at any time, to ensure consideration by the agency, comments should be submitted by October 2, 2011.

First and foremost, the positions articulated by FDA in the Draft Guidance can be expected to have a significant impact on all those who manufacture or distribute dietary supplement products. As such, the Draft Guidance must be evaluated very carefully to determine the effects it may have on your company.
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Associations Oppose Supplement Labeling Bill

2011-09-01T12:10:00.000-07:00

From Nutraceuticals World

The Natural Products Association (NPA), Washington, D.C., has launched a grassroots campaign to oppose the “Dietary Supplement Labeling Act” recently introduced in Congress by Senator Richard Durbin (D-IL). NPA is urging its more than 1900 members to ask their legislators to oppose the bill by sending them a letter. Among other provisions, the bill would direct the Department of Health and Human Services (and presumably FDA) to create a list of ingredients and proprietary blends of ingredients that “could cause potentially serious adverse events.” According to NPA, this overly broad language (e.g., no definition is offered of “could cause”) takes the regulation of supplements well beyond the current, effective rules governing the industry.
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Jarrow Formulas Calls for 1-Year NDI Draft Comment Extension

2011-09-01T12:00:00.000-07:00

From NutraIngredients-USA

By Stephen Daniells

California's Jarrow Formulas has called for an extension of the comment period on the FDA's NDI draft guidance to one year. Citing the scope of the draft guidance, its complexity, and its potential impact, a letter on behalf of Jarrow Formulas Inc. (JFI) said that the current 90-day comment period is insufficient, and that it is "respectfully requesting" an extensio to July 5, 2012.
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Rising Up Against Durbin’s Bill

2011-07-07T12:05:00.000-07:00

From Natural Products INSIDER

By Steve Myers

Once again, the Natural Products Association (NPA) is seeding a grassroots campaign to fight Congressional opposition to the dietary supplement industry and DSHEA. In the wake of Illinois Sen. Dick Durbin’s latest bill, this one proposing mandatory dietary supplement company registration and an FDA/IOM-compiled list of potentially dangerous ingredients, NPA is urging its 1,900-plus members to send letters to their legislators asking them to oppose Durbin’s bill, the Dietary Supplement Labeling Act.

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On-Trend Products Defying Economic Downturn

2011-07-01T11:37:00.000-07:00

From Nutraceuticals World

According to Netherlands-based Innova Market Insights, new food products with an ethical or premium positioning are on the rise despite the difficult economic situation. New data show that consumers, while pinching pennies elsewhere, are readily snatching up value-added products positioned on ethical platforms.

As a percentage of total U.S. launches, new food products with an ethical positioning grew from more than 3% in 2008 to 6% of introductions tracked in the first quarter of 2011. This paradigm shift comes as the wellness category is blurring to encompass new areas not typically considered as health and nutrition, such as “minimally processed,” “locally sourced” and “sustainable” and appealing to a more “responsible” American consumer increasingly concerned about the environment and sustainability.
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Packaged Facts Reveals Food, Beverage & Snack Insights

2011-07-01T11:31:00.000-07:00

From Natural Products INSIDER

Far outpacing growth in conventional groceries, U.S. retail sales of natural and organic foods and beverages rose to nearly $39 billion in 2010, an increase of 9% over the previous year, and 63% higher than sales five years earlier, according to “Natural and Organic Foods and Beverages in the U.S., 3rd Edition” by market research publisher Packaged Facts.

The next several years are forecast to experience even greater growth. Packaged Facts projects 2011 will serve as a jump-start for the market as sales ultimately increase by a dramatic 45% by the end of the year. Overall projections are that the market will grow by 103% between 2010 and 2015, with total annual sales exceeding $78 billion in 2015.
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Negative EU Claims List Won’t Come Before Summer 2012

2011-07-01T11:16:00.000-07:00

From Nutraceuticals World

The threat of an EU-wide ban on the use of article 13.1 claims on the European Commission’s negative register is not expected before next summer, according to international food policy consultancy EAS. Stefanie Geiser, EAS regulatory affairs manager, said as the European Commission has indicated it intends to present its proposal for an article 13.1 “Union list” of claims to the Standing Committee for discussion and potential adoption only by the end of 2011, it was unlikely that any ban on rejected claims would come into force before spring or summer 2012.
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NOW International Earns IL Export Award

2011-06-30T11:54:00.000-07:00

From Natural Products INSIDER

Illinois Governor Pat Quinn presented NOW International with the Governor’s Export Award for Continuing Excellence in Exporting in the large company (more than 500 employees) category. NOW Foods president Al Powers said the award recognizes NOW’s teamwork and its mission to help people live healthier lives with natural products.

The award recognizes businesses that exemplify significant contributions to Illinois’ economic development in the fields of export and manufacturing, service and agribusiness. This was the second time the State of Illinois honored NOW International’s track record of growing exports; the company received a similar award for 2008. The company has also been recognized twice with the U.S. President’s “E" Award for Achievement in Export.
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New Durbin Bill Would Change DSHEA

2011-06-29T12:02:00.000-07:00

From Natural Products INSIDER

A new bill from longtime DSHEA critic Sen. Dick Durbin (D-Ill.) would change the way supplements are regulated in very significant ways and add a lot of new burdens and costs to the industry. All supplement companies would be required to register every product with FDA, including ingredient lists and a copy of the label. There would also be required warning labels on certain ingredients as determined by FDA and the Institute of Medicine (IOM). Also, all products with "proprietary blends" would have to disclose the amount of each specific ingredient in the blend (so basically, no more proprietary blends). There is more, and it is not good. Needless to say, this is a bad bill for industry and consumers.

New Durbin Bill Goes After Supplements

2011-06-28T11:26:00.000-07:00

From Natural Products INSIDER

Sen. Dick Durbin (D-Ill.) is again going after what he perceives to be weakly regulated dietary supplements by introducing a new bill this week that would require all supplements to be registered with FDA along with their labels and ingredients, require new cautions on labels, and require FDA to define what is a conventional food and what is a dietary supplement. The bill is called the Dietary Supplement Labeling Act.

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FDA’s New Take on Imports

2011-06-20T11:19:00.000-07:00

From Natural Products INSIDER

FDA is stepping up enforcement on imported foods, supplements and ingredients with a new strategy designed to meet the regulatory challenges posed by the increased number of products imported to the United States. A report released by FDA, titled "Pathway to Global Product Safety and Quality," calls for coalitions of and increased data sharing among international regulators.

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Dietary Supplement Industry and the Park Doctrine

2011-06-13T07:51:00.000-07:00

From Natural Products INSIDER

By Nadia A. Karim

The Park Doctrine, as decided by the U.S. Supreme Court in United States v. Park, could be a potential threat to the dietary supplement industry. Under Park, companies can be criminally sanctioned for non-compliance with cGMPs (current good manufacturing practices).

Firms already struggling with qualitative and quantitative testing (e.g., pre- and post- production), quality control (QC), validation and documentation stand to face potential criminal consequences irrespective of whether there was intent to disregard cGMP.

If a dietary supplement firm is struggling with compliance related to the necessary testing requirements, it naturally follows that the firm likely will not be able to provide proof that a product is safe for human consumption as required by the new rules.
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SIDI Working Group Comments on FSMA

2011-06-01T07:46:00.000-07:00

From Nutraceuticals World

The Standardized Information on Dietary Ingredients (SIDI) Working Group, composed of dietary supplement firms and industry trade associations, recently submitted comments to FDA regarding the Food Safety Modernization Act (FSMA): “Title III—A New Paradigm for Importers.” SIDI supports establishing a strong program for qualifying raw material suppliers, testing incoming ingredients and verifying the contents of finished products in order to reduce the risks of contamination, adulteration and other supply chain failures.

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Nutrition 21’s Chromium Histidinate Protects Brain

2011-04-26T07:39:00.000-07:00

From Natural Products INSIDER

Chromium histidinate, from Nutrition 21 Inc., helped to protect the brain from damage caused by hypoglycemia (low blood sugar) induced by a high dose of insulin, according to a study presented at the Federation of American Societies for Experimental Biology (FASEB) annual meeting in Washington.

Researchers at Firat University tested the ability of chromium histidinate to protect the brain against hypoglycemia caused by a high dose of injected insulin. They found that rats fed chromium histidinate prior to the insulin injection had significantly less insulin-induced brain damage compared to the untreated control group.
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FDA New Dietary Ingredient Guidance Leaked

2011-04-01T07:33:00.000-07:00

From The Benninger Blog

A copy of the FDA's much anticipated guidance on New Dietary Ingredients has made its way out of the agency and some of its contents are raising eyebrows. The agency had been given a deadline of 180 days after the Food Safety Modernization Act (FMSA) became law to release the document.

The first 307 pages of the 308 page document focus on interpreting the meaning of the word "new." The agency refers frequently to Webster's Ninth New Collegiate Dictionary published in 1986, for example citing the second definition of "new" from page 796 of the reference book: "new: having been seen, known or used for a short time"

The agency then refers to the Webster definition of "time", specifically definition b: "a continuum which lacks spatial dimensions and in which events succeed one another from past through present to future."

After the 300+ pages of footnoted justification, the document concludes by stating that "based on the agency's determination that all ingredients have been seen, known or used for a short continuum lacking spatial dimensions, the agency concludes that by definition all ingredients are New Dietary Ingredients, and therefore 99.99999% of products currently on the market are adulterated."

April Fools.

More Regulation on the Way For Global Supplement Market

2011-03-01T07:22:00.000-08:00

From Natural Products INSIDER

Growing market sizes, heightened attention to product safety and the continuing harmonization of food supplement regulations show a global trend toward more regulation, according to the International Alliance of Dietary/Food Supplement Associations (IADSA). While food supplement harmonization is already underway in the European Union, decisions are expected this year on key aspects of the Association of South East Asian Nations’ (ASEAN) similar harmonization process toward a regional legislation.

“Many countries are in the process of developing new regulatory frameworks, and regulators are increasingly monitoring the successes and challenges of similar initiatives across the globe,” said Peter Zambetti, IADSA chairman.

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Daniel Fabricant Moves From NPA to FDA

2011-02-02T07:16:00.000-08:00

From Natural Products INSIDER

Daniel Fabricant, Ph.D., resigned as vice president of Global Government and Scientific Affairs for the Natural Products Association (NPA) after five years to enter government service as FDA’s director of its Division of Dietary Supplement Programs. Fabricant will start his new position at the end of February.

Fabricant will transition his responsibilities to Cara Welch, Ph.D., and Liz Hurst who will continue to manage and oversee NPA's collective scientific, regulatory and government affairs portfolio.
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NOW Foods Develops Screening Method Against Adulteration

2011-01-20T07:12:00.000-08:00

From Nutraceuticals World

Scientists at NOW Foods, Bloomingdale, IL, have developed a method for screening dietary supplement ingredients for adulteration, addressing an increasingly problematic practice by fringe companies. A scientific report describing the method has been accepted for publication in the peer-reviewed journal, Vibrational Spectroscopy. The method requires only thirty seconds grinding in an analytical mill before performing the scan. Including milling the samples, the entire screening process can be performed in less than 10 minutes per sample.

Can FDA Afford to Implement New Food Safety Measures?

2011-01-03T07:05:00.000-08:00

From Natural Products INSIDER

By Steve Myers

The passage of an ambitious new food safety act (Food Safety Modernization Act) presents a new challenge to an old problem at FDA: will the agency receive the funding it needs to implement the new system and effectively undertake its new enforcement activities?

In a press teleconference today, FDA Chief Peggy Hamburg said some of the mandated activities the bill requires of FDA were previously set in motion by the agency, so they will be theoretically introduced more quickly and efficiently. However, a Congressional Budget Office (CBO) estimated the cost of the new food safety system at around $1.4 billion over five years. Hamburg, who said Congress has basically told FDA to build a new system for monitoring and enforcing food safety, was not terribly forthcoming about her agency’s expectations for receiving the funding needed to meet this cost.
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Nutrition 21 to Enter Cough/Cold Market

2010-12-01T06:48:00.000-08:00

From Nutraceuticals World

Expanding its product portfolio, Nutrition 21, Inc., Purchase, NY, has received an exclusive license in the U.S. from Denmark-based Provita Development ApS for Coldizin, an ingredient combination patented in the U.S. and Europe for enhancing upper-respiratory health. A patent is pending in Canada. The exclusive license allows Nutrition 21 to expand its product portfolio with a novel, clinically substantiated ingredient for the $4.5 billion U.S. cough and cold category.
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NDIs, Adulteration on AHPA’s Radar

2010-11-15T07:00:00.000-08:00

From Natural Products INSIDER

While notification to FDA of new dietary ingredients (NDIs) has been a requirement since the passage of the Dietary Supplement Health & Education Act (DSHEA), many companies continue to struggle to understand the process. Virgo Publishing’s Jon Benninger spoke with Michael McGuffin, president of the American Herbal Products Association (AHPA), during SupplySide West in October 2010 regarding NDIs and other hot industry issues, after McGuffin spoke on a panel about NDIs.

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Nutrition 21 Awarded Grant for Diabetic Technology

2010-11-09T06:54:00.000-08:00

From Natural Products INSIDER

Nutrition 21 Inc., the developer and marketer of clinically substantiated ingredients for dietary supplements, foods and beverages, and animal nutrition, announced the award of a cash grant of up to $104,350 from the Federal Qualifying Therapeutic Discovery Project (QTDP) Program to help further develop its patent pending chromium-enhanced insulin technology for use in the treatment of type 1 and type 2 diabetes.

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Election Brings Potential Threats to Natural Product Industry

2010-11-03T06:42:00.000-07:00

From Natural Products INSIDER

John Gay from the Natural Products Association (NPA) called yesterday’s mid-terms “the most remarkable election in my 25 years in Washington," and the natural product industry advocacy group said it will stay abreast of potential threats from the “lame duck" session still in power and the potential changes that will come with new government officials.

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Supplement Usage Remains Steady

2010-11-01T06:39:00.000-07:00

From Nutraceuticals World

A consistent percentage of U.S. adults label themselves as supplement users, with 66% classifying themselves as such, according to a survey conducted by Ipsos-Public Affairs for the Council for Responsible Nutrition (CRN), Washington, D.C. In 2009, 65% identified themselves as supplement users compared with 64% in 2008, 68% in 2007 and 66% in 2006.

According to results from the 2010 CRN Consumer Survey on Dietary Supplements, regular supplement usage also remains steady. The online survey showed that nearly three-quarters of supplement users (74%) classify themselves as “regular” users, as opposed to occasional users (21%) or seasonal users (5%). In 2009, 73% of supplement users indicated they took supplements regularly; in 2008, 75%, and in 2007, 77% indicated similarly.

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Robinson Pharma Hires R and D, Quality Ops Staff

2010-10-20T06:24:00.000-07:00

From Natural Products INSIDER

Robinson Pharma Inc. (RPI) hired Emad Hassan, Ph.D., Hassen Nasri, Ph.D., and expanded its sales team. Emad Hassan obtained his undergraduate in pharmaceutical science with honors from the University of Alexandria, Egypt and completed his Ph.D. in pharmaceutics at the University of Georgia College of Pharmacy. An expert in drug delivery systems with experience in oral, parenteral, topical, transdermal, liquids, liquid encapsulation and nanotechnology, his record of achievement includes eight issued patents, more than 50 publications and presentations, and more than 200 pharmaceutical products now in the market.

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WILD Flavors, Sterling Technology Form Partnership

2010-10-20T06:22:00.000-07:00

From Nutraceuticals World

Adding to its Health Ingredient Technology & Solutions (H.I.T.S.) lineup, WILD Flavors, Erlanger, KY, has established a partnership with Sterling Technology, Brookings, SD, making WILD the exclusive provider of Immunel and Tegricel bioactive milk peptide products. The new partnership will combine Sterling's scientific research expertise in bioactive milk peptides with WILD’s product development and flavor expertise.

Building a Branded Ingredient It Starts and Ends with Science

2010-10-19T06:06:00.000-07:00

From Natural Products INSIDER

by Bob Green

Today, branded ingredients are in greater demand than ever before. This is not only due to recent quality issues in the marketplace, but also to the passage of the new cGMPs (current good manufacturing practices). While the responsibility for meeting cGMPs technically falls on finished goods manufacturers, it only follows that manufacturers will look to ingredient suppliers for scientifically supported ingredients that follow strict quality assurance and quality control (QA/QC) guidelines. Branded ingredients not only meet these criteria, they provide quality value, as well as safety, security and support—necessary for the long-term viability, confidence and stability of a consumer brand.
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ChromaDex Begins Clinical Trial on Pterostilbene

2010-10-18T06:05:00.000-07:00

From Nutraceuticals World

ChromaDex Corporation, Irvine, CA, has initiated a clinical study at the University of Mississippi for pTeroPure pterostilbene, which is chemically related to resveratrol. The novel ingredient is based on the grant of an exclusive worldwide license to all patent rights of pterostilbene from the University of Mississippi. In laboratory tests, pterostilbene has shown promise for improving cardiovascular health, glucose levels, anti-aging and cognitive function—and for possessing cancer-fighting properties.
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Announcement: Cost Effectiveness and Safety of Dietary Supplements Symposium

2010-10-17T12:15:00.000-07:00

You know that the misinformation regarding supplements in the mass media and on Capitol Hill really angers me, and as you know I have been known to take to the airwaves, videowaves and lecture halls to try to combat it.

Especially now with what has been going with the food "safety" bills in D.C. right now, there is no better time for a scientific symposium that focuses on the safety of nutritional supplements while also discussing the cost-effectiveness data, something particularly relevant in today's troubled, slowly recovering economy.

With that in mind, I wanted to remind all of you about a very exciting conference that's coming up in the second half of November, on Thursday, November 18th, entitled the:

Natural Health Research Institute (NHRI) 5th Annual Scientific Symposium, “Natural Products – Cost-Effectiveness & Safety of Dietary Supplements”
http://www.naturalhealthresearch.org/nhri/wp-content/uploads/2010/09/NHRI-Symposium-09.23.10.pdf

Session 1: Cost Effectiveness of Natural Products will be chaired by Ron Watson, PhD. Chairman of NHRI, Dr. Watson has edited 60 biomedical books, particularly in nutrition and food sciences. He has directed several NIH funded biomedical grants relating to immune function and cardiovascular effects. He is an internationally recognized CAM researcher, nutritionist and immunologist. Professor Watson is a distinguished member of several national and international nutrition, immunology, and cancer societies, having published 450 research papers and reviews.

Session 1 will also feature Dr. Paul Coates, director of the NIH Office of Dietary Supplements and Michael Morton, the cofounder of Nourish America (formerly called Vitamin Relief USA).

Session 2: Safety of Dietary Supplements will be chaired by Russell M. Jaffe, Ph.D., M.D. Dr. Jaffe is President of PERQUE LLC, a firm producing items for practitioners. Formerly he was an official at the National Institutes of Health and Clinical Center in Bethesda, the US Public Health Service, and on the editorial board of The New Physician. For the past four years he has been selected as one of America’s Top Physicians, and selected as International Scientist of the Year in 2003 at Oxford. His published research includes over 400 papers in the areas of clinical and nutritional immunology, toxic minerals, hormones, and chemical disruptors, and autoimmune disease.

Session 2 will also feature: Dr. Bruce Ames, Dr. Rick Kingston and Dr. John Hathcock.

The symposium, to be held at the Hilton at Indian Lakes Resort in Bloomingdale, Illinois will be attended by scientists, medical researchers, practitioners and other interested professionals. Additional information will be announced in the coming weeks.

As a board member of the NHRI, I am especially excited about this powerful symposium. We will be making additional information, including audio recordings, available in the near future for those reporters and industry science and safety executives who cannot physically be there.

News Flash: ‘Supplements Are Safe, Healthful and Well-Regulated’!

2010-05-19T14:19:00.000-07:00

By James J. Gormley

On March 25th, 1999, I was part of a live television debate on FOX-TV’s “Good Day New York” with a drug industry attorney on the topic: “Are dietary supplements regulated?”(1)

Needless to say, with all of the facts showing how well regulated dietary supplements were then, winning the debate was not a difficult accomplishment; I even had the host, Jim Ryan, on the side of supplement consumers about midway through the segment.
In fact, the regulations and laws governing nutritional supplements today are even more stringent than they were in 1999, when I did that show.
READ MORE

Chromium picolinate may boost elderly memory

2010-05-11T10:16:00.000-07:00

Writing in the findings published in Nutritional Neuroscience, scientists from the University of Cincinnati College of Medicine report that daily supplements of the compound improved learning, recall, and recognition memory tasks.
     Chromium is an essential trace mineral that occurs naturally in small amounts in some foods, including brewer's yeast, lean meat, cheese, pork kidney and whole grain bread and cereals. It is poorly absorbed by the human body but is known to play an important role in the metabolism of carbohydrate, fat and protein.

     Several reports have indicated that chromium picolinate is better absorbed by humans than other forms of the mineral.

     Twenty-six older adults were recruited to participate in the study and they were randomly assigned to 1,000 micrograms of chromium picolinate per day (Chromax, Nutrition 21) or placebo capsules for 12 weeks. The new study was supported by Nutrition 21.

      "These new study results support the findings that Chromax chromium picolinate can also improve glucose metabolism in the brain, resulting in improved brain function,” said James Komorowski, VP of research and development for Nutrition 21.
<<READ MORE>>

American Chronicle | Health Freedom: Consumers Take Charge

2010-05-10T07:24:00.000-07:00

American Chronicle | Health Freedom: Consumers Take Charge

American Chronicle | The DEA and Sports Doping Enforcement

2010-05-10T07:23:00.000-07:00

American Chronicle | The DEA and Sports Doping Enforcement

Orrin Hatch Letter to John McCain About S. 3002

2010-03-09T23:59:00.000-08:00

This letter was sent by Senator Orrin Hatch, senior member of the HELP committee, to Senator John McCain on March 4, 2010, in large part as a result of the massively successful letter-writing campaign initiated by Citizens for Health and several other groups.
Please click here.

9 Reasons S. 3002 Has to Go

2010-03-09T19:27:00.000-08:00

By James J. Gormley
http://www.citizens.org/?p=1965
1. No phase-in period or “effective date”. Since legitimate dietary supplement companies and health-food stores would not have even one day to come into compliance with the new law, they would effectively be breaking the law the day after S. 3002 is passed.
2. Registration of supplement licensors. S. 3002 would require outfits that license dietary supplements to register their “facilities” under the FDA Food Facility program established by the Bioterrorism Act of 2002. Including these requirements would go against the purposes of the Bioterrorism Act and would serve no useful purpose other than creating more bureaucracy and red tape.

3. Registration of health-food stores. S. 3002 is unclear as to whether the current retailer exception to the Bioterrorism Act registration requirement is intended to be honored for supplement retailers.

4. Product and ingredient registration. The product/ingredient registration process included in S. 3002 is unclear in its use of the terms “ingredients” and “labeling.” As worded, S. 3002 would apparently require duplicate, therefore unnecessary, registration of every product at every point in its distribution! This would be an incredible burden, one that would mandate annual updates, and one that would not protect any proprietary information that is not required on product labels but that that may be required to be submitted in the registration process.

5. Replacement of new dietary ingredient (NDI) requirements with an FDA positive list. FDA received information between 1996 and 1998 from dietary supplement trade associations to record ingredients believed to be marketed in the U.S. prior to the passage of DSHEA. If there is any lack of clarity as to what dietary ingredients are “old,” the agency should initiate rulemaking to formally adopt the ingredients directly submitted by the trade associations.

6. Retailer evidence of compliance. The bill’s proposal to require health-food stores to obtain evidence of compliance with product registration and NDI notifications is would be ridiculously burdensome and something that is not required for other regulated goods.

7. Civil penalties. The bill would establish new, unnecessary civil penalties despite the fact that current law already imposes adequate fines and penalties for violations of the Food Drug and Cosmetic Act.

8. Non-serious adverse event reports. The FDA itself has made it clear that it would not be helpful for the agency to receive boatloads of minor or trivial (and probably not substantiated) adverse event reports associated with dietary supplements. Under current law, dietary supplement companies are already required to maintain records of all adverse event reports for 6 years and the FDA has the authority to inspect these records at any time.

9. FDA recall and “cease distribution” authority. S. 3002, as well as other food safety legislation already introduced in the 111th Congress (such as S. 510), would provide FDA with authority to mandate products recalls when health risks are presented by marketed products, which is fine. However, what is not fine is that S. 3002 would obligate the agency to issue a “cease distribution” order for any supplement identified as adulterated or misbranded, even in the absence of any perceived health risk.

Anti-Supplement “Perfect” Storm Building in Washington

2010-02-24T19:17:00.000-08:00

By James J. Gormley
http://www.citizens.org/?p=1924

As if Senate Bill 3002 (S. 3002) were not more than enough to deal with, according to The Hill Rep. John Dingell (D-Mich.) is criticizing the Senate for not moving on Senate Bill 510 (S. 510).

Unfortunately, The Pew Charitable Trust has been assisting with a coordinated lobbying effort to press Senate leaders to bring the bill to the floor. Sandra Eskin, director of Pew’s food safety campaign, told The Hill that she is “cautiously optimistic” that a vote can occur in the first half of March, before the Senate’s next recess week starts on March 29.

Regan LaChapelle, a spokeswoman for Sen. Harry Reid (D-Nev.), told The Hill that the majority leader hopes to bring the bill to the floor either during the current work period or the next, which runs from April 12 to May 28. “It’s on our list of legislative priorities,” she said. “It could be in March or the next work period. Obviously we have many issues to address.”

House Republicans were split on H.R. 2749, with 54 supporting it and 122 opposed. GOP members who backed it include Reps. Michele Bachmann (Minn.), Joe Barton (Texas), Dave Camp (Mich.) and Greg Walden (Ore.).

After the House bill passed, Rep. Frank Lucas (R-Okla.) told The Washington Post: “The federal government will tell our farmers and ranchers how to do something they’ve been doing since the dawn of mankind. It goes too far in the direction of trying to produce food from a bureaucrat’s chair in Washington, D.C.”
Twenty House Democrats opposed the bill.

Now moreso than in recent memory, it is critical that we all stay tuned to these issues, keeping an eye out for our continuing posts and opportunities for action on S. 3002 and S. 510 — and whatever else floats down the Potomac that threatens DSHEA, our supplements and our health-food stores.

NPA Alerts Health-Food Stores to Dangers of S. 3002

2010-02-22T19:16:00.000-08:00

http://thegormleyfiles.blogspot.com/2010/02/npa-alerts-health-food-stores-to.html
According to the Natural Products Association (NPA) in an e-mail alert issued today, here is how S. 3002 would affect health-food stores:
All dietary supplements, whether vitamins, minerals, herbal products and others that were previously allowed under DSHEA, could be removed from the market under S. 3002. This legislation would mandate that every dietary supplement would have to go through a brand new process of government review (yet to be defined) in order to remain on store shelves.

For the first time in the history of food or drug law, retail establishments would need to register with the FDA. Failing to register could result in severe monetary penalties, up to two times your gross profit. Not complying with even minimal technical requirements, such as minor errors in registration, recordkeeping or reporting could be considered a criminal offense.

Retailers would also be required to obtain “adequate written evidence” from suppliers that each dietary supplement product meets all regulatory requirements. Again, failure to do so could result in severe monetary penalties.

Act now!

Upgrade Your Social Media Efforts

2010-02-17T18:18:00.000-08:00

By IMG Brandwire

Social media is no longer kids stuff. With over 325,000,000 members on Facebook (50% of whom are over 35 years old) and 44 million Twitter users, most businesses are scrambling to craft effective social media strategies. Although it’s tempting to just throw something out there, keeping a few tips in mind can multiply your results and create synergy between various activities.

Make it viral. In every social media message, incentivize your followers to forward or publicize your messages to others, who, in turn, can do the same. Top incentives include photos, videos, and engaging links. Also, be certain to include an app on all messaging that allows viewers to share your info on their own profiles with a single click.

Integrate it. Build on existing public relations and marketing campaigns. Your social media arm is designed to reach out and grab your followers’ attention, but it’s not intended to provide detailed information. Include a link in every post or tweet to your website or blog so viewers can peruse your offering in greater detail. And make sure that, once they get to your blog or website, there’s something novel and interactive there to keep them involved with your brand.
Enrich the content. The best way to show your followers you appreciate them is to have something to say before you say it. As with press releases, the consuming public is weary of posts and tweets that don’t offer anything interesting, unique or relevant. Before each communication, ask yourself “What tidbit am I providing my visitors that they will find worthwhile and want to pass along?” If there isn’t one, it’s time for a rewrite. In short, think before you tweet.

The DEA Should Take Over All Sports Doping Enforcement

2010-02-13T14:46:00.000-08:00

By James J. Gormley

In February 2010 in New Orleans, three men were charged by the U.S. Drug Enforcement Administration (DEA) with drug-trafficking Ecstasy, or MDMA (3-4-Methylenedioxymethamphetamine), a synthetic chemical that can be derived from an essential oil of the sassafras tree.

If convicted, the defendants face a possible maximum sentence of 20 years in prison, a $1 million fine and at least three years of supervised release for each count.

MDMA is also one of the easiest illegal drugs to obtain. Its effects are similar to those of amphetamines and hallucinogens. First developed as an appetite suppressant in 1912, MDMA was used as a psychotherapeutic tool and also started to become available on the street is the late 1970s and early 1980s. It wasn’t until 1985 that Ecstasy was made illegal. It is classified as a “Schedule 1” controlled substance along with other narcotics like heroin, cocaine and LSD.

One reason Ecstasy can be especially dangerous is the lack of content control. Ingredients are hard to get and manufacturers of the drug often use substitutes, mixing other harmful additives with the already dangerous mix. This practice is so common that “drug test kits” are often sold with the drug so users can test for purity.

Because of the uncertainties about the drug sources, pharmacological agents, chemicals used to manufacture them, and possible contaminants, it is difficult to measure the toxicity, consequences and symptoms that might be expected.

Herbal Ecstasy is another form of MDMA that is composed of ephedrine or pseudoephedrine and caffeine from the kola nut. Also sold in tablet form, Herbal Ecstasy can cause permanent brain damage and death. Though not currently classified as a controlled substance, Herbal Ecstasy shares many of the same qualities and effects as MDMA. Also known as Cloud 9, Herbal Bliss, Ritual Spirit, Herbal X, GWM, Rave Energy, Ultimate Xphoria and X.

Anabolic Steroids
Anabolic steroids are synthetically produced versions of the naturally occurring male hormone, testosterone. Both males and females have testosterone produced in their bodies: males in the testes, and females in the ovaries and other tissues. The full name for this class of drugs is androgenic (promoting masculine characteristics) anabolic (tissue building) steroids (the class of drugs).

Some of the common street names for anabolic steroids include: arnolds, gym candy, pumpers, 'roids, stackers, weight trainers and juice. Currently, there are more than 100 different types of anabolic steroids that have been developed, and each requires a prescription to be used legally in the U.S.

Anabolic steroids can be taken orally, injected intramuscularly, or rubbed on the skin when in the form of gels or creams. These drugs are often used in patterns called cycling, which involves taking multiple doses of steroids over a specific period of time, stopping for a period, and starting again. Users also frequently combine several different types of steroids in a process known as stacking. By doing this, users, more properly abusers, believe that the different steroids will interact to produce an effect on muscle size that is greater than the effects of using each drug individually.

Another mode of steroid use is called "pyramiding." With this method abusers slowly escalate steroid use (increasing the number of drugs used at one time and/or the dose and frequency of one or more steroids), reach a peak amount at mid-cycle and gradually taper the dose toward the end of the cycle. The escalation of steroid abuse can vary with different types of training. Bodybuilders and weight lifters tend to escalate their dose to a much higher level than do long distance runners or swimmers.

Legislation and Enforcement
On March 16th 2004, Joseph Rannazzisi, then deputy director of the DEA's Office of Diversion Control, said in testimony before the House Subcommittee on Crime, Terrorism and Homeland Security:

"The DEA has one mission: to protect the public from dangerous drugs. However, the current law regarding steroids causes regulatory delay, especially with respect to steroids that we know are hormonally, chemically or pharmacologically related to testosterone. Because DEA’s authority extends only to controlled substances, steroids that are not classified as controlled substances continue to fall outside our jurisdiction. H.R. 3866 [The Anabolic Steroid Control Act of 2004 ] will correct this problem."

Well, the Anabolic Steroid Control Act passed in October 2004.

On the bill's passage, one of its sponsors, Sen. Orrin Hatch (R-UT), remarked:

"Under this bill, clever chemists will no longer be able to dodge the law by disguising their chemicals to skirt the legal definition of a steroid. Our bill gives the Drug Enforcement Agency the power to schedule nearly any steroid precursor now or in the future--giving the law flexibility we don't have to play catch-up with every new andro look-alike that comes along."

On September 29, 2009, the DEA's Rannazzsi, now deputy assistant administrator, said this in testimony before the Subcommittee on Crime and Drugs:

"Although DEA does not have the authority to enforce DSHEA [the Dietary Supplement Health and Education Act of 1994], DEA does have statutory authority to investigate incidents involving the illegal manufacture and distribution of anabolic adrenergic steroids in the dietary supplement market. [...] DEA has the authority and responsibility to investigate companies that are marketing products as dietary supplements that are adulterated with controlled substances."

As well the DEA should; if yogurt were suddenly used as a delivery vehicle for sports steroids, would our guardians of public health call for a new law restricting access to yogurt or would increased enforcement and enforcement funding be directed to the DEA to get the job done? The latter, I would think.

If supplements are being adulterated by illegal labs, why then should supplements get a bad rap? Steroids and sports doping is all about unethical pharmacies and illegal labs.

Case in point, in January 2009, a 198-count DEA indictment was unsealed charging 12 pharmacists and pharmacy owners with participating in a conspiracy that dispensed and sold thousands of dosages of anabolic steroids, including powerful veterinary steroids approved for animal use only.

Another case in point: in October 2009 the DEA announced the completion of a 10-month undercover investigation into an illegal anabolic steroid manufacturing ring that led to three arrests. In the raid, agents seized over 500 vials and 1,850 capsules of anabolic steroid pills.

While the U.S. Food and Drug Administration (FDA) has been involved in sweeps relating to the illegal sale of unapproved or misbranded drugs, such as the recent Internet sweep in November 2009 called the "International Internet Week of Action," many observers, including this commentator, strongly believe that all investigation and enforcement of sports doping and illegal steroid distribution and use should immediately be more clearly placed under the aegis of the DEA, as sports doping is not a problem of food products (such as supplements) but a problem of drugs---a problem of dope, pure and simple.

The Dietary Supplement Excuse

2010-02-07T10:37:00.000-08:00

[With the DSSA bill, S. 3002, now up for vigorous debate, it's worth taking a look back to this article of mine from 2007, as most of the same issues still apply]

By James J. Gormley

On November 15th, 2007, home-run legend Barry Bonds was indicted for allegedly lying under oath to a grand jury about his use of performance-enhancing steroids.

In the New York Daily News coverage of the story, Victor Conte, founder of the Bay Area Laboratory Cooperative (BALCO) that allegedly supplied numerous world-champion athletes with performance enhancers, was quoted as speculating that “Bonds could have tested positive due to a contaminated dietary supplement.”

Right. Perhaps Conte was borrowing an excuse from nearby San Diego. On October 31st, The Canadian Press reported that San Diego Padres’ center fielder, Mike Cameron, was suspended for 25 games after testing positive a second time for a banned stimulant. Cameron reportedly said that he thinks he took a tainted supplement.

On October 5th, Olympic gold medalist, Marion Jones-Thompson, pled guilty to charges of making false statements to federal agencies in connection with two investigations, one of which was related to the BALCO steroid cases.

A Checkered Past
According to the Seattle Post-Intelligencer, the BALCO timeline extends back as far as 1988, when Conte was providing free blood and urine testing and dietary supplements to a group of athletes he referred to as the “BALCO Olympians,” whom he joined at the 1988 Summer Olympics in Seoul, Korea.

After 1996, Conte formed what he called the ZMA Track Club, which, according to the Seattle Post-Intelligencer,“served as a marketing tool and claimed among its athletes Marion Jones and Tim Montgomery.” According to the paper, “Bonds’ arrival in 2000 signaled even greater opportunities.”

According to USA Today, 2002 was when the federal investigation of BALCO began, followed by a raid of BALCO’s offices in September 2003 and a 42-count indictment against four men (including Conte) alleging a conspiracy to distribute anabolic steroids and misbranded drugs, in addition to money laundering.

In the midst of all of this, in February 2003, Baltimore Orioles’ pitcher, Steve Bechler, died due to “a constellation of risk factors,” according to Broward County medical examiner, Dr. Joshua Perper, including: “being significantly overweight and not well conditioned”; “not yet being acclimatized to the warm climate of Florida” and “having hypertension and abnormal liver function.”

These extremely important facts were not mentioned at the time by Rep. Henry Waxman (D-CA) when he used this case as leverage for his anti-supplement intifada now, were they? In fact, according to April 2003 comments by attorneys Marc Ullman and Seth Flaum that were submitted to the FDA regarding the agency’s proposed rule for dietary supplements containing ephedra alkaloids:

“This information was left out of many of the news reports that followed Mr. Bechler’s death and has never been acknowledged by any FDA official.”

Picking up the doping follies again in December 2004, grand jury testimony appeared in the San Francisco Chronicle in which the paper said Bonds “admitted to unknowingly using steroids during the 2003 season. In July 2005, Conte pled guilty to steroid distribution and money laundering. Reports emerged in January 2007, said USA Today, that Bonds tested positive for amphetamines during the 2006 season.

"Oh, Those Tainted Dietary Supplements" or The Dietary Supplement Excuse
Which brings us back to the present, where we apparently have entered a new age, the age of "The Tainted Dietary Supplement Excuse," an excuse that almost anyone now who is caught improperly using spiked products cooked up in some lab can apparently take advantage of.

Many of these product abusers would have us believe that they are hapless fools, doe-eyed innocent pawns of diabolical masterminds who nefariously sabotage the benign nutritional products that are foisted upon them. Hardly.

Maybe we should suggest that users of heroin could claim that they used an opium poppy extract unknowingly tainted with morphine?

Perhaps people busted for cocaine possession could claim that the Erythroxylon shrub extract they were taking was tainted with cocaine alkaloids?

Who cares about athletes exercising personal responsibility and playing by the rules when stadiums are packed to the rafters and team (or even national) glory is at stake? Isn’t it that much easier for coaches or commissioners to look the other way when championship rings or gold medals are being handed out?

It’s not about dietary supplements but about greed, money, politics and power. The pharmaceutical lobby is very powerful. The money at stake behind sports is staggering. Our need for sports heroes is also very compelling.

America needs a scapegoat. How convenient that dietary supplements continue to be easy targets. Why don’t we blame pharmaceuticals? At least, we know they harm and kill people in droves.

Oh right—sorry. Forgot about all the pharma ads in newspapers, magazines and TV and their stranglehold on Congress and the FDA.

We’ll have to come up with another idea.

Rick Kaiser to Head Up Sales for OmniActive Technologies

2010-02-03T13:30:00.000-08:00

SHORT HILLS, N.J., February 3, 2010 - OmniActive Health Technologies today announced that Rick Kaiser has joined the company as Director of Sales.

In this role, Kaiser will be responsible for securing new accounts, managing sales activities including lead generation and trade show activity, and marketing the company's proprietary weight management and eye health ingredients. Kaiser brings more than 30 years of sales experience in both the pharmaceutical and nutraceutical industries.

"We are pleased to have Rick join the OmniActive team and feel that
his extensive industry experience and strong reputation will be invaluable as we continue to grow and strengthen our sales initiatives," noted Hiren Doshi, Vice President, OmniActive Health
Technologies. "We are confident in Rick's ability to effectively
communicate the health benefits and clinical science behind our ingredients and continue to expand our client base across North America."

Kaiser has held numerous executive sales and marketing positions at leading companies including Advana Science, Inc., Bioriginal Food and Science Corporation, Nutrition 21 and Bristol-Myers. He comes to OmniActive with solid experience in brand development, account
generation, sales force management and training, and marketing of natural ingredients.

About OmniActive Health Technologies:
OmniActive Health Technologies, Ltd. (www.omniactives.com) supplies a range of innovative, scientifically validated, active natural ingredients for healthcare, food and personal care applications. The company offers the world's first and only complete source of both free lutein and lutein esters, as well as a unique combination of lutein and zeaxanthin isomers, under its Lutemax(R) line of ingredients. OmniActive also offers the weight loss ingredient Capsimax(TM) Capsicum Extract, manufactured from the active principles of hot red peppers, as well as Capsimax(TM) Plus Blend, a proprietary blend containing Capsimax Capsicum Extract and other natural thermogenic and performance-boosting agents for use in a range of weight management and sports nutrition products. OmniActive has a wholly owned US subsidiary, OmniActive Health Technologies, Inc. in Short Hills, NJ, and conducts operations from its manufacturing, R&D and corporate facilities at Pune, Mumbai, Thane and Cochin, India. OmniActive's manufacturing facilities are certified for the quality and food safety management systems under ISO-22000(2005) and cGMP standards.

###

Press Contact:
Courtney Jacobs Morton
Integrated Marketing Group
P: 801-538-0777 x102
courtneym@imgbranding.com

Novus Selects IMG; Launches Human Nutrition Division

2010-01-28T14:12:00.000-08:00

NOVUS INTERNATIONAL SELECTS INTEGRATED MARKETING GROUP TO ASSIST IN LAUNCHING, MARKETING ITS NEW HUMAN NUTRITION DIVISION

SALT LAKE CITY, January 27, 2010 - Integrated Marketing Group (IMG) was chosen by Novus International to help create an identity for and formally launch Stratum Nutrition, the company's newly formed human nutrition division. IMG will help manage overall branding efforts including logo development, strategic positioning and creative development, as well as execute a targeted public relations campaign.

As a global leader in animal agriculture health and nutrition, Novus International has been playing an active, albeit behind-the-scenes role in human nutrition since its inception in 1991. The company's core competency is in creating science-based, nutritional solutions for the daily health and welfare concerns that farmers have for their animals. Drawing upon this nutritional solutions-based business
approach, Novus is launching Stratum Nutrition, a dedicated human nutrition division that will include ingredients and technologies that can be directly utilized in supplements, beverages and foods.

"We look forward to working with Novus to introduce Stratum Nutrition to the industry, as well as collaborate on branding efforts for the company's specialty ingredients," stated Jeff Hilton, IMG co-founder and partner. "Novus's commitment to product innovation, clinical research and intellectual property will greatly enhance Stratum Nutrition's success in the human health market."

"IMG's knowledge of the dietary supplement, food and beverage ingredient markets made them an ideal partner to help Novus brand and unveil our dedicated human nutrition division, Stratum Nutrition," stated Thad Simons, president and CEO, Novus International. "We feel their expertise is invaluable as we introduce our portfolio of innovative specialty ingredients for human health applications."

About Integrated Marketing Group:
Integrated Marketing Group (www.imgbranding.com) is a decade-old marketing and brand consultancy created to optimize all aspects of marketing communications including: corporate identity, advertising, public relations, internet marketing, research, packaging, merchandising, sales promotion, educational programs, trade show presence and direct marketing. Its principals have created a marketing firm with a diverse background of creative development and strategic planning skills to serve the healthy lifestyles, food and personal care industries. IMG was the first agency in the United States to certify in the Federal Trade Commission Advertising Compliance Course for dietary supplements. For branding articles and resources, visit www.imgbrandwire.com

About Stratum Nutrition:
Stratum Nutrition, a division of Novus International, focuses on human nutrition through specialty ingredients for manufacturers and marketers of foods, beverages and dietary supplements. Stratum leverages the Novus core competencies in nutritional research and innovation as well as the corporate commitment to protecting the environment by actively monitoring economic, environmental and social factors to ensure that its ingredients offer safe, efficient and sustainable health solutions. To learn more about Stratum Nutrition, please contact Jeremy Moore at 888.403.5039.

# # #

Press Contact:
Courtney Jacobs Morton
Integrated Marketing Group
P: 801-538-0777 x102
courtneym@imgbranding.com

Nutraceuticals International Now Kosher

2010-01-28T13:53:00.000-08:00

Nutraceuticals International® LLC, supplier of high quality raw ingredients, has earned kosher certification by Earth Kosher on December 30, 2009. This certification was applied to over 200 of their products including some of the top sellers such as: Bilberry, Boswellia Serrata, Goji, Green Tea, Piper Longum, Pomegranate, and Tribulus Terrestris. All necessary documents will be provided upon customer request and are valid until December 22, 2010. Please contact Nutraceuticals International for more information regarding their newly kosher certified products. For more information, contact the company: 1-888-541-1284.

Vitamin D supplements could fight Crohn's disease :: News :: Natural and Nutritional Products Industry Center

2010-01-27T00:00:00.000-08:00

Vitamin D supplements could fight Crohn's disease :: News :: Natural and Nutritional Products Industry Center

Goya Foods to Donate Over Three Hundred Thousand Pounds of Food to Help Feed the Victims of Haiti Earthquake

2010-01-24T19:04:00.000-08:00

Goya Foods to Donate Over Three Hundred Thousand Pounds of Food to Help Feed the Victims of Haiti Earthquake

Whole Foods Market's Team Members Put Company on FORTUNE Magazine's '100 Best Companies To Work For' List for 13th Consecutive Year

2010-01-24T19:03:00.000-08:00

Whole Foods Market's Team Members Put Company on FORTUNE Magazine's '100 Best Companies To Work For' List for 13th Consecutive Year

The AVEENO(R) Brand Unveils the AVEENO(R) Beauty Experience at the 2010 Sundance Film Festival

2010-01-24T19:02:00.000-08:00

The AVEENO(R) Brand Unveils the AVEENO(R) Beauty Experience at the 2010 Sundance Film Festival

Natural Products Association Invites Advocates to Rally on Capitol Hill, March 23, 2010

2010-01-24T19:00:00.000-08:00

Natural Products Association Invites Advocates to Rally on Capitol Hill, March 23, 2010

Whole Foods Market(R) Customers Give $1 Million for Haiti Relief

2010-01-24T18:59:00.000-08:00

Whole Foods Market(R) Customers Give $1 Million for Haiti Relief

Bloomberg State of City Pledge to Green Dirty Heating Oil Will Cut Pollution Linked to Disease

2010-01-24T18:58:00.001-08:00

Bloomberg State of City Pledge to Green Dirty Heating Oil Will Cut Pollution Linked to Disease

ABC Publishes Monograph on Scientific and Clinical Research of Pycnogenol(R)

2010-01-24T18:58:00.000-08:00

ABC Publishes Monograph on Scientific and Clinical Research of Pycnogenol(R)

Whole Foods Market, Inc. Announces First Quarter Earnings Conference Call and Webcast

2010-01-24T18:57:00.001-08:00

Whole Foods Market, Inc. Announces First Quarter Earnings Conference Call and Webcast

Get Real... Get Raw!!! Provides 'Green' Healthy Living to Project H.O.M.E.

2010-01-24T18:57:00.000-08:00

Get Real... Get Raw!!! Provides 'Green' Healthy Living to Project H.O.M.E.

Rainbow Light Introduces EcoGuard Sustainable Packaging

2010-01-24T18:56:00.000-08:00

Rainbow Light Introduces EcoGuard Sustainable Packaging

Eggland's Best's Now Even More Nutritious

2010-01-24T18:55:00.000-08:00

Eggland's Best's Now Even More Nutritious

NY Coalition Opposes Governor Paterson's Proposed Sugar Sweetened Beverage Tax

2010-01-24T18:49:00.001-08:00

NY Coalition Opposes Governor Paterson's Proposed Sugar Sweetened Beverage Tax

Anheuser-Busch InBev North America Responds to Crisis in Haiti With Drinking Water, Cash Donations

2010-01-24T18:49:00.000-08:00

Anheuser-Busch InBev North America Responds to Crisis in Haiti With Drinking Water, Cash Donations

Kashi Company Introduces a Crispy New Way to Start the Day

2010-01-24T18:46:00.000-08:00

Kashi Company Introduces a Crispy New Way to Start the Day

Online Auction Sites Selling Fake Weight Loss Products

2010-01-24T18:45:00.000-08:00

Online Auction Sites Selling Fake Weight Loss Products

Pacific College of Oriental Medicine in Chicago Appoints New Campus Director, Dr. Edward Lamadrid

2010-01-24T18:44:00.000-08:00

Pacific College of Oriental Medicine in Chicago Appoints New Campus Director, Dr. Edward Lamadrid

U.S. Supreme Court to Review Delay on Roundup Ready(R) Alfalfa

2010-01-24T18:41:00.000-08:00

U.S. Supreme Court to Review Delay on Roundup Ready(R) Alfalfa

Vitamin Angels Responds to Haiti Disaster

2010-01-24T18:40:00.000-08:00

Vitamin Angels Responds to Haiti Disaster

Whole Foods Market(R) Sets Up Haitian Earthquake Relief Drive

2010-01-24T18:39:00.001-08:00

Whole Foods Market(R) Sets Up Haitian Earthquake Relief Drive

Spa & Resort/Medical Aesthetics Conference and Expo Becomes Part of the HBA Global(R) Beauty Week(TM) in 2010

2010-01-24T18:39:00.000-08:00

Spa & Resort/Medical Aesthetics Conference and Expo Becomes Part of the HBA Global(R) Beauty Week(TM) in 2010

drank(TM) Continues To Mellow the St. Louis Market As the Relaxation Trend Spreads

2010-01-24T18:34:00.000-08:00

drank(TM) Continues To Mellow the St. Louis Market As the Relaxation Trend Spreads

Organic Consumers Association and Certified Organic Brands File Federal Complaint with USDA Against Organic Personal Care 'Cheater Brands'

2010-01-24T18:33:00.000-08:00

Organic Consumers Association and Certified Organic Brands File Federal Complaint with USDA Against Organic Personal Care 'Cheater Brands'

Nutraceuticals Emerge in the Spotlight as Accent on Healthy Living Intensifies, Finds Frost & Sullivan

2010-01-24T18:32:00.000-08:00

Nutraceuticals Emerge in the Spotlight as Accent on Healthy Living Intensifies, Finds Frost & Sullivan

Multiple Organics Educates Underserved Children About Organic Food

2010-01-24T18:31:00.000-08:00

Multiple Organics Educates Underserved Children About Organic Food

VitaminSpice Enters Into an Agreement With Amdistco for Iron Chef America Co-Branded VitaminSpice Seasonings

2010-01-24T18:30:00.001-08:00

VitaminSpice Enters Into an Agreement With Amdistco for Iron Chef America Co-Branded VitaminSpice Seasonings

Organic. It's Worth it in Schools.

2010-01-24T18:30:00.000-08:00

Organic. It's Worth it in Schools.

Traditional Medicinals(R) Announces Two New Herbal Teas for the Digestive System

2010-01-24T18:29:00.000-08:00

Traditional Medicinals(R) Announces Two New Herbal Teas for the Digestive System

Beer Lovers Thirst For Samuel Adams(R) Noble Pils; Brewers Choose It As The New Spring Seasonal Beer

2010-01-24T18:28:00.001-08:00

Beer Lovers Thirst For Samuel Adams(R) Noble Pils; Brewers Choose It As The New Spring Seasonal Beer

Proposed Settlement Will Make Over $25 Million Available to Individuals and Entities Who Purchased Vitamin Products

2010-01-24T18:28:00.000-08:00

Proposed Settlement Will Make Over $25 Million Available to Individuals and Entities Who Purchased Vitamin Products

Natural Magic Eco-Herbal Skin Care to be Featured in Golden Globes Gift Bags

2010-01-24T18:26:00.000-08:00

Natural Magic Eco-Herbal Skin Care to be Featured in Golden Globes Gift Bags

Mizkan Acquires Exclusive Distribution Rights of ANGOSTURA(TM) Aromatic Bitters

2010-01-24T18:24:00.000-08:00

Mizkan Acquires Exclusive Distribution Rights of ANGOSTURA(TM) Aromatic Bitters

Nordic Naturals(R) Offers Monthly Educational Webinar Program 'Live with Stuart Tomc' for Consumers on Important Public Health Initiative Topics

2010-01-24T18:23:00.000-08:00

Nordic Naturals(R) Offers Monthly Educational Webinar Program 'Live with Stuart Tomc' for Consumers on Important Public Health Initiative Topics

New Probiotic Website Targets Healthcare Professionals in the U.S.

2010-01-24T18:22:00.001-08:00

New Probiotic Website Targets Healthcare Professionals in the U.S.

Earth's Best(R) Celebrates Its 25th Birthday by Ringing the Nasdaq Stock Market Opening Bell

2010-01-24T18:22:00.000-08:00

Earth's Best(R) Celebrates Its 25th Birthday by Ringing the Nasdaq Stock Market Opening Bell

'Herbal Insights' Debuts on PBS TV Series

2010-01-24T18:20:00.000-08:00

'Herbal Insights' Debuts on PBS TV Series

Hain Celestial to Present at the Cowen and Company Consumer Conference on January 11, 2010

2010-01-24T18:19:00.001-08:00

Hain Celestial to Present at the Cowen and Company Consumer Conference on January 11, 2010

Gormley NPI Consulting

IPA founder: EU probiotic approach is “dirty pool”

Inaccurate media coverage and misguided attempts at regulation? A year in consumer health advocac...

Citizens for Health NDI guidance withdrawal petition signatures approach 15,000

You Did It!!!!!

10,000 Americans Tell FDA: Withdraw the “NDI Draft Guidance”!!

Sign the Petition! Time to Knock It Out of the Park!

10,000 Signatures in 10 Days; We Can Do It!

Petition to Demand that the FDA Withdraws the NDI Draft Guidance!

A Defining Moment for the Dietary Supplement Industry

IFT Interview With Dr. Philip Nelson

Natural Products Foundation – John R. Carlson Memorial

Citizens for Health: NDI guidance ‘contravenes spirit and letter of DSHEA'

Citizens for Health Launches Campaign Against FDA’s NDI Guidance

Jarrow Formulas Challenges FDA on NDIs With 128-Item Freedom of Informatio​n Request

Norman R. Farnsworth, Renowned Medicinal Plant Researcher, Dies at 81

FDA Extends NDI Draft Guidance Comment Period by 60 Days

Trade Associations: 45-Day NDI Draft Guidance Extension Request Reasonable

FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

What’s old is new again? The FDA takes aim at modern science and innovation

Quality: Giving It A Chance

Capitol Comments: Dissecting FDA’s NDI Guidance

Associations Oppose Supplement Labeling Bill

Jarrow Formulas Calls for 1-Year NDI Draft Comment Extension

Rising Up Against Durbin’s Bill

On-Trend Products Defying Economic Downturn

Packaged Facts Reveals Food, Beverage & Snack Insights

Negative EU Claims List Won’t Come Before Summer 2012

NOW International Earns IL Export Award

New Durbin Bill Would Change DSHEA

New Durbin Bill Goes After Supplements

FDA’s New Take on Imports

Dietary Supplement Industry and the Park Doctrine

SIDI Working Group Comments on FSMA

Nutrition 21’s Chromium Histidinate Protects Brain

FDA New Dietary Ingredient Guidance Leaked

More Regulation on the Way For Global Supplement Market

Daniel Fabricant Moves From NPA to FDA

NOW Foods Develops Screening Method Against Adulteration

Can FDA Afford to Implement New Food Safety Measures?

Nutrition 21 to Enter Cough/Cold Market

NDIs, Adulteration on AHPA’s Radar

Nutrition 21 Awarded Grant for Diabetic Technology

Election Brings Potential Threats to Natural Product Industry

Supplement Usage Remains Steady

Robinson Pharma Hires R and D, Quality Ops Staff

WILD Flavors, Sterling Technology Form Partnership

Building a Branded Ingredient It Starts and Ends with Science

ChromaDex Begins Clinical Trial on Pterostilbene

Announcement: Cost Effectiveness and Safety of Dietary Supplements Symposium

News Flash: ‘Supplements Are Safe, Healthful and Well-Regulated’!

Chromium picolinate may boost elderly memory

American Chronicle | Health Freedom: Consumers Take Charge

American Chronicle | The DEA and Sports Doping Enforcement

Orrin Hatch Letter to John McCain About S. 3002

9 Reasons S. 3002 Has to Go

Anti-Supplement “Perfect” Storm Building in Washington

NPA Alerts Health-Food Stores to Dangers of S. 3002

Upgrade Your Social Media Efforts

The DEA Should Take Over All Sports Doping Enforcement

The Dietary Supplement Excuse

Rick Kaiser to Head Up Sales for OmniActive Technologies

Novus Selects IMG; Launches Human Nutrition Division

Nutraceuticals International Now Kosher

Vitamin D supplements could fight Crohn's disease :: News :: Natural and Nutritional Products Industry Center

Goya Foods to Donate Over Three Hundred Thousand Pounds of Food to Help Feed the Victims of Haiti Earthquake

Whole Foods Market's Team Members Put Company on FORTUNE Magazine's '100 Best Companies To Work For' List for 13th Consecutive Year

The AVEENO(R) Brand Unveils the AVEENO(R) Beauty Experience at the 2010 Sundance Film Festival

Natural Products Association Invites Advocates to Rally on Capitol Hill, March 23, 2010

Whole Foods Market(R) Customers Give $1 Million for Haiti Relief

Bloomberg State of City Pledge to Green Dirty Heating Oil Will Cut Pollution Linked to Disease

ABC Publishes Monograph on Scientific and Clinical Research of Pycnogenol(R)

Whole Foods Market, Inc. Announces First Quarter Earnings Conference Call and Webcast

Get Real... Get Raw!!! Provides 'Green' Healthy Living to Project H.O.M.E.

Rainbow Light Introduces EcoGuard Sustainable Packaging

Eggland's Best's Now Even More Nutritious

NY Coalition Opposes Governor Paterson's Proposed Sugar Sweetened Beverage Tax

Anheuser-Busch InBev North America Responds to Crisis in Haiti With Drinking Water, Cash Donations

Kashi Company Introduces a Crispy New Way to Start the Day

Online Auction Sites Selling Fake Weight Loss Products

Jarrow Formulas Challenges FDA on NDIs With 128-Item Freedom of Information Request