Tuesday, November 22, 2011

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

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Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petitions in 10 days calling for Congress to withhold FDA appropriations until this unaccountable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!

Friday, November 18, 2011

Petition to Demand that the FDA Withdraws the NDI Draft Guidance!

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Let's call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the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in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA."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


Friday, November 11, 2011

A Defining Moment for the Dietary Supplement Industry

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.

Friday, September 16, 2011

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

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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Monday, September 12, 2011

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

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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Thursday, September 8, 2011

FDA Extends NDI Draft Guidance Comment Period by 60 Days

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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Wednesday, September 7, 2011

Trade Associations: 45-Day NDI Draft Guidance Extension Request Reasonable

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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Thursday, September 1, 2011

Capitol Comments: Dissecting FDA’s NDI Guidance

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

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

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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Thursday, July 7, 2011

Rising Up Against Durbin’s Bill

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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Friday, July 1, 2011

On-Trend Products Defying Economic Downturn

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

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

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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Thursday, June 30, 2011

NOW International Earns IL Export Award

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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Wednesday, June 29, 2011

New Durbin Bill Would Change DSHEA

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.

Tuesday, June 28, 2011

New Durbin Bill Goes After Supplements

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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Monday, June 20, 2011

FDA’s New Take on Imports

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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Monday, June 13, 2011

Dietary Supplement Industry and the Park Doctrine

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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Wednesday, June 1, 2011

SIDI Working Group Comments on FSMA

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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Tuesday, April 26, 2011

Nutrition 21’s Chromium Histidinate Protects Brain

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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Friday, April 1, 2011

FDA New Dietary Ingredient Guidance Leaked

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.

Tuesday, March 1, 2011

More Regulation on the Way For Global Supplement Market

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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Wednesday, February 2, 2011

Daniel Fabricant Moves From NPA to FDA

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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Thursday, January 20, 2011

NOW Foods Develops Screening Method Against Adulteration

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.

Monday, January 3, 2011

Can FDA Afford to Implement New Food Safety Measures?

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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