Natural Products Industry Dot Edu

By James J. Gormley

These days there is much discussion — as there should be — about standards, certifications, and what’s in a given bottle of supplements (such as superior quality ingredients) and what’s not in it (e.g., GMO-free and gluten-free).

But what can empower a company to confidently map out the life trajectory of a dietary supplement from sprout to shelf? Education.

It is fortunate, then, for producers and consumers that the Natural Products Association (NPA) and UL (Underwriters Laboratories), a “global independent safety science company with more than a century of expertise innovating safety solutions” are now working together to offer “increased educational opportunities to NPA members,” according to a recent NPA announcement.

Having served on the NPA Education Committee some years ago, and having helped companies comply with regulatory requirements since then, I can confidently say that this educational boost will help participating member companies learn, brush up on, and master what is needed to navigate the oftentimes confusing seas of regulatory compliance.

From preparing for cGMP inspections, to cGMP quality control requirements, to production and process controls, to structure-function claims and labeling, to SOPs and more, the planned educational modules appear to address a whole range of critical areas important to the natural products industry.

The new partnership will combine NPA’s regulatory and compliance expertise with “top-notch training modules from EduNeering, the online regulatory training division of UL,” according to the NPA.

“Given the combined reputation and expertise of both NPA and UL, our collaborative efforts to bring elevated education to the natural products industry is the logical next step for both organizations,” said Daniel Fabricant, Ph.D., CEO of the NPA.

“NPA brings a level of regulatory expertise in Dr. Fabricant and Dr. Corey Hilmas that is unmatched in the dietary supplement industry, and UL is very pleased to be partnering with them in this new endeavor. Through this alliance, the industry and consumers will undoubtedly be better served,” said Mike O’Hara, general manager of global nutraceuticals for UL.

“Our combined vision is to see one program the industry can turn to for dietary supplement education, and we see this being that program,” Dr. Fabricant added. “We anticipate this to be the start of a lasting relationship between NPA and UL that will reflect this shared vision and impact our industry in a very profound and meaningful way.”

Given UL’s global recognition and universal adoption, I anticipate good things coming out of this collaboration, including a more savvy industry marketplace that is better equipped and stronger than ever before, which will benefit the industry and consumers.
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Trade Organization Overload?

By James J. Gormley

The above headline comes from the provocative question I was asked for this article: Are there too many trade associations?

“The question is not whether we have too many trade associations, or not enough, but whether they are getting the job done,” notes Jarrow Rogovin, founder and president of Los Angeles, CA-based Jarrow Formulas.

Rogovin, who might be regarded as a one-man trade association himself, has a point. Every trade association has its strong suits and its specialties, and so, once again, the answer to the ultimate existential question, “Who am I?,” should serve as a signpost as to which organization might be best suited to your company’s needs.

If you are heavily involved in herbals, AHPA might be the right organization for you; if OTCs are your bailiwick, then CHPA is the right group for your firm.

On the other hand, if you make or sell a variety of products, CRN, NPA or UNPA might be well suited for you, and if you want to reach retailers as well, that’s where NPA comes in again.

There are also associations that specialize in certain categories, such as GOED and the IPA.

Keep in mind, however, that you can join more than one association, and probably should consider doing so if your company is able, since in that way you maximize your firm’s chances of being on the front lines of promoting and defending the natural products industry, whoever is leading the charge.

Also remember that the most strategically minded trade associations are able to forge powerful collaborations with credible consumer groups on important or watershed issues.

A perfect, recent, example of this was the coalition of all of the natural products trade groups, plus consumer organization Citizens for Health, which together successfully campaigned for the passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the AER Bill) in June 2006.

Another, more recent, example is Citizens for Health’s push in support of AHPA’s KeepSupplementsClean.org initiative.

There are other credible consumer organizations out there too, including, but not limited to, the Alliance for Natural Health (ANH), the National Health Federation (NHF), and Your Voice for Health (YVH).

Get these questions answered before you join any trade organization:

1. Is this organization mainly focused on my channel of trade or type of business?
2. Does the organization have a “1 member, 1 vote” policy for full members (it should)?
3. Is the work the organization does focused on rubber-hits-the-road areas I want it to focus on?
4. Is the organization more concerned about “having a seat at the table” than shaking up regulators and Congress?
5. Does the organization provide ample opportunities for all voting members to serve on the board and committees?
6. Is the organization respected and feared on Capitol Hill and in College Park, MD? (The first is great, but the latter is even better!)
7. Does the organization plan to collaborate more with credible consumer organizations so that we, as an industry, can present a united front, one that cannot be dismissed as “industry only”?

And depending on how satisfied you are with the answers you get, along with recommendations from colleagues who are already members, you will be able to choose wisely.

A Trade Associations Primer

• AHPA (American Herbal Products Association) is comprised of more than 300 domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products.
• CHPA (Consumer Healthcare Products Association) represents more than 75 manufacturer member companies and 150 associate member companies. Manufacturer members manufacture or market OTC medicines and dietary supplements, including contract and private label manufacturers.
• CRN (Council for Responsible Nutrition): a Washington, D.C.-based trade association representing 100+ dietary supplement manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers.
• GOED (Global Organization for EPA and DHA Omega-3s) is a trade association whose goals are to increase consumption of omega-3s to adequate levels around the world and to ensure that the industry is producing quality omega-3 products that consumers can trust.
• IPA (International Probiotics Association) is an international organization with members equally divided between industry and academia and its goal is to provide a unique forum for the exchange of research and the latest breakthroughs in probiotic technology and new product development.
• NPA (Natural Products Association): NPA is the largest and oldest organization representing the entire natural products industry, with more than 2,000 members in all 50 states and internationally, accounting for over 10,000 retail, manufacturing, wholesale, and distribution locations of natural products.
• UNPA (United Natural Products Alliance ) is an association representing many leading dietary supplement, functional food, natural products and analytical and technology companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability.
  
  [Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]
  

The Heart of the Matter: Ingredients for Heart Health

By James J. Gormley


Heart health as a category has changed over the last 20 years. Years ago, health and nutrition magazines would tout the benefits of single vitamins, herbs or minerals: vitamins A, C and E; hawthorn, cayenne and garlic; and selenium. With the exception of hawthorn, these continue to be popular for cardiovascular health formulations.

In recent years, while other standalones that pack a punch for heart health have risen to greater prominence — coenzyme Q10, green coffee extract, fish oil, and recently magnesium — science has moved in the direction of much more sophisticated formulations, often featuring proprietary extracts or premium standalones with active ingredients produced via patented processes, a few examples of which are:

• AmealPeptide for heart health and blood pressure (milk-derived bioactive tripeptides that are extracted from milk proteins during a patented production process);   
• Blueberry flavonoids; 
• Citri-Z for heart health (proprietary blend that exclusively provides polymethoxylated flavones [PMF] and other bioflavonoids;     
• Curcumin for heart health; 
• Green coffee bean extracts for cholesterol and blood pressure;    
• Resveratrol for cholesterol;    
• Sytrinol for cholesterol (patented and proprietary formula derived from natural citrus and palm fruit extracts); and  
• Vitamin K2 (MK-7) (promotes heart health via help with arterial elasticity).

Part of the reason for this is that nutritional and botanical science has become more advanced, and part of the reason is that companies want to have unique formulations using one or more premium, patented ingredients or blends in order to differentiate their products from the rest of the ticker-boosting supplements that are out there.

That being said, promotion of heart-health products as part of a healthy lifestyle is becoming increasingly important to manufacturers and marketers, not only because that is more FDA/FTC friendly and more responsible for consumers, but because Americans are sick and tired of being told by Big Pharma to take pills to address health problems without addressing some of the most critical underlying causes of heart un-health: chronically poor food choices and sedentary ways.

Consumers are not thrilled with just taking more pills, whether they are supplements or pharmaceuticals, and they are not thrilled with the idea of having to devote many hours per week on heavy-duty exercise.

While anybody can capture a wallet, at least for a day, if marketers can encourage consumers to incorporate sensible supplementation into a by-and-large healthy diet with a reasonable amount of exercise, then these products (and their ingredients) will have a chance to truly capture hearts and minds, a concept Kevin Thomson rightly outlines in his book, Emotional Capital. Then you will have the consumer for a lifetime.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Premium Ingredients, Commodity Ingredients: No "Versus" Needed

By James J. Gormley



First off, what are “premium ingredients”? The term is so broadly used that the lines between intrinsic value and marketing speak do, at times become blurred.

Premium can mean any of these things, and more:

• A very pure or high quality source.
• An ingredient that has a “value-added” quality associated with it, such as a unique manufacturing, fermentation, purification or refining process, often protected by patents.
• Ingredient compounds protected by composition of matter patents or use patents for a given application.
• A unique delivery form, usually for enhanced absorption and bioavailability, ergo efficacy.
• A proprietary blend (although this is highly debatable as to whether proprietary makes it premium: see below.)

If you want to use or develop a premium nutritional ingredient, what considerations are involved?

Here are some bad reasons not to use or source a premium ingredient:

1. I just want to be able to charge more money and make better margins.
2. I only want to differentiate my finished product from competitors’ products.
3. I want to hide poor-quality or filler ingredients under a “proprietary blend” shield.

Here are some good reasons to use or source a premium ingredient:

1. I want to provide the most effective product I can, matching wherever possible the dosages and ingredient forms used in clinical studies.
2. I want to provide consumers with maximum value.
3. I want to utilize ingredients produced via technologies that developers have invested millions of dollars in.

As to the cost burden on consumers, in cases where there is a very high price point thanks to the use of premium ingredients, Michael Lelah, technical director for Bloomingdale, IL-based NOW Foods: says: “Yes, consumers ultimately decide, and we work hard to bridge the gap between commodity and premium ingredients for and on behalf of the consumer.”

Noting that NOW Foods, for example, tries to provide premium ingredients wherever possible, “There are times when we can’t justify the high price of a premium ingredient based on its increased benefit, and we are not prepared to pass this on to the consumer.”

As to the question of economic adulteration hiding behind the “proprietary blend” aegis, Lelah notes: “We believe in full transparency on our labels. All our nutritional ingredient amounts are declared on our labels and we in most cases declare the potency of the ingredient or key botanical marker, so the consumer knows what they are purchasing.”

I would imagine that other companies share NOW Foods’ way of approaching the question of premium versus commodity. In addition Federal cGMPs are starting to level the playing field between premium and commodity ingredients, as well.

So there you have it: when it makes sense, doesn’t create an unreasonable price point, and is utilized for the right reasons, premium ingredients can be a great choice. That being said, since the quality of U.S. commodity ingredients is rising every day, these ingredients can serve as the foundation for formulas, with premium ingredients added for specific applications.

 [Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Dan Fabricant's FDA Insights | Nutritional Outlook

In April, Daniel Fabricant, PhD, ended his three-year tenure as FDA’s Director of the Division of Dietary Supplement Programs. Fabricant has since returned to the Natural Products Association (NPA; Washington, DC), where, prior to joining FDA, he served as vice president of global government and scientific affairs. (FDA has named William Correll interim head of Dietary Supplement Programs. Correll hails from FDA’s Center for Food Safety and Applied Nutrition.)

Nutritional Outlook and industry members will be watching with interest to see how Fabricant’s inside experience at FDA with policy issues such as New Dietary Ingredients and Good Manufacturing Practices (GMPs) informs his work at NPA going forward. Upon Fabricant’s departure from the agency on April 18, 2014, FDA said: “Dr. Fabricant worked hard to strengthen the FDA dietary supplement program,” noting that, during his time there, the agency took several court enforcement actions and issued numerous warning letters to companies, including for adulteration, mislabeling, and GMP violations.

Now firmly back at NPA, this time as its CEO—succeeding John Shaw—Fabricant spoke to Nutritional Outlook’s James Gormley about a range of issues, from the future of the NPA, to emerging champions on Capitol Hill, GMPs, and more.

READ MORE: Dan Fabricant's FDA Insights | Nutritional Outlook

Shaking Up the Joint(s)

By James J. Gormley


The oldest Baby Boomers are now turning 68; the youngest are clocking in at 50. It’s clear: the U.S. has an aging population that is being confronted by all of the annoyances and challenges associated with senescence, including those associated with our joints.

With global bone and joint health market expected to reach $9 billion by 2017, according to Global Industry Analysts, U.S. ingredient sales of the granddaddies of joint health supplementation – glucosamine sulfate and chondroitin sulfate – were approximately $235 million (according to Synutra Ingredients’ website) for 2012.

While their widespread appeal in the mid-1990s led to initial sales that were like wildfire, there were certain challenges that beset these now-mainstay ingredients, especially chondroitin.

Initially, chondroitin was criticized by some since, (a) its molecules were said to be up to 300 times larger than those which make up glucosamine and so could not be absorbed, and (b) the first research on chondroitin was mainly made up of animals that had received it intravenously.

Lately, chondroitin adulteration has become a concern, yet fortunately some industry leaders, such as Weiguo Zhang, president of Synutra Ingredients and makers of Chondro Gold™, have called for much more stringent screening for impurities and adulterants, so it is hoped that an increased industry focus using combination test methods will expose suppliers engaging in economic adulteration.

Regardless, glucosamine and chondroitin are maturing as ingredients, and that is opening up some opportunities for other ingredients to gain a foothold in the joint health market.

MSM is one such ingredient. While not a new ingredient, MSM (such as Bergstrom Nutrition’s OptiMSM®) has been earning its position as one of the core ingredients included in popular combination joint-health formulas.

Another ingredient that has been around, yet which has been gaining traction, is collagen. With most of the early denatured-vs.-undenatured battles now behind us, InterHealth’s UC-II® and BioCell Collagen® have risen to the fore.

Omega-3s is a more recent entrant into the joint-health race, bringing with it widespread trust and recognized benefits in other health areas. Newer, cutting-edge ingredients have also gained popularity in the market, including ASU (Avocado/Soybean Unsaponifiables), Meriva-SR® curcumin from Thorne Research, ApresFLEX® from Laila Nutra, and 5-LOXIN™ from PLT Health Solutions.

While the aforementioned is not an exhaustive inventory of joint health’s shining lights, what the emergence of these newer ingredients demonstrates is what the consumer demands, the consumer will eventually get. End users have been looking for joint-support ingredients that don’t take months to kick in, efficacy-wise.

They want to see benefits in days, and that’s what some of the latest and most interesting finished products in this area are focused on today: real results, fast.

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Expo West 2014 Book Signings

Greetings, fellow Natural Products Industry members: 

Are you attending EXPO WEST this week?

Then I invite you to visit the Square One Publishers BOOTH #3356 on Friday or Saturday at 11:00 am to say "Hi!"

I will be signing autographs for my new book, Health at Gunpoint: The FDA’s Silent War Against Health Freedom.

WHAT: Book signings for James Gormley’s new book, Health at Gunpoint.

WHERE: Natural Products Expo West, Square One Publishers BOOTH #3356

WHEN: 
• Friday, March 7th, 11:00 am PST and Saturday, March 8th, 11:00 am PST.

You can order the book here.

I look forward to seeing many of my friends at the show!

On Menopause and Healthy Options, Part 2

By James J. Gormley

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

In 2006, I asked Jacob Teitelbaum, MD, whether menopause has been politicized.  “Not so much politicized as commercialized,” said Teitelbaum.

“There is big money to be made in supplying hormones to women in menopause. Unfortunately, natural hormones were not able to be patented, so the drug companies used Premarin, which is simply pregnant horse urine. The process for making this was patentable. Because of this, almost all marketing and research was done on Premarin. This was despite holistic doctors saying for over a decade that it was insane to use pregnant horse urine in human females.”

“Now that the research has shown HRT to potentially be dangerous, even though the research suggests that the bioidentical hormones are much safer and likely less noxious in terms of side effects; the drug companies are paying for a very expensive misinformation campaign to mislead the American public,” Teitelbaum added.

“Because bioidentical hormones present a major competition to them (they are cheaper, safer, and simply what your body is used to making), they are paying to make sure that people get confused so that they keep buying the expensive prescription forms of estrogen and progesterone. It reminds me of the old days when doctors were being paid to promote smoking and also to convince mothers that anyone who breast-fed was a primitive who was damaging her child.”

Fortunately, natural support abounds.

Many studies, for example, support the use of black cohosh for relieving menopausal symptoms. In fact, previous trials have shown black cohosh to be as effective as HRT for reducing hot flashes. St. John’s wort has been found to help relieve mild-to-moderate depression. In addition to black cohosh (Cimicifuga racemosa), other ingredients and products are also on the market, including: red clover; soy; chaste tree (Vitex); hops; dong quai; sage; essential fatty acids; and good, old-fashioned diet and exercise.

In line with this, on October 20th, 2012, the Natural Health Research Institute (NHRI) held its 8th Annual NHRI Scientific Symposium, entitled, “The Effectiveness of Natural Products for Women’s Health.”

The conference covered such topics as: the safety and efficacy record of black cohosh; the benefits of ginseng, kava, kudzu, maca, Pycnogenol, Sibiric rhubarb, St. John’s wort, valerian, omega-3 fats, and multi-ingredient combinations; detailed research into botanical alternatives to HRT, including promising studies on hops, red clover and (once again) black cohosh; and the importance of reducing body fat, in addition to supplementation with chromium, carb blockers, green tea extract, and conjugated linoleic acid.

So, all in all, there’s a lot of good research out there on safe options for female consumers (and those who love them) to empower themselves with safe, effective, science-backed supplements that will support, nurture, and cherish women on their health journeys.

On Menopause and Healthy Options, Part 1

By James J. Gormley

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Menopause is a life stage, just like puberty. In fact, in an interview I conducted in 1996 an editor for the American Botanical Council (ABC) put it this way:

“In puberty, a girl comes into her power as a woman. In menopause, a woman’s power deepens and strengthens. Menopause is a time for self-reflection — a time to evaluate where one has been, where one is presently, and where one wants to go. It is a time when women experience what Joseph Campbell calls their ‘function to be.’ ”

This initial time of change, referred to as peri-menopause, often kicks in several years before a woman’s last menstrual period. It lasts for one year after her last period, the point in time known as menopause. In fact, a full year without a period is needed before a woman can say she’s been “through menopause.”

The average age of menopause is 51.4, but before this, as mentioned above, usually in a woman’s 40s, changing levels of estrogen and progesterone often signal what are eventually considered symptoms of menopause. Women may have different signs or symptoms during menopause, mainly because estrogen is used by many parts of her body. That does not mean that she will have all, or even most, of them.

Moreover, signs that occur around the time of menopause may actually be a result of growing older, not changes in estrogen, such as: mood changes; hot flashes; osteoporosis; sleep problems; and heart disease.

In modern times, moderate-to-severe menopausal complaints were managed via conventional medicine with hormone replacement therapy (HRT). However, since a body of published research links the use of HRT with increased risks of breast cancer and heart disease, the search for safer alternatives has intensified.

In a 2004 review article by Taya McMillan, MPH, and Saralyn Mark, MD, in the Journal of the American Medical Women’s Association, “Forty percent of all menopausal women seek medical attention to alleviate symptoms of menopause.” They added that, “increasing evidence suggests that women are looking to complementary and alternative therapies for management and treatment of menopausal symptoms.”

“While many hormonal, physiological and digestive changes take place during menopause, perhaps the aspect most focused on by women and in medical literature is the symptom of hot flashes — for many women this symptom is one from which they simply want relief,” the ABC added.

Unfortunately not content to allow women to take charge of their own health without medicalizing their bodies, the FDA, at the behest of Big Pharma, on April 29, 1998 proposed re-classifying common conditions associated with natural states, such as hot flashes associated with menopause or premenstrual syndrome associated with the menstrual cycle, as “diseases” — a proposal which generated over 100,000 comments, most of which were in strong objection.

In Part 2, I’ll look at the aftermath and how the natural products industry can provide a safe and healthful solution.

Gormley NPI Consulting's new promo video clip!

Book Trailer for "Health at Gunpoint: The FDA's Silent War Against Health Freedom"

Health at Gunpoint: The FDA's Silent War Against Health-Freedom

By James J. Gormley

What forces and interests direct the Food and Drug Administration (FDA) and why is this out-of-control law enforcement agency working so hard to take dietary supplements out of our hands?

These are the central questions explored in Health at Gunpoint: The FDA's Silent War Against Health Freedom, what I hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.

The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.

In Health at Gunpoint, I present a history of both the natural foods movement and of this over-reaching Federal agency and examine how the agency has changed over the years. I then look at the FDA's most controversial decisions and the troubling reasons behind them.

Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered food not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?

Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.

In many European countries, nutritional supplements are now available by prescription only. If you don’t think harmonization-friendly, anti-consumer, restrictions can be put in place here, you may be in for a rude awakening.

Health at Gunpoint will help prepare you for the coming fight.

Children Are Not Little Adults

By James J. Gormley
Courtesy of the SupplySide Community

One of my back-to-school memories in the late-1960s and early 1970s was going to the five-and-dime with my mother and choosing brand-new marble “composition pads” and #2 pencils. 

A 1970s-era ad ... the thinking has changed since then.

Although I preferred Jules Verne to geometry --- and really “digged” my summer vacations --- I was still psyched at the beginning of each new school year. I think it had something to do with the seemingly infinite possibilities for learning and success, fun and friendship. A clean slate (or blackboard).

Today, not every child has it as seemingly worry-free as that, unfortunately. In 2007, 5.4 million American children aged four to 17 were reported to have attention deficit hyperactivity disorder (ADHD) and, of these, over half of that number were being medicated for this disorder. In addition to that, autism afflicts more than 2 million people, the incidence of which increased 172 percent in the 1990s.

Artificial additives are linked to ADHD and, in addition, one of many contributing factors to this developmental disability is believed to be mercury exposure, including the historical use of thimerosal in vaccines.

According to Robert F. Kennedy, Jr., in a 2005 Rolling Stone article, “The FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen.” In 2012, thimerosal is still being used in vaccines.

Kennedy added: “If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children [with thimerosal], their actions arguably constitute one of the biggest scandals in the annals of American medicine.”

And as if things were not challenging enough for children without even considering exposure to toxins, the Federal Interagency Forum on Child and Family Statistics noted that the percentage of overweight children aged six to 17 years between 1976-1980 and 2003-2004 has gone from 5.7 to nearly 17 percent; in addition, 2 million adolescents (or 1 in 6 overweight adolescents) aged 12 to 19 have pre-diabetes, according to the American Diabetes Association.

There are, however, some indications of improvement in the lives of American kids. The percentage of children living in households classified as “food insecure” has gone down and educational attainment in high school is improving, noted the Forum.

One thing much better today for kids is the variety of dietary supplement options, from multivitamins to immune-boosters to omega-3s and more. Not only is the selection better in health-food stores but so is the manufacturers’ focus on including natural-source ingredients and excluding what I would have called “yucky” but my kids would probably call “nasty” artificial colors, flavors, binders, excipients and preservatives.

As customers visit retailers looking for healthy snacks, yogurt smoothies and kids’ vitamins, retailers can serve as an island refuge in a sometimes scary ocean of supermarkets and mass market behemoths.

Armed with good information, high-quality products and trustworthy guidance, you can help your end-user customers genuinely help their children.

In the meantime, the kids can get back to perhaps avoiding geometry and reading Jules Verne’s Journey to the Centre of the Earth, er … or would that be The Hunger Games?

Note: The title for this piece came from an ad I found (manufacturer name and ad copy cropped out) from July 23rd, 1978, subtitled: “Because Children Are Little Adults.” Of course, kids have different metabolisms and nutritional needs over and above the fact that they may be 25 to 50% less heavy than an adult, but this was the thinking in the late-1970s!

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!

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.

Announcement: Cost Effectiveness and Safety of Dietary Supplements Symposium

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’!

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.
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