Newsflash: Dietary Supplements Are Safe and Beneficial: Prescription Drugs Are Not!

By James J. Gormley

On August 23^rd, Newsday, a New York City newspaper ranked by Dr. Tim Groseclose as one of the top 61 most “liberal” local newspapers in the U.S. ran an article amazingly entitled, “FDA Official: 70% of Supplement Companies Violate Agency Rules.”

By “liberal” Groseclose did not mean the classical liberalism of a Thomas Jefferson or an Abraham Lincoln but the “big government,” nanny-state modern liberalism ushered in by Woodrow Wilson and expanded upon after 1921.

So perhaps we should not be completely surprised that any liberal paper would slant its coverage to support the unaccountable bureaucratic leviathan than the FDA is today ─ but, sadly, this does not serve the paper’s roughly 378,000 daily readers, readers who are, in large part, also consumers of dietary supplements ─ or at least they were before the above-cited “the sky is falling” article.

Dietary Supplements: The Real Story

Good Manufacturing Practices (GMPs) for dietary supplements are not new. The federal Current Good Manufacturing Practices for dietary supplements (21 CFR Part 111) were issued six years ago, and the Natural Products Association (NPA) rolled out its own voluntary GMP-certification program in 1999.

Contrary to the horror show of allegedly widespread incompetence, contamination and criminal negligence portrayed by the article, dietary supplements (a class of food products) are even more regulated than is food. According to whom, you ask?

How about the country’s most respected expert on food and drug law, attorney Peter Barton Hutt, who served as Chief Counsel for the FDA from 1971 to 1975, has taught food and drug law at Harvard for over 20 years, is the co-author of Food and Drug Law: Cases and Materials (Foundation Press, 3^rd edition 2007), and has published more than 175 book chapters and articles on food and drug law and also on health policy?

“The [Food Drug and Cosmetic Act], as amended by DSHEA and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, provides somewhat greater FDA regulatory authority over dietary supplements than over conventional food,” noted Hutt in a white paper commissioned by the Council for Responsible Nutrition (CRN) entitled FDA Statutory Authority to Regulate the Safety of Dietary Supplements (2^nd edition, 2011).

Safety: The Facts

According to the Newsday article, approximately 6,300 adverse event reports were submitted for dietary supplements from 2008 to 2012, a 4-year period. 

Not even considering the fact that most of these reports were likely inaccurately linked to supplements when other factors were the more probable causes, in the same period Pharmaceutical Commerce reports that were approximately 3,260,000 adverse events reported for pharmaceutical drugs!

I don’t recall seeing this stark comparison in the newspaper article.

The FDA official quoted in the story, Daniel Fabricant, Ph.D., was formerly the science head for the NPA, and was a staunch defender of natural products until he became its chief critic at the FDA.

On August 26^th, John Spilateri Shaw, the CEO of Dr. Fabricant’s alma mater, the NPA, noted in an open letter to Newsday that “industry members strongly support providing additional resources for the FDA to keep illegal products disguised as legitimate supplements off the market.”

The vast majority of “supplements are beneficial, and millions of Americans depend on them each day,” Shaw added in his letter. “Your readers should continue to use these products that safely and positively influence their lives on a daily basis.”

Prescription and OTC Drugs: Safety? Not So Much

And what about the FDA takeover of three drug plants in 2011 following “shocking conditions” at the plants where one of the most popular line of over-the-counter (OTC) pain relievers (rhymes with “i-lenol”) were manufactured. "This inspection report is pretty close to being the worst I've seen,” according to David Lebo, a professor of pharmaceutical manufacturing at Temple University in Philadelphia, in an interview for CNNMoney.

The inspections reportedly uncovered safety and quality violations in every system, control and process, from bacterial contamination, to filthy manufacturing and storage conditions, to super-potent levels of pain relievers in batches of the infant pain-relief formula.

Didn’t see much media coverage of this, did you? I only noticed an obvious absence of the products from store shelves, and that was my first tip-off.

Hutt added: “DSHEA provides greater FDA scrutiny of new dietary ingredients than exists for new conventional food ingredients and adds new safety enforcement authority for all dietary supplements that extends beyond the FDA authority applicable to conventional food.”

Adulterated Supplements Are Illegal Drugs, Not Supplements

As to cases of deliberate adulteration of dietary supplements, if the ingredients were anabolic steroids, the product in question would then be an illegal drug ─ not a supplement ─ and it is subject to action by the U.S. Drug Enforcement Administration (DEA). I have been calling for the DEA to step up to the plate since 2010.

The same with deliberate contamination with weight-loss, sleep aid, or sexual health drugs, the rare number of cases of this type of adulteration also renders this type of hybrid product an illegal drug; it is no longer a dietary supplement product or issue.

As to even more rare cases of legitimate manufacturers who unwittingly receive and use shoddy, contaminated or adulterated raw materials due to falsified documentation and certifications, it is the manufacturer’s responsibility to ensure the purity and safety of the ingredients it uses, and there are multiple mechanisms in place to quarantine, test and verify ingredients before they are included in finished dietary supplement products.

Peter Barton Hutt's Takeaway on Supplement (Hyper) Regulation

“DSHEA adds three additional procedural safeguards for dietary supplement court actions to assure that FDA will act fairly and equitably in its enforcement of safety requirements, but does not substantially change the requirements applicable to court actions involving conventional food,” noted Hutt.

According to him, “The Dietary Supplement and Nonprescription Drug Consumer Protection Act expands FDA’s regulatory authority over dietary supplements by adding postmarket reporting and recordkeeping requirements that are more stringent than those that apply to conventional food.”

“Thus, in many ways, the current food safety provisions of the [Food Drug and Cosmetic Act] provide FDA with greater substantive authority over dietary supplements than they provide for conventional food, and the modest procedural changes in the court enforcement requirements have had no impact thus far and are unlikely to have a significant impact in the future,” Hutt concluded.

To counter the article’s misleading timeline with one that more accurately reflects the safety and consumer protections surrounding dietary supplements, I offer, by way of conclusion,  this one adapted from Peter Hutt's white paper:

• 1994: Congress enacted the Dietary Supplement Health and Education Act (DSHEA) to to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary ingredients.
• 2002: Congress enacted the Public Health Security and Bioterrorism Preparedness and Response to provide additional authority to assure the safety of the food supply. In 2006, Congress enacted the Dietary Supplement and Nonprescription Drug Consumer Protection Act to require mandatory adverse event reporting systems for dietary supplements.
• 2007: Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA) to prohibit the addition of drugs or biologics to food and to authorize the creation of a “reportable food registry” to collect information about articles of food that may pose serious health risks.
• 2011: Congress enacted the FDA Food Safety Modernization Act (FSMA) to improve FDA’s capacity to prevent, detect, and respond to food safety problems.

New York City: A Nanny State of Mind?

By James J. Gormley

If New York City’s Mayor Bloomberg has his way, many more people will be passing out in 100-plus-degree stairwells, since his latest initiative promotes taking the stairs over riding elevators in New York City buildings.

Mind you, while taking the stairs would theoretically be much better for cardiovascular health if air-conditioned or well-ventilated, well-lit, and safe, the problem is that, in New York City at least, many of them are not.

In fact, at the July 17^th press conference announcing this new initiative, New York City’s own health commissioner, Thomas Farley, admitted: “In too many buildings, the stairs are hard to find, kept locked, armed with alarms, or dark and windowless–making people afraid to use them.”

Aside from this, with the average high-rise height of 12-to-40 floors and the average apartment-building height of six stories---and considering that these dark, un-ventilated passageways can reach temperatures well over 100 degrees in the summer---it doesn’t help things when we consider that they are also dangerous.

As Donnel Baird noted in a July edition of the New York Times, “If cops are on the street, crime moves into the stairwells.”

Now while Bloomberg in not forcing people to take the stairs yet, just give him time.

Look at his recent herculean efforts to impose a ban on sugary drinks over 16 ounces (which doesn’t apply to some convenience stores or all supermarkets, and people can just buy extra drinks anyway).

On the website, Above the Law (abovethelaw.com), back on March 11, 2013, Elie Mystal wrote: “In case you haven’t been following along with developments inside Mike Bloomberg’s […] nanny state, last year our elected tyrant outlawed the sale of soda in sizes over 16 ounces at movie theaters and other public places. The mayor felt that nobody needed more than 16 ounces of soda in one sitting, notwithstanding the fact that nobody asked him what my mother thinks.”

Fortunately New York Supreme Court Judge Milton Tingling overturned the ban in March, stating  that “[The city] is enjoined and permanently restrained from implementing or enforcing the new regulations.” He added: “[The regulations are] fraught with arbitrary and capricious consequences. The simple reading of the rule leads to the earlier acknowledged uneven enforcement even within a particular city block, much less the city as a whole. The loopholes in this rule effectively defeat the stated purpose of the rule.”

In other words, even this were not an outrageous violation of freedom of choice and consumer rights, this law would still be a complete joke.

He specifically wrote that “to accept [Mayor Bloomberg’s] interpretation of the authority granted to the Board by the New York City Charter would leave its authority to define, create, mandate and enforce limited only by its own imagination.”

The judge went on to note that the Portion Cap Rule, if upheld, “would create an administrative Leviathan and violate the separation of powers doctrine. The Rule would not only violate the separation of powers doctrine, it would eviscerate it. Such evisceration has the potential to be more troubling than sugar sweetened beverages.”

As Mystal correctly opines, “I’ve been living under Bloomberg for so long I forgot that ‘so let it be written, so let it be done’ is not a sufficient state interest for the curtailing of individual liberties.”

As Mystal adds, you cannot legislate good health or portion control, and I agree with him and others that it is the height of arrogance to presume to do so.

That is not stopping Bloomberg spending millions of our-tax-dollar-paid NYC Corporation Counsel attorneys from pursuing this mad quest to the NY State appeals court.

In a June 6^th, 2013 Associated Press article published on the Huffington Post, David B. Caruso wrote: “Justice David Friedman said the city appeared to be asking for unprecedented authority to regulate all sorts of portion sizes, including ‘the number of doughnuts a person could eat, the number of scoops of ice cream’ and number of servings of fried chicken.”

Unlikely as it is for me to agree with the American Beverage Association, I do in this case. According to Caruso’s article, Richard Bress, an attorney for the association, “challenged the regulation acknowledged that too much sugar can be unhealthy, but he told the court the regulation was ‘a breathtaking example of agency overreach.’ "

Bress correctly told Caruso that the city’s proposal appeared to be based more on politics than science. He pointed out, for example, that no limits would be set for calorie-gargantuan milk shakes.

Meanwhile, the appeals court has not yet set a date for its decision.

Gormley Take-Away: Whether it is the FDA saying people shouldn’t have access to raw milk (because they don’t like it, apparently), or California making almost every product or material in the state labeled with a nonsensical Prop 65 warning that “this might cause cancer,” or whether it is bureaucrats like Michael Bloomberg wagging his finger at us and telling us he will decide what’s best for us and any semblance of separation of powers or consumer rights be damned, common sense cannot be regulated and consumer choice---and citizens’ rights---must be protected at all cost. What if early American decided it didn’t like religious freedom and preferred living under the domination of oppressive rule from afar? I probably wouldn’t have the freedom to question intolerably bad policies and laws and regulations like these, and you wouldn’t have the freedom to read this blog and any other articles or books questioning them either. My suggestion: use your power at the voting booth to kick out those who would create or perpetuate Nanny State, Big Government regimes and elect those who will fight for liberty, justice and health-freedom.

James Gormley's "Health at Gunpoint"; First Video Narration from OneNinth Media

OneNinth Media has just released the first in a series of video narrations of select snippets from my new book, Health at Gunpoint: The FDA's Silent War Against Health Freedom.

You can find the book here:

Publishers Weekly Announces Gormley Segment on The Brett Winterble Show!

My thanks to Publishers Weekly for announcing my appearance on tonight's The Brett Winterble Show on SiriusXM's America's Talk Channel 166 between 9:00 pm and 12:00 am EST.

And my thanks to host Brett Winterble for asking some great questions!!

Health at Gunpoint: Expo West Book Signing Coming Up!

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 pregnancy 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.

Far from being a “conspiracy theory” book, Health at Gunpoint looks at how Americans made up their minds to develop a more food-secure, cleaner, and healthier world and how they had to fight vested interests and the FDA to create that world for themselves---and for us.

It informs, blows holes in myths, and hopefully will also inspire a brand new generation of health-freedom advocates to fight for their rights!

Note: If you are attending the 2013 Natural Products Expo West trade show in Anaheim, California, please stop by the Health at Gunpoint book signing at the Square One Publishers' Booth No. 804 on Saturday, March 9th, at 12:00 pm!

What's the real take-home message of a new, negative Department of Health and Human Services report regarding dietary supplements?

By James J. Gormley

On October 2nd, 2012, Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS), issued two reports regarding dietary supplements.

The first report, regarded as the more serious of the two, entitled “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” captured immediate public attention and could have, say some, lasting negative impact on the dietary supplement industry. But are the report’s allegations true ... or fair?

The Report: What Does It Say Its Says?
With its first report on structure-function claims, HHS purported to assess industry compliance with structure-function claim requirements. As such, HHS’s Office of the Inspector General (OIG) purchased 127 dietary supplement products—specifically, immune support and weight-loss supplements—on the open market to examine their structure-function claims.

In total, OIG purchased 67 immune support supplements and 60 weight-loss supplements, 67 of which were from Internet sites and 60 of which were from retail stores. Aside from other alleged problems, the HHS report said that 20 percent of the products displayed prohibited disease claims.

As to what stimulated the HHS OIG to conduct the review, the structure-function report’s preamble only states that the investigation was a response to inquiries from both the Government Accountability Office (GAO) and “public interest groups.”

A Cherry-Picked Sample?
A number of industry organizations and consumer advocates challenged whether such a small sampling of products could be regarded as representative of the dietary supplement industry at large, including the industry’s many responsible companies.

As Washington, D.C.-based Natural Products Association (NPA) executive director and CEO John Shaw, said in an an interview with me for Nutritional Outlook magazine, “The OIG only checked 127 supplements out of more than 29,000 on the market. The report itself says that the results cannot be generalized across the entire industry. Therefore, a small sampling of supplements should not be used as a smear against a legitimate industry that cares about the safety and health of consumers.”

Others expressed concern regarding the OIG’s sampling methods, expressing doubt that 20 percent of randomly chosen products would have had disease claims.

Justin J. Prochnow, a Denver-based attorney with Greenberg Traurig, discussed the sampling question. “My inclination would be to believe that the majority of the products cited in the report said to be marketed with alleged disease claims were being marketed online from websites without an established reputation. It has been my experience that ‘brick and mortar’ stores, as well as reputable online stores, are putting products through a pretty comprehensive label and claims review process before allowing them to be sold.”

“I would be very surprised if many of the products used as the basis for the report were purchased at well-known stores or from reputable online retailers,” he noted. In addition, industry members criticized the HHS report for intentionally not identifying the questionable products.

"They don’t identify the companies, so you don’t know which ones were in the 20 percent [of questionable products],” said Steve Mister, president and CEO of the Washington, DC-based Council for Responsible Nutrition in an interview with me for Nutritional Outlook. “You don’t know if they were all fringe companies on the edges of the internet that maybe collectively had sales of a million dollars, and whether everybody else, the ones that got it right, were the NBTYs and the Pharmavites.”

In an attempt to tackle this question, on behalf of Nutritional Outlook magazine I submitted a Freedom of Information Act (FOIA) request to the IG’s office asking them to reveal the names and manufacturers of the products with questionable claims, in addition to information on what websites the products were purchased from.

In addition, some take issue with the fact that the OIG’s office asked companies to voluntarily send substantiation data, but then in the reports criticized the submissions for not also containing negative data—a criticism that Mister dismisses.

“If the OIG wrote to me in a voluntary survey and asked for my substantiation, why would I ever send them anything that was negative?” Mister said. “Even if I had [negative substantiation] and I gave it to FDA, why would I send it to the OIG? I wouldn’t. However, the OIG says, ‘Well, you didn’t meet all of [our] criteria because you didn’t disclose studies that went the other way.’ But did OIG ask those companies to do so? No. Instead, OIG said, ‘Send us your substantiation for your product,’ so naturally a company is only going to send OIG the substantiation that’s supportive.”

What Does It Really Say
Since Inspectors General (regardless of department of agency) are almost always charged with primarily investigating internal fraud, waste, abuse and mis-management, what did the IG find regarding how the FDA manages dietary supplements?

When the FDA was asked by the IG to produce substantiation documents that had been previously submitted by companies, the FDA had no idea where to find them and, indeed, had no system in place to record, archive, track and retrieve submission documents that its own regulations require!

Here’s what the IG wrote:

“FDA could retrieve notification letters for only 21 of 127 supplements in our sample. FDA’s failure to locate notification letters raises questions about its ability to adequately monitor and enforce manufacturers’ compliance with structure/function claim requirements” [emphasis mine].

In addition, as mentioned above, the IG wrote that the FDA “lacks a reliable tracking system for notification letters.” The report said:

“FDA saves letters in a PDF format that cannot be searched by keyword. As a result, FDA could not locate letters for our sampled supplements using the product name or the manufacturer’s name. As of December 2011, FDA staff told us the agency had letters waiting to be scanned that dated back almost a year. FDA files the paper copies of notification letters chronologically. Therefore, FDA would have had to search thousands of files by hand to locate letters for our sample of supplements” [emphasis mine].

So, as the saying goes, the elephant in the room was the obviously horrible mismanagement and disorganization (perhaps incompetence) of an agency, in this case the FDA, an agency that the IG is suggesting be given even more power and responsibility over supplements despite the fact that the agency has proven that it cannot even handle the most basic of its existing responsibilities. This serious indictment of the FDA was half-buried in the report itself and completely ignored by the mainstream media.

Future Effects?
Despite the serious flaws in the report, to the average consumer the HHS reports have the potential to paint the broad supplements industry in a bad light, indeed. The media was quick to gravitate to this. Among the alarmist headlines following the reports’ release: Huffington Post’s “Dietary supplements illegally labeled: Dozens make false claims, report says;” CBS News’ “Study: Some dietary supplement labels illegal;” and from that most balanced of news sources, the American Medical Association (AMedNews.com), “Dietary supplements often lack reliable evidence to support health claims.”

As largely unimportant as the report might seem since it is a small study with limited applicability and potentially flawed, both industry and consumer groups view it as likely ammo the dietary supplement industry’s foes in Congress could try to use in support of efforts to expand FDA’s authority over dietary supplements, which we’ve shown would be disastrous for several reasons.

“I’m particularly concerned about [one] recommendation [in particular], because I think this is the most damning line in the report, which says, ‘FDA could seek legislation requiring approval for all structure-function claims in the labeling of dietary supplements,’” added Mister. He noted, “I don’t think FDA has a right to do that under the law, and certainly even if it had a right to do that under the Constitution, obviously [the dietary supplements industry] would fight that tooth and nail in Congress.”

Mister speculated how the FDA might use the first report for a longer-term plan that might include the revocation of some, or many, structure-function claims, with the agency reasoning, “Well, you know what? These have really become de facto disease claims,” he said.

“This dubious document, which we believe will serve as an advocacy [tool] for greater FDA regulation of free speech, is a far cry from the OIG’s stated mission, which is to audit and investigate HHS programs to prevent and detect fraud and abuse,” added Gretchen DuBeau from the Washington, DC-based Alliance for Natural Health.

DuBeau summed it up in this way: “FDA chooses not to provide or improve guidance for the industry. [When] a few bad apples exploit the regulatory uncertainty, those bad apples are then used by advocacy groups and members of Congress to reduce our access to all supplements.”

Editor's note: The Gormley Files is very grateful to Nutritional Outlook magazine for permitting some text from the upcoming November 2012 "Global Regulations" story to be adapted for use here.

The FDA's Record on Slimming Products: Weighing In

By James J. Gormley

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

Considering the U.S. Food and Drug Administration’s (FDA) record as a flibbertigibbet on weight-loss product enforcement (dragging its feet on ephedrine for years while green-lighting dangerous weight-loss drugs on a dime) — and in light of the FTC’s record of multimillion dollar fines and orders against makers of supplement weight-loss products — for any company to enter this arena, either with a proprietary slimming ingredient or with a finished product, it is a minefield out there. Witness warning letters sent by the FDA to makers of HCG diet products.

Despite (or due to) the aforementioned spotty record, it is hard to fathom an FDA agency advisory committee’s recent green light for a combo of phentermine and topiramate (Qnexa), a diet pill that has, according to the Alliance for Natural Health, “documented risks of causing birth defects and heart problems.”

Abdominal Cramps Anyone?

On January 24, 1996, the FDA approved the synthetic fat-substitute, olestra, for use in snacks. But would you want a product with this warning? “This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients.”

Anal leakage is most certainly not on my “hit parade” of things I am looking for in a snack beverage, or any product for that matter!

According to an update by Center for Science in the Public Interest (CSPI), “Olestra is a moribund, if not totally dead, product.” No surprise there.

A few years later, in March 1999, consumer and industry advocates successfully testified on Capitol Hill to oppose the FDA’s proposal to redefine disease to include life stages and normal discomforts, such as pregnancy, aging, menopause and headache.

The FTC Steps Into the Breach

On November 9, 2004, the Federal Trade Commission (FTC) launched “Operation Big Fat Lie,” what it billed as “a nation-wide law enforcement sweep against […] companies making false weight-loss claims in national advertisements.”

According to the FTC at the time: “Operation Big Fat Lie is the latest in the Commission’s efforts to: stop deceptive advertising and provide refunds to consumers harmed by unscrupulous weight-loss advertisers; encourage media outlets not to carry advertisements containing bogus weight-loss claims; and educate consumers to be on their guard against companies promising miraculous weight loss without diet or exercise.”

Agreed, although the FDA’s track record on weight-loss products in all categories has not helped American consumers very much, either.

Alley-oop!

In 2006, GSK applied to get its drug (orlistat) — which was said, at the time, by the group Public Citizen, to have a history of side effects and gastrointestinal problems — re-classified as an OTC weight loss drug called alli™.

Shades of olestra, Public Citizen’s objections cited such embarrassing product usage problems as anal leakage and such serious problems as pre-cancerous lesions. On February 7, 2007, the FDA dismissed the group’s well -argued petition, saying that the product label already warns people about the messy bowel problems.

As to those pesky pre-cancerous cellular changes allegedly caused by the drug (called “aberrant crypt foci”), the FDA said they aren’t of “clinical significance.”

Interesting, because according to the NIH National Cancer Institute, aberrant crypt foci represent “one of the earliest changes that can be seen in the colon that may lead to cancer.”

But, then again, FDA’s approvals were being called into question — institutional arrogance can’t allow that — and a powerful drug maker’s products were also being questioned.

Still dead set on the weight-loss market, on April 17, 2008, GSK and groups it funds submitted a Citizen Petition (FDA-2008-P-0248-0001) calling for the FDA to reclassify all weight loss support claims for dietary supplements as disease claims.

GSK was joined in this petition by the American Dietetic Association, the Obesity Society, and Shaping America’s Health. The organizations’ signatories included a lobbyist, a person who helped get obesity classified as a disease and a fundraising guru.

In the petition’s summary, GSK and its co-petitioners stated: “Moreover, the actions requested in this petition would help address concerns about the safety of weight loss supplements” and “By requiring weight-loss supplements to undergo pre-market review, FDA would shift the burden to manufacturers to show that their products are safe.”

What about the potential safety problems related to GSK’s alli? This product went through both a prescription drug and (an albeit cursory) OTC safety review process and it still has a number of reported concerns associated with it.

Takeaway: Allowing questionable weight-loss drugs and prohibiting legitimate claims for dietary supplements that assist people in achieving body composition and weight-loss goals provides Big Pharma an El Dorado, like the legendary lost city of gold, and cheats consumers out of safe, effective products while exposing them to unwarranted risk.

Promo Video 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.

The FDA's DMAA Gamble

By James J. Gormley
Senior Policy Advisor, Citizens for Health

Courtesy of the SupplySide Community

On April 24^th, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 companies cautioning them, in the strictest possible terms, that their DMAA (1,3 Dimethylamylamine)-containing products may be considered new dietary ingredients for which notifications have not been submitted and, so, would be adulterated products in violation of law and subject to seizure.

And, oh, by the way, since DMAA is a synthetic version of what may or may not be a constituent in geranium, it could not even be an NDI if it wanted to be, according to the FDA.

The FDA is resting its very, very shaky case on a false premise, or misguided hope, that DMAA is not found in geranium and that synthetic analogues of naturally occurring consumables would never qualify as a dietary ingredient. This willful misinterpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) comes directly from the FDA’s NDI Draft Guidance.

For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated.

Most dietary supplements on the market today contain synthetic analogues of naturally occurring natural ingredients, including vitamin C, alpha lipoic acid, and various amino acids.

In truth, DMAA is a constituent of the geranium (Pelargonium graveolens) plant, having been identified in the oil obtained from the steam distillation of the stems and leaves. This DMAA-containing plant has been used for centuries as a food item (e.g., leaves are infused for teas and added to desserts and confections, flowers are used in salads, while the oil has been used as a flavoring agent). In fact, the geranium plant and its oil are generally recognized as safe (GRAS). In terms of safety, GNC, for example, has sold 440 million servings of DMAA since 2007, with only one reported adverse event.

The FDA is following on the heels of the Defense Logistics Agency, which took products containing DMAA off military base shelves earlier this year based on two cases of death anecdotally linked to DMAA—despite the fact that the Pentagon has acknowledged no link between DMAA and the soldiers’ deaths.

On September 6^th, 2011, Barry Lynch from Cantox Health Sciences International issued an open memo in which he stated that not only do published data already exist (Ping et al., 1996) confirming that DMAA does occur in geranium oil, but also that USPlabs (the maker of Jack3d) has obtained new data “from two independent and highly respected analytical chemistry laboratories, utilizing advanced validated […] instrumentation and methods, [that] corroborate the original data published by Ping et al., and further demonstrate the occurrence of DMAA in the geranium plant […] and its edible oil.”

To be clear, the FDA is outrageously overstepping its bounds by using (although not overtly citing) non-binding opinion from a draft guidance document in Warning Letters in order to not only scare the named companies from using DMAA any longer but to also cause a widespread chilling effect in the marketplace where gun-shy companies preemptively pull an ingredient that is attracting the FDA’s attention rather than go to bat for it or join with other companies that are.

We see this happening already. Even companies that did not receive a Warning Letter are reformulating or have already reformulated their products into non-DMAA alternatives.

This is exactly what the FDA wants. Use inexpensive Warning Letters (as opposed to attempting to drag companies into Federal Court or to actually prove anything, which it cannot) to frighten the marketplace into “complying” with a version of the law that the Agency wished were in place but is not.

But no matter, if the industry decides that is much easier, and safer, to just sacrifice DMAA to avoid nasty letters from the FDA and to shield itself from frivolous class-action lawsuits citing non-binding Warning Letters, then it will have conceded defeat without a live bullet having even been fired.

And this is not to be critical of industry firms either, which honestly need to balance legal and regulatory exposure with the perceived or actual value of keeping a now-controversial ingredient in products, not to even mention public companies’ shareholder concerns and jittery insurance company worries.

That being said, the whole ugly mess reminds me of the early years in our current millennium when ephedra’s neck was on the proverbial chopping block. Many of us testified on behalf of this wonderful master botanical and tried to enlist the aid of an ephedra council from which the members had fled as if from a burning house---the San Diego ephedrine scandal did not help things, to put it mildly.

Now we have an ingredient on the chopping block.

It may not be a master herb with thousands of years of traditional use. It is not a full-spectrum botanical. And it has been included in some products whose marketing is not what we would hold up as a shining example of advertising probity and conservatism. But it does represent a line in the sand drawn by the FDA.

If we were to fully cave on DMAA, the FDA will use this as precedent for establishing a beach head on the shore of “nothing synthetic can be an NDI,” and then where will we be and what will we have gained---or lost?

Going GE-Free and GMO-Free Labeling: The Right Way to Do It

By James J. Gormley

On March 12^th, 55 members of Congress submitted a joint letter to the U.S. Food and Drug Administration (FDA) in support of a legal petition backed by over 400 organizations and businesses calling on the agency “to protect  consumer  rights  and prevent consumer  deception by requiring the labeling of genetically engineered  [GE] foods.”

With over 500 organizations and companies now behind it and over 1 million petition signatures submitted to the FDA before the FDA’s comment deadline, it is clear that there is a renewed groundswell of consumer support for the labeling of GE (or genetically modified, GM) foods and ingredients.

On Tuesday, March 27^th, the FDA responded to the petition by saying it had not yet made a decision and needs more time; it also only recognized 394 signatures rather than 1 million, an anomaly due to the FDA’s peculiar way of handling and recording petition drives and form letters.

Nevertheless, 17 states have reportedly introduced GE-labeling legislation, with bills in Connecticut and Vermont currently standing the best chance of passing. Meanwhile, Californians are being mobilized to secure a place for a mandatory GE-labeling ballot initiative in time for the November general election.

Let's Be Careful What We Ask For

Do we remember the last time there was a mandatory labeling initiative in the Golden State? The year was 1986. That was when “The Safe Drinking Water and Toxic Enforcement Act” was passed into law via a direct voter initiative.

Prop 65, a well-intended yet disastrously misguided law that should instead be called the “Private Attorney Enrichment Via Straw Man Plaintiffs Act,” has done little to protect consumers but has done much to hurt businesses operating in or selling into California, including dietary supplement companies.

In addition to providing a disgraceful “gravy train” for unscrupulous consumers and avaricious attorneys, it does nothing to truly help consumers as its labeling requirements make it seem that virtually every product a consumer sees, walks on, sits on, wears, consumes or somehow comes in contact with is carcinogenic. It becomes the state government version of a student with bad study habits who yellow-highlights 99 percent of the text in a chapter as a test preparation, which of course is the same as not highlighting anything.

Let's Think It Through First

So the cautionary here is: We must be careful what we ask for, because if we don’t think through the proposed pieces of legislation downstream to the level of roll-out, regulation and enforcement, and how they will affect the labeling of food supplements and other functional or fortified consumables, then we might well be in for a surprise.

For example, it is known that between 65 to 72 percent of corn in the U.S. in GE (some estimates have this as 88 percent), in addition to 94 percent of soy, 95 percent of sugar beets and over 90 percent of canola (rapeseed). Not only that, but 75 percent of wheat farmers are interested in “going GE” and over 30 percent of riceland has already been contaminated by herbicide-resistant GE rice.

In fact, on a global scale, over the past 15 years more than 2.47 million acres (an area larger than China and the U.S. combined) have been planted with GE crops.

“By anyone’s reckoning, it’s a fast-moving train,” wrote Cookson Beecher of Food Safety News on January 27^th. “Biotech crop cultivation jumped 87-fold between 1996 and 2010, making genetically engineered crops the fastest-adopted crop technology in the history of modern agriculture.”

Let's Support Non-GE From The Ground Up

So, in a practical sense, if we don’t support market changes from the ground up, we may hurt some of the same health-food companies we are trying to help. For example, if only 6 percent of soy acreage is non-GE, there may not be a sufficient supply to meet the demand of consumers who are looking for GMO-free soy protein isolate powder at their local store.

In addition to issues of a nearly non-existent supply, there are also important price considerations for consumers and stakeholders to consider. According to chef Eric Ripert as quoted by FoodNavigator-USA.com, if people want to solely eat non-GMO, “they need to increase their food budgets---and prioritize their spending on food over luxuries, such as the latest iPhone.” He also suggested that people could consume smaller portions.

So if we are going to encourage that producers shun 65 to 95 percent of ingredients on the market, what mechanisms are we going to campaign for to increase investment in sustainable, GMO-free cropland? It takes over 3 years to convert from non-organic to organic, and organic farms do not currently receive USDA subsidies. That needs to change.

We need to generate the political will in Washington and Maryland to make sure that attractive subsidies, interest-free loans, equipment discounts and tax breaks are offered to farmers for converting their farms to organic and for new, family farmers to get started. This must be supported by consumers and by the food and food supplement producers who can, and should, commit to sourcing their ingredients with suppliers who work with these family farms.

And consumers must be made aware of the importance of purchasing products made with these ingredients while keeping in mind that it will take some years for the market and the products to catch up to the demand, and to be patient with companies who are committed to increasing their percentage of non-GE ingredients each year in line with the ever-increasing supply of those ingredients.

Gormley Files Take-Away: If we support the market of and for non-GMO this way, organically if you will, we will reduce or eliminate the economic incentives for agri-business to take over the last-remaining cropland and will encourage a staged, gradual conversion of farmland to sustainable, non-GMO crops in a way that helps family farmers, helps suppliers, helps food supplement manufacturers, helps health-food retailers and helps consumers---all without devastating supply or retail prices, collapsing markets and disappointing consumers.

The FDA’s Double-Barreled Shotgun Aimed at Dietary Supplements

By James J. Gormley

The Food and Drug Administration (FDA) plans to publish a proposed rule to revise the Nutrition Facts panel and related rules by the end of 2012.

According to Elaine Watson in Nutraingredients-usa.com, the FDA said it is “expected to look at serving sizes, daily values, adjustments to label formats and additional nutrient declarations, all of which have the potential to cause controversy.”

For example, if the FDA proposes that daily values be based on Estimated Average Requirements (EARs) instead of Recommended Dietary Allowances (RDAs) or Daily Reference Values (DVRs), the published dosage needed to achieve 100 percent of your daily value would drop dramatically, since EARs are significantly lower than are RDAs.

 
In essence, consumers might believe they are getting enough or a high-potency level of certain nutrients and forego purchasing or buying dietary supplements.

Suppliers of the country’s National School Lunch Program would probably be overjoyed since they could provide less nutritious foods to our kids and still “honor” their USDA contracts.

This new food-labeling scheme is reminiscent of the nutrient potency-labeling shenanigans that  preceded the Proxmire Vitamin Bill battle, albeit, in this case, attempting to dumb down foods while making them appear to  be more nutritious.

As Steve Mister and John Hathcock PhD (from the Council for Responsible Nutrition) wrote:

"In the early 1970s, FDA proposed to restrict the potency of vitamins and minerals in supplements to 150 percent of the Recommended Dietary Allowance (RDA); levels above that would automatically redefine a supplement as a drug and require the agency’s premarket approval. FDA ignored the fact that even some unfortified conventional foods can contain many multiples of the RDA for certain nutrients (e.g., vitamin B12 in liver) and thus be far more ‘potent’ than the vitamin supplements it sought to regulate. Consumers and the industry resisted, and Congress passed Section 411 (Rogers-Proxmire Amendment) to the Food, Drug and Cosmetic Act (FDCA), which specifies that FDA may not classify a supplement as a drug solely on the basis of potency."

The NDI Draft Guidance is engineered to gut, through misinterpretation, many of the most important features of the Dietary Supplement Health and Education Act of 1994 (1994), a law that was partly stimulated by FDA attempts to regulate dietary supplements as food additives, as Mister and Hathcock recently wrote in Nutritional Outlook magazine:

"Thwarted in that effort to call supplements unapproved new drugs [prior to Proxmire], FDA next attempted to classify dietary supplements as unapproved new food additives, thereby imposing on particular dietary ingredients the same requirements for premarket approval as applied to chemicals that were added to food for non-nutritive reasons.  [ ...] Congress then passed DSHEA, which states that dietary supplements shall not be regulated as food additives."

If the NDI Draft Guidance were to be finalized as written, and enforced along the same lines, many of the innovative dietary supplement products consumers use and rely on today would go the way of the dodo bird.
 
The Gormley Files Takeaway: Via two very different tacks, the FDA is attempting to overtly (in the case of the NDI Draft Guidance) and covertly (in the case of the food labeling scheme) roll back or undermine, respectively, the two biggest health-food-industry and consumer victories ever won against the FDA.

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!

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.

Thanks!

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 (http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY=8252) and to FDA Dockets here (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833), 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.

The FDA’s Plan to Cripple the Health Food Industry: Their New War Has Begun

By James J. Gormley

According to a July 7, 2011 report from the U.S. Food and Drug Administration (FDA), Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.

U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.

I am sure that the FDA is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone --- calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) --- could reduce healthcare costs by over $24 billion.

These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements --- such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on ---- it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.

Therefore, it is mystifying to me, and to many others, why the FDA would choose, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.

It is baffling as to why the FDA would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” “what is a new dietary ingredient,” for example, as bases for what is obvious is its new supplement review and enforcement position.

Based on the FDA’s own statements and examples in the guidance, along with a simple exercise of extrapolating from what FDA is saying to what it is they apparently intend, a vast majority of the supplements sold in the U.S. would be drastically affected by review, implementation and enforcement activities along the lines outlined in this document.

Because the guidance is for industry, not for the agency. The agency is already heading down a path that would eviscerate the dietary supplement industry and would cause lasting, irreparable harm to American consumers and healthcare in the United States.

The harm would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from the FDA. The harm would come from whole swaths of products being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already proven to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.

Neither American consumers nor the dietary supplement industry are going to take this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice sitting down.

In fact, a number of consumer grassroots advocacy groups and initiatives are rallying to the cause, including:

• Citizens for Health (http://www.citizens.org/);
• Alliance for Natural Health (http://www.anh-usa.org/);
• Your Voice for Health (http://www.yvfh.org/about/);
• Operation Pushback (http://operationpushback.com/); and others.

I invite all of you to join with and support the critical work being done and about to be rolled out over the coming weeks.

While the fight to pass the Proxmire Bill defined the struggle for health freedom in the 1970s, and the battle for DSHEA was our signature victory in the 1990s, our war now is to protect dietary supplements from the FDA’s concerted efforts, behind the NDI guidance, to rip apart the health-food industry and to make America profoundly less healthy and more sick.

While our first campaign will take a couple of months, FDA has made it clear that it is operating under vastly misguided and adversarial interpretations of the laws governing dietary supplements than given to them by Congress and the American people.

Our defining health-freedom battle of the first century of this new millennium has begun.

Emord on NDI Guidance

From Nutraingredients-USA

By Elaine Watson

If sufficient pressure is exerted by key members of Congress, it is not beyond the realm of possibility that the FDA might suspend its draft guidance on NDIs (new dietary ingredients) or even withdraw it altogether, according to food law attorney Jonathan Emord.
Read More

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

By James J. Gormley

On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186 calendar days after that, on July 1st, the FDA issued a draft guidance on new dietary ingredients.

What is all this about old and new dietary ingredients? Old dietary ingredients (ODIs) are nutritional ingredients ─ herbal extracts and nutrients ─ that were sold prior to 1994 and were considered to be “grandfathered in,” and “generally recognized as safe” when NDI submissions were first required, so manufacturers did not need to worry about ingredients that were always in the food supply in foods or food-based supplements.

NDIs, on the other hand, were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. Notwithstanding, this itself was always considered a strange requirement, however, since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption, so how could these benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.

So, many companies were advised by legal and industry experts to not submit NDI notifications since the products in question were exempt from the requirements since the individual parts of the compound were considered safe anyway. On top of that, the FDA was rejecting so many NDI submissions on administrative grounds alone that companies understandably began to see the NDI process and non-objection threshold as impenetrable, indeed.

Fast forward to this guidance, which was actually originally mandated in our main dietary supplement law, the Dietary Supplement Health and Education Act of 1994 (or DSHEA), but it has somehow taken the FDA 17 years to get around to it.

The FDA and its apologists are saying that this is no big surprise and has been a long time in the making. Be that as it may, natural products industry organizations have raised a number of important objections to the dangers to innovation posed by this guidance and policy and procedures that may well follow from it.

“We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market,” noted the Natural Products Association in a July 6th statement.

As the “decision tree” provided by the FDA with this guidance makes clear, if a new manufacturing process, extraction method or plant part is used, then it is a new dietary ingredient!

This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (such as grain alcohol or glycerin), that these solvents now render the ingredients as NDIs even though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!

As Steve Mister of the Council for Responsible Nutrition (CRN) said to Nutraingredients-usa.com, “They are trying to freeze industry in 1994 and lock us into extraction processed used 20 years ago.”


The guidance also states that synthetic versions of natural ingredients are also NDIs. What!? Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit or soil. We are not talking artificial ingredients here; think vitamin C, as that’s what we’re talking about. If this is followed by FDA, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!

Attorney Marc Ullman, of Ullman, Shapiro & Ullman, told Nutraingredients-usa.com that this position on so-called synthetic nutrients is “preposterous, absolute nonsense” and with “no basis in science.”

In addition, the safety testing requirements recommended for NDIs go way beyond anything that could be reasonably required for herbal ingredients and nutrients. These over-the-top standards would be similar to what is required of food additives. It would not provide more safety; it would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.

According to Ullman in Natural Products Insider, the guidance shows that FDA is taking an “incredibly narrow view of what can be considered a dietary ingredient and an incredibly overbroad view of what would require the submission of an NDI notification.”

What do consumers and retailers need to be aware of regarding this guidance? It is not law, not regulation and not binding . . . however, and this is a biggie . . . it gives a very clear picture of the intent of the FDA to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.

If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.

Gormley Take-Away: What do we all need to do? We need to file a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.