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

September 13, 2011

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

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and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.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:

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.

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

By James J. Gormley

In our August 23rd post, we alerted you to a U.S. Food and Drug Administration (FDA) draft guidance on “new” dietary ingredients. We recommended that our 100,000+ members ask the FDA to withdraw the guidance and to not adopt the policies underpinning the interpretation behind this “guidance” in its review and enforcement activities.

In the meantime, Attorney P. Scott Polisky and Susan Brienza — on behalf of Jarrow Formulas, many members of the natural products industry and consumers who value innovation in their dietary supplements — are asking the FDA to at least extend the comment period for this guidance until July 5th, 2012.

Short of an immediate withdrawal of the guidance, Citizens for Health agrees with Attorney P. Scott Polisky and also with Hyman, Phelps and McNamara, which, in its July 26, 2011 request letter, said that “a one-year comment period is further justified given that there is no apparent and certainly no urgent public health need for a shorter period.”

Indeed, the draft guidance itself ignores the stellar record of supplement safety (vis-à-vis drugs and other FDA-regulated products).

As shown in FDA’s response to a 2006 Freedom of Information Act Request (FOIA) by JFI, in stark contrast to the more than 400,000 annual Adverse Event Reports (AERs) for drugs, there were only 129 non-Ephedra serious AERs for supplements in over 12 years — and six deaths that the FDA, in its 2006 response, found to be “biologically plausible” but not caused by the supplements.

Clearly, as many have noted, dietary supplements are safer than tap water, table salt, aspirin and even food, and it is unlikely that the newly proposed guidelines will make them any safer. Finally, when needed, the FDA has numerous regulatory and enforcement mechanisms (supplement GMPs, import alerts, Physicians Advisories, inspections, mandatory MedWatch reports for serious AERs, etc.) with which to monitor and ensure supplement safety.

Let’s ask the FDA to withdraw the guidance and to assure American consumers that it will not be heading down the road of trying to re-classify hundreds, if not thousands, of safe, historically used ingredients as “new dietary ingredients,” as this could serve as a fatal blow to the dietary supplement industry, especially those companies which feature innovative processes and formulations!

In the meantime, we can buy time by asking them to extend the comment period to July 2012.

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

By James Gormley, Senior Policy Advisor, Citizens for Health

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 NDIseven 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.

Dietary Supplement Labeling Bill is No Solution

July 19, 2011

Washington, D.C. – At the end of June, just before the sleepy holiday weekend news cycle, Senator Dick Durbin (D-IL) introduced S. 1310, the Dietary Supplement Labeling Act of 2011. The bill is a response to recent marketing tactics by unscrupulous food companies intended to circumvent Food and Drug Administration (FDA) standards.

The most familiar example, and, apparently the specific reason for the legislation, is the brownies product called Lazy Cakes. Concerned parents made the story national news due to concerns that their children were consuming the brownies while they were unaware that they contained melatonin. The makers of Lazy Cakes, afraid that their profit margin would take a serious blow if they had to add a warning to the product label, decided to re-brand the brownies as “dietary supplements”.

Citizens for Health understands and shares the concern that makers of treats like Lazy Cakes or the plethora of “energy drinks” that have exploded on the market in the last decade are exploiting our system of consumer safety regulations and unethically targeting children with their duplicitous marketing. However, the answer is not directing more scrutiny and placing a greater financial burden on dietary supplement companies whose products have a long-standing, demonstrated track record of safety.

Supplements are not drugs, and therefore, deserve their own system of regulation – and that’s the point. Such a system already exists thanks to the Dietary Supplement Health and Education Act of 1994 (DSHEA), and it has done a more than adequate job protecting consumers largely due to supplement companies’ compliance with, and support of, that system.

S. 1310 grants the FDA and the Institute of Medicine the power to compile a list of dietary ingredients that pose a potential threat. And there’s the rub. What are the measures by which an ingredient will be deemed to pose such a threat? And why give the FDA, an agency that has shown an anti-supplement bias in the past, the power to arbitrarily amass a list of “potentially dangerous” dietary ingredients, especially when there is already a system in place to ensure the safety of supplements?

Besides, the FDA is already overburdened and understaffed, and has enough trouble keeping up with its existing responsibilities for policing pharmaceutical companies in their rush to receive permission to sell their hastily tested, potentially dangerous drugs. Now food companies are resorting to underhanded tactics and masquerading some of their products as supplements as a way of avoiding the FDA regulations intended for them, placing even more pressure on the FDA to do their job. The solution isn’t to investigate supplements and dietary ingredients – it should be to investigate the food companies exploiting the system!

Put simply: At best, S. 1310 is a bad bill, albeit with good intentions. At worst, it uses parents’ fear about what their children are consuming as an excuse to take another crack at imposing unnecessary and redundant regulations on the dietary supplement industry, which has demonstrated time and again its ability to ensure the safety of its products.

More than 150 million Americans use some form of dietary supplement on a daily basis, and this should come as no surprise. Supplements are among the safest products available and are rooted in a wellness-based approach to health. The misguided scrutiny proposed in S. 1301 is better reserved for food companies trying to “play the system” – like the makers of Lazy Cakes – and for pharmaceutical companies whose products are employed as part of a sickness-based approach to health. After all the data demonstrating the potential negative impacts of pharmaceuticals increases daily. Senator Durbin has shown in the past his willingness to preserve our ability to safely access products, like dietary supplements, that contribute to maintaining our health and wellness. We must take this opportunity to respectfully alert him to his error in sponsoring S. 1301 and help him resume his role as a champion of the natural health consumer.

You can stop this bill before it ever has a chance – click here to send a message to your Senators NOW!

The FDA: A Warning Letter From American Taxpayers

By James J. Gormley

From American Chronicle

In June 2007, the U.S. Food and Drug Administration (FDA) issued the final rule on Current Good Manufacturing Practices (cGMPs), which, according to Nutraingredients-usa.com, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.”

Vasilos Frankos, Ph.D, outgoing director of the FDA’s Division of Dietary Supplement Programs, told health-food industry magazine, Nutritional Outlook, that the FDA is looking to greatly increase the number of inspections it performs.

If companies are inspected by FDA and receive a Form 483 letter (List of Inspectional Observations) noting noncompliance, Frankos said that they should respond to FDA quickly, preferably within 15 days. Form 483 letters are used by the FDA to document and communicate concerns discovered during these inspections. According to the FDA, these letters:

“…list observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance”

As of April 29th, reported Nutritional Outlook, FDA had performed 66 dietary supplement GMP inspections. “Ultimately, the agency may aim to perform as many as 191 inspections or more by the end of this year [2011],” the trade publication noted. “By contrast, FDA performed 84 total inspections in 2010.”

With reports noting that 25 percent of supplement companies did not pass their FDA GMP inspections, the “FDA is due to assist industry overcome these and other issues by producing a compliance program for dietary supplements that is in the clearance phase and is due to be published imminently,” FDA senior advisor, Carl Reynolds, told attendees at a recent industry conference.

But will it assist companies? And, more importantly, what’s really at stake here?

It’s hard to comply with every requirement when the FDA holds all of the cards and provides guidance that is either surfacey in many cases or nearly impossible to carry out in others. With the agency’s surfeit of discretionary authority, the FDA can decide what is adequate documentation and what constitutes satisfactory compliance—and what is or does not—with many well-meaning companies left bewitched and bewildered by the unexpected 483 letter or warning letter they receive.

According to Jonathan Emord, one of the lead architects of the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA admits that cGMPs:

  • may result in the elimination of over 100 dietary supplement companies;
  • will likely increase the cost of dietary supplements; and
  • will likely decrease demand for dietary supplements.

“These regulations impose costly obligations on the industry and focus primarily on process rather than outcomes,” noted Emord.

Knowing this, Emord and his colleagues commissioned Dr. Steve Hanke, former senior economist on President Reagan’s Council of Economic Advisers, to evaluate the economic impact of the cGMP regulations and he predicts the burden will be approximately 10 times higher than the FDA has predicted.

What if the FDA says a company’s paperwork is not in compliance? Failure to comply with the regulations is considered “adulteration,” and the agency does not need any proof that products produced by the company “present an actual risk of illness or injury to the public.”

Emord and the consumer health group, ANH-USA, and others challenged this in federal court and sued the FDA over GMPs. “Our concern has been that FDA is given authority to treat all GMP violations the same—which means that a paperwork violation carries the same penalties as selling food that harms the public: for both infractions, one is deemed to be selling ‘adulterated’ products, with the same jail sentence,” noted ANH-USA.

“We said those regulations went beyond the statutory authority of the FDA to regulate dietary supplements—that they were unconstitutionally vague (in violation of the Fifth Amendment’s due process clause), arbitrary and capricious, and an abuse of the Administrative Procedure Act.” The judge in this case ultimately sided with the FDA.

Gormley Take-Away: The way the FDA is going about implementing the cGMPs is misguided, at best, and malign, at worst. No consumer, health food store or legitimate manufacturer has a problem with the concept and practice of Good Manufacturing Practices. However, we all should have a problem with supplement companies being set up for failure by a combination of flimsy guidance and cut-throat enforcement tactics. Companies deserve to have clear guidance and to not be buried in administrative recordkeeping and paperwork requirements. These same companies also deserve to be treated fairly and respectfully, for example to be given a heads up about something that needs correction instead of immediately being slapped with an FDA Warning Letter. While the FDA will be gunning for supplement companies in the second half of 2011, all of us need to be closely watching how our tax dollars-funded agency is conducting itself as well. Because it is high time that the agency receive a warning notice of its own from the American people that we will not tolerate continued tax dollars being spent on malicious witch hunts against companies that produce wholesome food products that help us live better and healthier.

Quality: Giving It A Chance

If a U.S. finished product manufacturer vigilantly quarantines ingredient shipments and vigorously tests everything that comes in (from qualified suppliers), if retailers stop stocking those “sexy” but probably spiked products, and if consumers are educated as to how dangerous (and dumb) it is to seek out “too good to be true” products……then we have a chance.

The Food Safety Law: The Way Forward!

Passage of this bill won’t change much unless the bill is funded. In this economic environment, it will be difficult to get the $1.4 billion required to implement this bill without some revenue generator, which this bill does not include. There has already been talk from Republicans in the House that they will not fund the bill. The government is currently under a continuing resolution (CR) which expires on March 4. So one of the first challenges for the new Congress is how they handle the Fiscal Year 2011 budget. Therefore, it is unlikely that anyone will get an increase in this environment. Some lobbying from states is also anticipated since they’ll be able to seek a variance from the produce safety standards as long as they can show that they have procedures in place to reach the same goals.

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We Will Make Our Voices Heard in 2011!

Just as with voting, being an informed, active and participatory citizen is essential to protecting and advancing democracy. As Mr. Buckley sagely noted, we must be obtrusive, we must be committed and we must be assured in claiming our rights. By being knowledgeable and informed about the issues, we do not need to worry about our message or our cause being construed as ambiguous. We must question “Authority” since authority is merely power lent to agencies and officials to carry out the public will and to fulfill the public good.

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