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CFH Submits Its NDI Comments to the FDA

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October 6, 2011

Division of Dockets Management
(HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Re: Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

Dear Commissioner Hamburg:

Citizens for Health (CFH) is hereby submitting its organizational comments on the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

CFH and its over 100,000 supporters call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the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 this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit and letter of DSHEA.

BACKGROUND

According to a July 7, 2011 report from your Agency, 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.

With this as a backdrop, we are certain that your Agency 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.

THIS GUIDANCE DOCUMENT

Therefore, it is mystifying to us, and to many others, why your Agency would endeavor, 17 years after the passage of DSHEA, to re-interpret the laws governing dietary supplements as evident in this Draft Guidance.

It is likewise baffling as to why your Agency 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,” and “what is a new dietary ingredient,” for example, as bases for what is obvious is your new and intended supplement and ingredient review and enforcement position.

Your Agency is attempting to drastically change the law by saying that finished product manufacturers must submit an NDI for every product that contains an NDI or whenever a formula is changed, if an NDI is present.

Your Agency is in disregard of the law, Section 413 [21 USC §350b] of DSHEA, which says an NDI submission is not required if “there is a history of use or other evidence of safety” supporting its inclusion, use and marketing prior to 1994. Instead, your Agency is proposing that NDI submissions be product-specific rather than ingredient-specific, which contravenes the spirit and the letter of the law.

For your Agency to assert that newer technologies and improved processing and extraction methods would render ingredients as NDIs since these methods were not known prior to 1994 is akin to saying that meat-packing plants should observe the filthy and unhygienic practices that led to today’s modern food-safety system because these antiquated methods were approved then and these new processes are different.

Review and enforcement based on the re-interpretation of DSHEA expressed in the guidance would be expected to cause major disruption in the dietary supplement market, forcing a significant number of products off the market, resulting, according to estimates by a leading economist cited by another commenter, in revenue losses of over $1 billion dollars and causing the unemployment of over 100,000 Americans.

In the area of innovation, the direct result of policies behind this guidance would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from your Agency.

The American people would be harmed by the market and access implications within this document.

The harm would come from whole swaths of products and categories (such as probiotics) being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, or even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already known 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. The harm would come from reduced consumer health in America as innovative, high-quality dietary supplements are removed from shelves or never see the light of day.

Your Agency’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law on the basis of this alone.

CONCLUSION

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

We call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA 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 this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

Sincerely,

James S. Turner, Esq.
Chair
Citizens for Health
jim@swankin-turner.com

James J. Gormley
Vice President and Sr. Policy Advisor
Citizens for Health
jamesgormley01@gmail.com

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.

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.

NOW Foods Responds to “Dangerous Supplements” Article

Courtesy of NOW Foods

The September 2010 Consumer Reports article entitled “Dangerous Supplements” highlights 12 dietary supplements the authors claim are potentially dangerous. This article has led to numerous news stories that have aired on national TV programs. However, supplement maker NOW Foods believes these stories contain inaccurate and misleading information. This may well discourage consumers from availing themselves of the benefits that nutritional supplements convey, and needlessly raise the specter of danger.

Consumer Reports and the related media stories refer to the supplement industry as operating with little FDA [U.S. Food and Drug Administration] oversight. The reality is that the supplement industry is regulated by the FDA, with manufacturers being audited by the FDA to ensure they meet cGMP requirements (Good Manufacturing Practices). The FDA also regulates labels: all claims must be truthful and not misleading, all ingredients must be listed on the labels, and companies must have documentation to prove claims that must be maintained. Any new supplement ingredient introduced must go through a vetting process with the FDA before it can be legally marketed, similar to the FDA drug approval process in terms of demonstrating safety.

Numerous FDA commissioners have stated that they do have ample authority to regulate the supplements industry – they just don’t have the resources. This is why the industry has long, and very loudly, supported legislation to give FDA more resources to crack down on the fringe companies that do not follow the laws regulating the industry. Also, the FDA has the legal authority to remove from the marketplace any dietary ingredient that they determine to be dangerous.

Supplements have a proven track record of safety, in fact a much better track record than pharmaceuticals, over-the-counter (OTC) medicines and even common foods. For example, the most recent annual report of the American Association of Poison Control Centers published in the Journal of Clinical Toxicology reported zero accidental deaths from dietary supplements. Consumers should be more concerned about acetaminophen adverse events, which cause a large number of deaths (estimates vary widely, but usually range between 3,500 and 10,000), liver failures and ER visits annually.

Additionally, most of the herbs listed in the article are not widely available, and certainly not sold by the vast majority of the industry. To broadly characterize dietary supplements as dangerous on the basis of a handful of products that they claim may be potentially unsafe, is sensationalism that discredits the proven safety record of this product category and fails to recognize that millions of Americans choose to take supplements every day because they derive significant benefits from them.

In a related article, Michael McGuffin, the head of the American Herbal Products Association (AHPA) had this to say.

Selling the “Vitamins Don’t Work” Myth: What’s the Real Story?

By John Pittman, MD via www.acam.typepad.com

Vitamin

In recent years, newspapers have been trumpeting the news that vitamins C, D and E—as well as multi-vitamins preparations—do not prevent heart attack, stroke or cancer. These reports have led to a great deal of confusion and disillusionment among health-conscious consumers, many of whom already take supplements and are genuinely interested in practical ways to bolster their health and well-being. But is it really true that vitamin supplements are a waste of money and possibly even harmful for you? What are we to make of recent media pronouncements that most people are popping these pills without deriving any benefit whatsoever?

First of all, it’s important to understand that the vast majority of these negative reports are, in reality, old news wrapped in tabloid-style headlines. Many news reports fall woefully short of telling the whole story about a scientific study or about the conclusions of the scientific community regarding a specific issue. Media reports often present a study’s findings in a scattershot, fragmented manner, and without the proper scientific context—for example, by failing to acknowledge the many studies that have, in fact, found vitamins to be beneficial to the people who take them.

Jane Brody’s Personal Health column in the 24 March 2009 edition of the New York Times is a case in point. The report was titled “Extra Vitamin E: No Benefit, Maybe Harm.” Because Brody is widely respected as a health journalist, her messages are often taken as gospel. But those who understand the fundamentals of nutrition and the science of supplements can read between the lines. For example, before discussing the vitamin E research, Brody makes this comment: “Some vitamin E enthusiasts object that the clinical studies used what they consider the wrong form of the vitamin, saying that each of the vitamin’s eight forms has its own biological activity. But the kind of vitamin E used in most studies, alpha-tocopherol, is the most active form in humans, according to the National Institutes of Health’s (NIH’s) Office of Dietary Supplements.”