Thursday, April 24, 2008

Under-the-Radar Petition at the FDA from American Dietetic Association and Others

Now that the pharmaceutical industry has its first FDA approved weight-loss drug available to the public, over-the-counter (OTC) no prescription needed Orlistat, it's time to eliminate the competition in the marketplace - dietary supplements - used by many Americans to help with weight loss.

On the Regulations.gov website, an interesting petition exists that has had virtually no attention in the media - Treat Weight Loss Claims for Dietary Supplements as Disease Claims - filed as a citizen petition to the FDA by the American Dietetic Association, the Obesity Society, Shaping America's Health and GlaxoSmithKline Consumer Healthcare.

The full document PDF is available here as well as on the page linked above.

The document is quite interesting and it's obvious the petitioners do not want input from the public or an open comment period - they just want the FDA to take the action they request, no questions asked, no comments, no looking at anything other than what they've provided the FDA. Basically telling the FDA to just trust them!

The petition requests FDA to require manufacturers of weight loss supplements to obtain FDA review of their claims before the products can be sold, asserting such claims are "disease claims" as clearly indicated by the title page of the petition document - "Citizen Petition of the American Dietetic Association, The Obesity Society, Shaping America's Health, and GlaxoSmithKline Consumer Healthcare requesting the Food and Drug Administration to determine that claims that dietary supplements promote, assist, or otherwise help in weight loss are disease claims under Section 403(R)(6) of the Federal Food, Drug and Cosmetic Act."

We learn more in the section Action Requested, "In support of this action, petitions present extensive scientific evidence and consumer survey data that has been developed during the past decade. This new information conclusively establishes three critical facts. First, the condition of being overweight is a significant risk factor for serveral serious diseases, including diabetes, cardiovascular disease and cancer. Second, many Americans understand the health risks of being overweight and they rely on dietary supplements to lose weight. Third, there is little, if any, evidence, indicating that dietary supplements marketed for weight loss actually work. As a result of these three facts, many Americans are being thwarted in their efforts to lose weight, and reduce the risk of disease, by ineffective weight loss supplements."

To support their postion, they assert that claims such as the above are "qualified health claims" that require authorization and approval from the FDA and state they believe "there is no credible evidence whatsoever to support any type of qualified health claim for a weight loss supplement...In the case of weight loss supplements, there is no credible evidence to indicate that supplement themselves assist in weight loss or, even if they do so, that there is a commensurate risk reduction of disease from the use of any such supplements."

A qualified health claim is a claim authorized by the US Food and Drug Administration (FDA) that must be supported by credible scientific evidence regarding a relationship between a substance (specific food or food component) and a disease or health-related condition. Both of these elements -- a substance and a disease -- must be present in a health claim. An example of a qualified health claim is: "Calcium may reduce the risk of osteoporosis."

The petitioners even go so far as to strongly suggest public input and comment is not necessary, they carefully take the position that overweight need not be redefined as a disease, but rather a risk factor for disease; thus providing the FDA an opportunity to act in their favor without notice or comment rulemaking.

"Finally, in this context, petitioners must emphasize that FDA is not required to engage in norice and comment rulemaking under the Administrative Procedures Act (APA), 5 USC 553, before implementing the actions requested in the petition. That is because the petitioners are not asking FDA to change its earlier interpretation of the way that two of the criteria in the structure/function rule apply to weight loss claims. Rather petitioners are requesting FDA to apply a particular provision in its existing regulations to weight loss claims in light of the substantial body of literature and consumer survey data developed during the past decade. An agency's application of its regulations to particular factual scenarios certainly does not require notice and comment rulemaking under the APA. Moreover, to the extent that FDA concludes that granting this petion woudl require the agency to modify its earlier statements about weight loss claims in the preamble to the structure/function rule, such statements constitute "advisory opinions" that can be modified at any time following notice in the Federal Register."

At least we find public comments are open online (even if nothing is found elsewhere online to hint this petition even exists)....the public comment and submission page is here.

Time to get to work!

7 comments:

  1. Anonymous7:12 PM

    Does this mean that Medicare and Medicaid will be reequired to support claims on this disease state?

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  2. What do they care if they increase the paperwork burdens of the nations health system? Helping to prevent disease is not their real goal, their real goal is only to increase their own profits, job security and phony scientific legitimacy. It's a racket.

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  3. Has the ASBP been notified of this? Their responses will undoubtedly carry more weight.

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  4. Has the ASBP been notified of this? Their responses will undoubtedly carry more weight.

    I believe so.

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  5. Anonymous1:16 PM

    Hello Regina!

    Just wanted you to know I truly appreciate your work!

    A few years back, we both posted on an AOL debate board. That was when I impressed regulars by calculating their TG, using only their TC, HDL and LDL -- ring a bell?

    Your March 20 column on Dr. Wortman was of great interest to me! I should note my own lipids improvements were even more impressive than his study group!

    Perhaps, one day, you can help me better understand why my glucose levels tend to be higher (88 or so vs 78 - 80 mg/dl) in the A.M. than after much shorter fasting periods later in the day (even with serious carb restrictions in late meal).

    Not a diabetic, but frequent testing keeps me on my toes! Also helps me better understand my glycogen "tank" capacity, lipid relationships, etc!

    Best regards,

    Jack

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  6. The precedent here is worrisome though. Let us say that the FDA officially declares obesity a 'disease state' but 'not a disease' and that anything related to obesity in any way, even indirectly, is hence essentially a 'medicine'. What implications might this have for all supplements, even for ordinary foods? Will the FDA end up being petitioned to put warning labels and support extra taxes on meat and cheese because fat is considered unhealthy by today's mainstream standards, for example?

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  7. Hello,

    I appreciate you blogging about this issue and informing others. I work for the Dietary Supplement Information Bureau, which is a not-for-profit organization that promotes health information. We have an article on this topic over at our site, http://dsib.org/GSK.

    Thank you for your time,
    Derek

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