The Alliance For Natural Health

Government Releases Report to Justify FDA Pre-Approval of Supplement Claims

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supplement labelThey say “stakeholders” have raised concerns about these claims. Could those “stakeholders” possibly be members of the pharmaceutical industry?

The Office of Inspector General (OIG) of the Dept. of Health and Human Services, parent agency of the FDA, has released a report called “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements.” The word in Washington is that it is a naked attempt to support new legislation that would require FDA pre-approval of all structure/function claims—which food and supplement producers are legally allowed to make.

Structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.” Under FDA rules, one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. The science doesn’t matter to the FDA. Nor does freedom of speech.

The OIG said it reviewed structure/function claims on dietary supplement labels and concluded that:

  • FDA should seek new statutory authority to review structure/function claims to make sure they are truthful and not misleading. This means they think legislation should be introduced to provide FDA with authority to pre-approve structure/function claims before nutritional supplements are marketed.
  • FDA should improve market surveillance for illegal structure/function claims, expanding it to include retail establishments, trade shows, and promotional events, to make sure vitamin stores are not making disease claims and are displaying proper disclaimers on their structure/function claims.

Clearly, FDA pre-approval of structure/function claims would be disastrous given the agency’s longstanding bias against nutritional supplements. Many, perhaps most, claims would never be approved and the process could be very lengthy.

Pre-approval would also create an even greater advantage for pharmaceutical drugs. If supplement makers are prevented from making even these most basic of claims about their products, the public won’t know about their ability to help heal and balance us, and will have only drugs for their health needs.

Who requested the study? OIG says the Government Accountability Office and “public interest groups”—that is, the Center for Science in the Public Interest (CSPI), and Public Citizen—raised concerns, and that “stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support.” CSPI has had an agenda against structure/function claims for a while, even requesting the FDA to abolish structure/function claims altogether, as we reported two years ago. And no one wants FDA to suppress information about the effectiveness of supplements more than the pharmaceutical industry.

The study itself is remarkable for the number of flaws in its methodology and analysis:

  • They sampled only 119 supplements out of 90,000 supplements on the market. Why? Because they chose to sample weight loss supplements and supplements for immune support. The researchers knew that weight loss supplements are usually the worst offenders, are certainly not representative of the nutritional supplement industry as a whole, and this intentionally skews the results.
  • Companies had to voluntarily submit whatever substantiation they had for their claims (66 of 104 companies did so), which again is hardly representative of the substantiation available for all supplement structure/function claims.
  • Not surprisingly, FDA could not readily determine whether manufacturers had submitted the required notification for their claims. FDA could only locate 21 of the 127 notification letters. This points to serious disorganization within the FDA, which calls into question whether FDA even has the capacity for greater enforcement.
  • The report says that 7% of the supplements reviewed lacked the required disclaimer, and 20% included prohibited disease claims on their labels. These instances, the report says, raise questions about “the extent to which these structure/function claims are truthful and not misleading.” We would point out that it was 7% of the 127 they selected, which means that only nine supplements lacked the required disclaimer. And not having a disclaimer doesn’t mean the information provided in the structure/function claims are not truthful or are in any way misleading! Moreover, disease claims for supplements are illegal, and FDA already has authority to enforce against them. If companies are making disease claims, they are certainly violating the law—although they are not necessarily being either misleading or untruthful.

This report is nothing more than a blatant bid for new anti-supplement legislation to be enacted. As always, ask yourself: who would benefit financially from suppressing supplement competition for drugs?

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