Thursday, March 15, 2012

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, 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The NDI Draft Guidance is engineered to gut, through misinterpretation, many of the most important features of the Dietary Supplement Health and Education Act of 1994 (1994), a law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.
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