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What Effects Will the Pending FDA Regulation Changes Have on Stevia and Other Substances?

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The FDA is currently receiving comment about Section 912 of its Amendments Act (FDAAA), which deals with the regulation of foods containing substances that have undergone clinical trials; they have now extended that comment period until November 25. The Section 912 regulations could create a major shift in the divide between foods and drugs.

Supplement trade associations, including the Council for Responsible Nutrition and the Natural Products Association, stress the importance of filing comprehensive comments with the FDA. Further clarification is needed because the provision could prevent products from being marketed as dietary supplements if they (a) contain substances that have been subject to clinical trials, and (b) if those clinical studies have been made public. This provision has created a conflict between two federal statutes.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), Section 912 establishes a new provision. The interstate shipment of foods to which certain substances have been added is prohibited by §301(ll). The issue in doubt is whether §301(ll) should be extended to include dietary supplements. If §301(ll) is interpreted to apply to dietary supplements, it will be in direct conflict with the preexisting standard for dietary supplements set under §201(ff). Industry trade groups are seeking for clarification that §201(ff) remains in effect and sets the supplement standards and that §301(ll) does not apply to dietary supplements.
Under section 201, a substance cannot be marketed as a dietary supplement if it has undergone clinical studies which were made public and which were conducted in accordance with an Investigational New Drug application (IND). §301(ll) prohibits the addition of substances to food that have been the subject of clinical trials, without taking into account an IND application providing those studies were made public and a regulation was publicized.
The FDA has received a petition from Coburn and Coffman, PLLC, contending that stevia glycosides are drugs and cannot legally be added to conventional foods. The phytochemicals in stevia—glycosides—have been studied in clinical trials for their potential effect on blood pressure and blood sugar. Cargill and Coca Cola have been reported to be working on the addition of stevia as a sweetener to its beverages.
In a related matter, the FDA has scolded Bayer Corporation in two warning letters for never submitting proof that two of its products (Bayer Women’s Low Dose Aspirin + Calcium, and Bayer Aspirin with Health Advantage) are effective in battling heart disease and osteoporosis. The FDA associate commissioner has indicated that the FDA will take enforcement action because treatment for those diseases must be reviewed by government scientists and cannot be sold over the counter. Bayer has responded that they stand behind the claims on these products, which are not intended to replace professional medical advice. It is very reminiscent of trying to communicate with consumers the science addressing certain health conditions and the use of dietary supplements in the days that led up to the passage of the Dietary Supplement Health and Education Act.
The FDA has been criticized because many believe their vested interests often color regulatory actions, and because advisory committees have members with conflicting interests that potentially put consumer safety at risk. Numerous organizations believe that the FDA obstructs medical science and innovation; forbids and censors the communication of legitimate, peer reviewed scientific research; and protects entrenched medical monopolies that pay the FDA’s bills and hires its employees.

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