Sabinsa Submits Comments to FDA on Implementation of Section 912

Sabinsa Corporation yesterday filed comments with the FDA in response to the Agency’s request for information relevant to its implementation of § 912 of the Food and Drug Administration Amendments Act of 2007. This section, titled “Prohibition Against Foods to Which Drugs or Biologics Are Added,” was effective immediately upon the passage of FDAAA on September 27, 2007. The FDA’s request for comments addresses how it is intending to implement this law. Primary areas of concern identified by Sabinsa relate to a provision of the new law that prohibits the adding of substances to food for which substantial clinical investigations have been conducted and made public. A broad application of this part of the new law would potentially force dietary ingredients that have undertaken the New Dietary Ingredient notification process off of the market while erecting a substantial barrier to entry into the mainstream food market for responsible companies like Sabinsa that undertake serious investigations of the health benefits provided by the ingredients they develop

“This has a potentially chilling effect on companies investing in science relating to dietary supplements,” said company CEO Jeff Lind. “Sabinsa believes that if the new law is applied to dietary supplements, manufacturers will be forced to make a “Hobson’s choice’ between conducting research on their products and marketing them as ‘food’.”

“That this would apply to supplements is nonsensical,” stated industry regulatory attorney Marc Ullman, who drafted Sabinsa’s comments. “A product can be a dietary ingredient even if you have had clinical investigation, as long as no one has filed an IND application. If Congress intended otherwise it would have said so at the time it put section 912 in place for “foods”. Any other outcome would be especially ironic in light of the constant criticisms of our industry that we do not conduct enough research.”

Sabinsa’s comments reference that the company conducted 9 clinical studies on its Garcinia cambogia, for which it holds two patents, as an example of products which would be negatively impacted by this implementation.

Sabinsa Corporation, founded in 1988, is a manufacturer and supplier of herbal extracts, cosmeceuticals, minerals and specialty fine chemicals.

Sabinsa's mission is to provide alternative and complementary natural products for human nutrition and well-being. Over the past 20 years, Sabinsa has brought to market more than 100 standardized botanical extracts and privately funded several clinical studies in conjunction with prestigious institutions in support of these products. With more than 80 scientists working full time conducting ongoing research both in India and the United States, Sabinsa continues to develop and patent phytonutrients for the world market. All products intended for human consumption are certified Kosher, with some certified Halal.

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