Tuesday, June 05, 2012

Sufficient Regulation of Supplements

Critics claim that dietary supplements are under-regulated, which is arguably inaccurate. Critics suggest that the FDA should have the power to ban synthetic analogues of botanical ingredients even when there is no credible safety issue, a major expansion of government authority. There are disturbing attempts to expand the role of unelected government bureaucrats as censors of nature-identical ingredients, even those with a history of safe use.

The FDA recently reinterpreted a 1994 law requiring pre-market notification of New Dietary Ingredients (NDI) unknown to the marketplace or our food supply. The law grants it authority over novel ingredients, not products, by requiring notification, rather than pre-approval. Now the agency is promoting a radical vision by prematurely enforcing its widely criticized Revised NDI Guidance that violates the letter and spirit of the law. FDA asserts the unilateral power to change from requiring pre-market notification of a new ingredient to a de facto registration giving it virtual veto power over all products containing that ingredient. Under its new interpretation, any change of processing or source (i.e. synthetic botanical) gives the FDA power to reject an ingredient even when indistinguishable from one in the food chain.

FDA lacks not only legal authority, but resources to screen thousands of products explicitly regulated as a food category with a presumption of safety. The FDA rejects most pre-market notifications of new ingredients; slowing introduction of new dietary supplements to the marketplace.

Industry critics ignore how dietary supplement regulation has evolved. Mandatory Good Manufacturing Practices (GMPs) are being vigorously audited/enforced by FDA, requiring identity, potency, and safety testing plus rigorous procedure documentation. All serious adverse events must be reported to the FDA within 15 business days. GMP audits and NDI notifications represent pre-market monitoring; AERs post-market surveillance. The Food Safety Bill enhanced FDA’s recall authority. This regulatory regime is so successful that for years there have been no deaths from dietary supplements reported to Poison Control Centers. Current laws work. We don’t need a virtual government takeover of the dietary supplement industry under the pretense of safety.

No comments: