CRN urges FDA interpret adverse events bill with caution

By Clarisse Douaud

- Last updated on GMT

Related tags: Dietary supplement, Food and drug administration, Fda

The Council for Responsible Nutrition (CRN) has expressed its
concern to the US Food & Drug Administration (FDA) over alleged
labeling requirements the agency may include in its upcoming
adverse events reporting guidance.

In a letter signed by CRN president and CEO Steve Mister, the trade association said it has picked up on certain elements of the upcoming guidance via the press and from FDA comments at industry meetings. The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how to use this. While FDA's guidance would not be binding, CRN is concerned litigation would follow it as such - thereby adding an extra burden on industry to conform to the labeling. "To issue guidance that would require de facto label changes would cause a great deal of confusion as responsible industry and FDA work together to ensure this system provides meaningful signals,"​ wrote Mister in the July 31 letter addressed to the director of FDA's Center for Food Safety and Applied Nutrition, Robert Brackett. Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers. CRN is now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report".​ The document will essentially outline how the bill is to be interpreted. The association objects to the potential stipulation for a manufacturer's full address on labels, which it says is not required for any other FDA-regulated products. "This commonsense rule - that the street address is not required when otherwise readily accessible - has been in place for nearly seventy years,"​ states the letter. The Food, Drug & Cosmetic Act already requires food labels (including those for dietary supplements) contain the name and place of business of the manufacturer, packer or distributor. However, the street address can be omitted if it is listed in a telephone directory. CRN said it conducted an analysis of other references to address and place of business in the Act, but found no other case where the agency has interpreted the words to require a street or post office box on the labeling of products under its jurisdiction. The so-called introductory language would instruct consumers how to use the contact information. For instance, CRN uses the examples: "To report an adverse event, contact..."​ and "If you experience problems with this product, contact…"​. According to CRN, if FDA calls for a full street address and new introductory language in its guidance document an extra burden will be placed on industry - especially if compliance remains effective for December 22, 2007. Mister recommends that in the case of label changes, a three-year time frame would be necessary for manufacturers to fall in line with the requirements and use up their existing label stocks. The trade association also highlights that, in its passing of the bill, Congress did not suggest any label changes, except to the extent that the address on a dietary supplement label must be a domestic one. "Accordingly, there are no grounds for FDA to issue a de novo interpretation of the "address" requirement in the AER requirement,"​ states the letter. CRN also calls into question the alleged suggestion from the federal authority that the purpose of the AER legislation is to increase consumer reporting and create greater consumer awareness as to these reports. "We find no such stated intent in the law or committee report and would caution the agency not to invent its own desired intent for the law,"​ wrote Mister.

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