CRN Submits Comments on Latest AER Guidance

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The Council for Responsible Nutrition (CRN), Washington, D.C., submitted comments to FDA today regarding the agency’s draft guidance related to the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the Act) entitled, “Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” which was published on January 2, 2008.

First and foremost, CRN believes this most recent draft guidance, which was not stipulated in the Act by Congress, is entirely unnecessary. In addition, the association objects to FDA’s attempt to impose these “recommendations” through guidance rather than through notice and comment rulemaking as should be the case for label changes. With regard to substance (as opposed to procedure), CRN also opposes FDA’s “recommendation” to include prefatory language—i.e. “To report a serious adverse event or obtain product information, contact…”—on the label of dietary supplements instructing consumers of the purpose of the domestic address or phone number on the label on the grounds that such introductory language is counter to Congressional intent and unnecessary. To this end, CRN points out that a report from the Senate Health, Education, Labor & Pensions Committee for the legislation already states: “The legislation does not require the label to make any statement other than providing the address or phone number.”

For FDA to “recommend” that such a statement appear on the label flies in the face of Congress’ statement, CRN says. “The intent and spirit of the Act is to require manufacturers to report to FDA the serious adverse events that they receive, and to assure that consumers who want to contact the manufacturer have adequate information to do so,” the association said. “It is not to draw undue attention to the possibility of an adverse event, to predispose consumers to expect they will experience an adverse event while using the product, or to incentivize consumers to report more adverse events to manufacturers. By drawing undue attention to the possibility of an adverse event on the label, FDA is doing just that.” Further, CRN believes product labels serve many other purposes, which is why it is unreasonable to highlight adverse events as the sole, or at least the primary reason to contact the company.

CRN also disagrees with FDA’s interpretation of the meaning of “domestic address,” believing that the statute does not require a street address on the label. CRN states that it is concerned the agency has not properly accounted for the magnitude of costs and time associated with widespread label changes that would need to occur as a result of these interpretations by the agency.

Moreover, CRN believes FDA would be departing from the longstanding position, embodied in its regulations for the labeling of all FDA-regulated products, that a street address is not required where it is shown in a current city directory or telephone directory. “Presumably, the address, or ‘place of business’ requirement that has existed for these other products addresses the same issue as it does in this case—namely to give consumers a way to contact the company responsible for the product,” CRN said. “Why is it not good enough for dietary supplements?” In light of this final point, CRN urged FDA to make the soonest possible decision with respect to the fate of this draft guidance.


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