Concern over AER labelling guidance

A US Food and Drug Administration call for supplements to include prefatory language on labels inviting consumers to report adverse health events, alongside a street address, has provoked a strongly worded response from the industry.

The Washington DC-based Council for Responsible Nutrition said the draft FDA guidance went beyond the new Dietary Supplement and Nonprescription Drug Consumer Protection Act, which obliges supplement manufacturers to report serious adverse events to the FDA and to keep a record of less serious events.

In a submission to the FDA, CRN vice president, scientific & regulatory affairs, Andrew Shao said the organisation supported the requirements of the new law, which came into force in December, but objected to the FDA guidance on the grounds it was "not stipulated in the Act by Congress and is entirely unnecessary."

In the draft guidance the FDA says it recommends labels "bear a prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events." It suggests companies use the text: "To report a serious adverse event or obtain product information, contact..."

The domestic address should be in the form of a "street address or PO Box," the FDA adds.

But Shao said: "Such introductory language is counter to Congressional intent. 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."

FDA's interpretation of "domestic address," as it appeared in the Act, differed from that of "place of business" in the Food Drug & Cosmetic Act, said Shao. This Act requires only a company's city, state and zip code to be included on the label, not a street address.

The FDA had failed to undertake an economic impact analysis of the recommendations, said Shao, which could cost the industry at least $300 million. Some existing label stocks — companies typically keep two years' worth — would also be have to destroyed if the guidance came into effect from 1 January 2009, as proposed by the FDA.

Applying prefatory language on adverse event reporting in combination with the company's address on the label would be undesirable because it would suggest that was the main purpose the contact details served, said Shao.

"Consumers may want to contact the firm to praise the performance of the product, ask questions, or provide feedback on some attribute of the product. Product labels serve many other purposes and it is unreasonable to highlight adverse events as the sole, or at least the primary, reason to contact the company."

Shao said the CRN objected to FDA's attempt to impose the recommendations through guidance rather than usual procedures for label changes. And although the FDA said in its draft guidance that the recommendations were not mandatory, it used language in the document which suggested otherwise.

But even if the guidance was not to be mandatory, companies would be ill-advised to ignore it because if they did this could be used against them in civil litigation, Shao said.

"In effect, then, new labelling requirements that represent a departure from longstanding FDA regulations have a substantial and mandatory effect that should only be achieved through notice and comment rulemaking," he said. "For the Agency to naively suggest that it is only making 'recommendations' to industry is disingenuous at best."

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