Disappointment as FDA repeats adverse-event labelling demands

Confusion remains over the agency's plans to 'enforce' guidance

Leaders in the supplements supply industry voiced their disappointment after the Food & Drug Administration appeared to ignore their concerns over labelling recommendations in relation to adverse-event reporting (AER). Updated draft guidance on AER labelling, issued by the FDA at the end of last year, stated that supplements suppliers should print a full street address on labels and indicate with prefatory language that this address was specifically for consumers to report adverse events.

This was a repeat of draft guidance issued a year earlier by the FDA, which attracted strong criticism. At the time, the Council for Responsible Nutrition warned that the guidance went further than Congress had intended when it approved the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

This came into force in December 2007, and obliges supplements manufacturers to report serious adverse events to the FDA and to keep a record of less serious events.

In its response, lodged in March 2008, the CRN said that although it supported the act, it believed the FDA guidance was "not stipulated in the act by Congress and is entirely unnecessary."

Almost a year on, Andrew Shao, CRN vice president of scientific and regulatory affairs, told Functional Ingredients: "It appears the FDA did not take into account the industry's comments, since the updated draft guidance is virtually a duplication of the initial draft guidance.

"The same areas of concern remain for CRN. In our comments to the initial draft, we opposed both requirement of the full street address and the prefatory statement. We continue to maintain this position. The concern here is that we do not believe this was the intent of Congress to either require a full street address or a prefatory statement."

In CRN's earlier response to the FDA guidance, which it stands by, the trade body warned that the FDA's guidance could cost the industry at least $300 million in labelling costs. There was also concern that the prefatory language could mean consumers would only use the address to report adverse events, and not to praise a company, give feedback or ask general questions, as they might now.

Separately, Shao said the CRN believed the guidance ran contrary to procedures demanding that mandatory changes to labelling should be implemented only through the process of notice and comment rulemaking.? The FDA has completely ignored this requirement and is essentially implementing regulation through guidance," said Shao. "The rule of thumb is that guidance equals regulation, at least from a liability standpoint."

"One concession to the industry has been the decision by the FDA to extend the deadline for complying with the guidance from January 2009 to January 2010. But confusion over the FDA's use of terminology remained, said Shao. "The FDA says that it will 'begin enforcement and requirement' in January 2010. However, 'guidance' is not enforceable, so there seems to be a bit of a disconnect here. We're unclear at this time what this means."

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