HerbalEGram: Volume 5, Number 1, January 2008

The US Food and Drug Administration (FDA) announced in the Federal Register on January 2 that it has issued a draft guidance to assist the dietary supplement industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (“the AER Act”).¹ The AER Act requires marketers of dietary supplements and over-the-counter (OTC) drugs to maintain records of all adverse events reported to the manufacturer and submit reports to the FDA of those incidents meeting the definition of “serious” adverse events. Comments regarding this draft guidance must be submitted to the FDA by March 3. 

According to the draft guidance, dietary supplement labels must include a domestic address or phone number for receiving adverse event reports. The FDA has concluded that this entails either a full US mailing address (complete with street address or post office box number) or a phone number with an area code. The FDA further recommends in its guidance that all dietary supplement labels include a clear, prominent statement informing consumers that the domestic address or phone number may be used for reporting serious adverse events associated with the product. Although the AER Act went into effect in December of 2007, the FDA has stated that it intends to exercise enforcement discretion for the new labeling requirements until January 1, 2009. The requirement to document adverse events and report serious events to the FDA is currently in force as of December 22, 2007.

Two prominent industry trade organizations have already expressed some concerns about the recently issued guidance. The American Herbal Products Association (AHPA) recently stated in a press release that it has previously gone on record as arguing that a full US mailing address is unnecessary for product labels.² AHPA pointed out that long-standing regulations for foods, drugs, medical devices, and cosmetics have held that a company’s place of business need not include a street address if it can be found in a city directory. According to AHPA, FDA explained that it has suggested a full mailing address because the agency believes consumers may choose to not submit a report if they believe it would not be received due to an incomplete address.

“This is really quite stunning,” stated AHPA President Michael McGuffin, according to the AHPA press release.² “If FDA is stating that the information that has been required on food, drug, medical device and cosmetic labeling since 1938 is somehow inadequate to communicate to consumers, AHPA assumes that FDA would seek a global change in the law to address any perceived inadequacy and would not single out this industry and the OTC drug industry as targets for its hypothesis.”

AHPA also objected to FDA’s recommendation that companies include a statement about the use of the address or phone number for submitting serious adverse event reports, which AHPA argued “must be seen as a warning statement.”

“This was not the intent of the law, and the Senate Committee on Health, Education, Labor and Pensions clearly stated in its official report on this bill that it ‘does not require the label to make any statement other than providing the address or phone number,’” said McGuffin.²

The Council for Responsible Nutrition (CRN) has also recently expressed disappointment with the guidance document, arguing that it too has previously gone on record as opposing such changes in labeling.

“We are dismayed that FDA has introduced these new labeling requirements, seemingly out of nowhere, particularly because there is no legislative authority in the statute for these requirements,” said Steve Mister, president and CEO of CRN (e-mail, January 10, 2008). “It’s particularly troubling that the agency has chosen to try to impose these requirements through a draft guidance. These kinds of sweeping deviations from the stated intent of Congress at least require full notice and comment rulemaking.”

CRN first learned of FDA officials’ interest in changing the labels in the wake of the passage of the AER law last spring, Mister said.

In a letter sent to Robert E. Brackett, PhD, then-director of the Center for Food Safety and Applied Nutrition at the FDA in July of 2007, CRN argued then against both the perceived necessity of a full mailing address and of adding a statement about the address and phone number’s use for reporting serious adverse events, for reasons similar to those given by AHPA.³

“The primary purpose of this legislation has always been to assure consumers that when a company receives a complaint of a serious adverse event, it will provide that information to FDA. The agency has pasted its own agenda onto the intent of Congress and tried to do so without using the proper administrative procedures,” said Mister.

CRN further commented that such label changes would place an undue burden on industry and that manufacturers would need at least 3 years to change labels on new products being placed on the market.

“We have heard from several of our members that FDA has far underestimated the financial projections for manufacturers to revise their labels,” said Mister. “The agency doesn’t seem to appreciate the time and expense involved to make even minor changes to supplement labeling. Someone, potentially consumers, will have to absorb these costs. The agency should reevaluate whether these mandatory changes would really best serve consumers given these added costs.”

The FDA released a prior guidance document in October of 2007 concerning the submission and recordkeeping of serious adverse events of dietary supplements and OTC drugs required under the AER Act.⁴ An article covering this guidance document was published in the October issue of HerbalEGram.⁵

—Courtney Cavaliere

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