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HerbalEGram: Volume 6, Number 10, October 2009
FDA Releases Final Guidance on Serious Adverse Event Labeling Requirements for Dietary Supplements
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The US Food and Drug Administration (FDA) announced on September 1 that it has released its final guidance on the labeling requirements for dietary supplements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (“the Act”).1
The Act, which went into effect in December 2007, requires that marketers of dietary supplements submit to the FDA within 15 business days any serious adverse event reports (SAERs) that they have received regarding a product and keep records of those events. The new final guidance document contains information, through a question and answer format, on what should be present on a supplement’s label to ensure that consumers are able to submit SAERs to manufacturers.
The guidance states that dietary supplement labels must include a domestic address (defined as a full US mailing address, with street address or P.O box, city, state, and zip code) or domestic phone number (including area code) for the reporting of SAERs. The guidance document also recommends that labels bear a clear, prominent statement informing consumers that they may report serious adverse events to the address or phone number on the label, although it is written in the guidance that such a statement is not required. These labeling requirements are already in effect, but according to the guidance document, the FDA intends to exercise enforcement discretion for the new labeling requirements until September 30, 2010.
Rick Kingston, PharmD, president of SafetyCall International Poison Center in Minneapolis, stated that the guidance creates a level playing field for those responsible companies that have been producing labeling with sufficient information for the reporting of concerns such as suspected adverse effects. “Prior to this clarification of the labeling requirements, many companies used labeling that simply did not meet the intent of the law,” he said (e-mail, September 22, 2009).
He added that these new labeling requirements will likely not result in a heavy financial burden for many supplement companies. “Given FDA’s indication to allow enforcement discretion into 2010, those companies not currently meeting the requirement will likely have time to change labeling during the course of routine product turnover. Additionally, most responsible manufacturers have typically already had labeling in place that meet both the letter and intent of the law.”
The FDA issued a draft guidance concerning the labeling requirements of the Act in January of 2008, and the public was invited to submit comments. Various trade organizations—including the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA)—were very critical of the draft guidance and requested that it be withdrawn.2 These trade associations commented that the FDA was calling for burdensome and unnecessary label changes and that the FDA’s recommendations in the draft guidance ignored the intent of Congress when it passed the Act. (An article concerning the responses of trade associations to the draft guidance was published in HerbalGram 78, available here.)
Steve Mister, president and CEO of CRN, stated that CRN expects its member companies to be fully compliant with FDA’s requirement to provide a complete US mailing address and/or phone number on product labels by the compliance deadline, even though CRN’s interpretation of the requirements of the Act differ from the FDA’s (e-mail, September 21, 2009).
AHPA President Michael McGuffin likewise said that AHPA encourages its member companies to promptly review labels for inclusion of a domestic phone number or address.3 “At the same time, AHPA continues to have concerns about the short-cut to rulemaking expressed by FDA’s signal language recommendation, and the agency’s unwillingness to accept the clearly stated intent of Congress. Companies may want to consider the limits of their actual legal responsibility when determining whether to adopt FDA’s recommendation for use of this signal language,” he said, referring to the clear, prominent statement on labels about using the address or phone number for the reporting of serious adverse events, suggested by the FDA in the guidance.
“I would be surprised if any company adopted the suggested language, as it appears to imply that consumers should expect to experience serious adverse effects,” said Kingston, noting that the recommended statement would likely have a negative impact on consumer confidence. “I have recommended language that accomplishes the same purpose, such as ‘for questions, comments or concerns, call ..’ and believe many companies have adopted similar language. In the end, both FDA and responsible manufacturers want to support a process that will encourage consumers to share their concerns with the manufacturer so that if an issue arises, it can be properly considered and addressed.”
“CRN is pleased to see that FDA expressly recognizes in this final guidance that the introductory statement on the label prior to the address or phone number is only the Agency’s recommendation—it is not a requirement of the law,” said Mister. “However, CRN is concerned that this is an attempt to get through coercion what the Agency could not obtain through a proper rulemaking. The mere fact that this recommendation appears as part of the final guidance could be easily misconstrued as a requirement by those who don’t fully understand FDA’s authority, whether that be retailers who may misunderstand the recommendation and insist that manufacturers who sell through their stores include prefatory language on their labels, or whether it arises in product liability litigation related to an alleged adverse event in which a manufacturer’s failure to include an introductory statement is used as evidence against it. FDA is fully aware of these implications of including this recommendation in the guidance without conducting a notice and comment rulemaking, and yet it forges ahead without any mandate in the law.”
The final guidance is available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm179018.htm.
A few months ago, the FDA released a final guidance on serious adverse event reporting and recordkeeping required by the Act.4 An article on the release of that final guidance was published in the August issue of HerbalEGram, available here.5
—Courtney Cavaliere
References
1.Food and Drug Administration. Guidance for industry: questions and answers regarding the labeling of dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; availability. 74 Federal Register 168; September 1, 2009.
2.Cavaliere C. Trade associations request withdrawal of FDA’s draft guidance on labeling requirements of AER Act. HerbalGram. 2008;78:58-59.
3.FDA issues final guidance on SAER labeling [press release]. Silver Spring, MD: American Herbal Products Association; September 1, 2009.
4.Food and Drug Administration. Guidance for industry: questions and answers regarding adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; availability. 74 Federal Register 133; July 14, 2009.
5.Cavaliere C. FDA releases final guidance on adverse event reporting and recordkeeping. HerbalEGram. August 2009;6(8). Available at: http://cms.herbalgram.org/heg/volume6/08%20August/FDA_SAER_Guidance.html?t=1248794824.
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