FDA Issues SAER Labeling Guidance, Reaction Mixed

September 1, 2009

The U.S. Food and Drug Administration (FDA) released guidance on August 31, 2009, for dietary supplement labelers recommending that all supplement products bear either a domestic phone number or address on the product label so consumers can more easily report adverse events. The announcement came in the Federal Register, which is the official daily publication for rules, proposed rules and notices from federal agencies and organizations.

Since December 2007, supplement companies have been required to report any serious adverse event reports (SAER) to the FDA within 15 days of receiving the report. The FDA defines serious adverse events as serious, harmful effects or illnesses from dietary supplements. The FDA’s latest guidance marks the third time the agency has published a recommendation for the inclusion of a domestic phone number or address on a product label, which many in the dietary supplement industry oppose. Additionally, the FDA also recommended in its latest guidance that companies include a prominent statement informing consumers that they may report adverse events to the contact information provided and to contact a doctor for medical advice. The FDA used an example of an acceptable label statement that combines the two statements: “You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact…”

Manufacturers and marketers will have until September 30, 2010, to comply with the new labeling guidelines. If the labels do not contain the appropriate contact information after that date, then the products will be considered misbranded, the FDA reported.

The American Herbal Products Association (AHPA) is one industry organization that has raised concerns about the manner in which the FDA has proposed its SAER labeling guidelines. During a comment period in March 2008 regarding the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the Act), AHPA President Michael McGuffin wrote, “The recommended ‘signal language’ proposed for inclusion in the guidance was contrary to the intent of Congress; is not required under the Act; and the issuance of guidance in this manner constitutes rulemaking without notice and comment.”

On September 1, 2009, McGuffin expressed disappointment with the new guidance and cautioned that companies ought to further evaluate their legal responsibilities. “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,” McGuffin said in a prepared statement. “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.”

The new SAER rule has been in the spotlight since the FDA received more than 20 adverse event reports from consumers who had developed health problems associated with the use of the popular weight-loss supplement Hydroxycut. The brand’s maker, Iovate Health Sciences, pulled 14 Hydroxycut products from the market after the agency warned consumers in May 2009 not to use the products given the adverse event reports. Loren Israelsen, executive director of the United Natural Products Alliance, told NBJ that he sees the FDA’s Hydroxycut warning and Iovate’s subsequent recall as examples of the SAER law working as it should. With this law now in place, “FDA has authority to move faster and gain access to more records,” Israelsen said. “GMPs are fully coming into effect shortly, and when an episode like this happens—and all industries have such events—the tools are available to investigate and resolve the matter as quickly as possible.”

The FDA invites companies to submit written or electronic comments on its Website.

Related NBJ Links:
Hamburg: FDA Will Act Swiftly and Aggressively to Protect Public
FDA Increases Enforcement Efforts, Warns Internet Marketers About Swine Flu Claims
GMP Q&A with CFSAN’s Brad Williams

Related Functional Ingredients Magazine Links:
FDA provides some answers on adverse reporting

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.