In brief, during the past 10 days the Food and Drug Administration has issued two major Guidance documents that affect the natural products industry: the first about how to label dietary supplements to comply with the requirement to report a serious adverse event (SAE), and the second about how to report a shipment of contaminated food via the FDA’s new “electronic portal.”
As a general legal matter, it is important to keep in mind that an agency guidance document is not as strong as a law or a regulation. In fact, at the beginning, the FDA declares “Contains Nonbinding Recommendations.” Then, in most guidances, there is the following disclaimer:
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. [emphasis added]
Thus, a different approach that is consistent with the spirit of the recommendations is certainly possible. The non-binding nature of a guidance is especially important for some recommendations in the first guidance discussed in this Briefs report, concerning supplement labeling telling consumers how to report a serious AE.
The most controversial part of the dietary supplement SAER Final Guidance is an added recommendation that “the label also bear a clear, prominent statement informing consumers that they may report serious adverse events to the domestic address or domestic phone number on the label.” Also, in a new suggestion, FDA states that this recommended “signal statement” may contain an added phrase: “the responsible person can also clarify that a doctor should be called for medical advice.” As an example, the guidance offers the following dual-purpose label statement: “You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact. …”
Logically, the signal language re. AERs and the model language adding “Call a doctor if. . . .” are-- in practical terms-- completely unnecessary. Of course, a consumer with a serious adverse event will call a doctor, or even an ambulance in the most serious cases. If the action of calling a doctor needs to be suggested, then (in a real case scenario) the event can't be truly serious!
Some industry groups have noted that this additional signal and doctor suggested language is certainly not required in supplement labeling; and the American Herbal Products Association has observed that its specificity may indeed be premature before the agency has initiated formal rulemaking. Note that the Guidance itself states that the industry or other stakeholders may submit comments "at any time." Thus, labelers are not technically required to change the way they meet the SAER requirement; they may simply print the full mailing address after “Distributed by:” and the company name. One phrase that could be added to supplement labels before the address or phone number would be: "For product information contact: . . . . "
The good news is that, for non-binding recommendations, labelers may decide for themselves; the requirement is effective September 30, 2010. This first FDA guidance document discussed, issued on September 1, 2009, is available online at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm179018.htm.
The second important FDA guidance document was issued on September 9, 2009, and applies to foods and “functional foods” though not to dietary supplements. The purpose of the requirement, passed by statute, is to prevent potential foodborne illness, by removing contaminated shipments from the stream of commerce before they reach consumers’ tables. Effective Sept. 8, facilities that manufacture, process or hold food for the consumption in the U.S. must report to the FDA if they find a reasonable probability that an article of food will cause death or severe health problems to either a person or an animal. Food safety hazards that are reportable include bacterial contamination, allergen mislabeling, or certain chemical components present at elevated levels. The “responsible parties” must contact the Reportable Food Registry at FDA—within 24 hours—using: http://rfr.fda.gov. During business hours, more information is available by phone at 1-888-SAFEFOOD. The FDA’s guidance is available at: www.fda.gov/ReportableFoodRegistry.
Compiled by Susan D. Brienza, Esq. (Patton Boggs LLP). For questions, comments, or further information, please write [email protected]