A draft guidance issued by the US Food and Drug Administration (FDA) in January of 2008 has recently become the object of intense criticism by dietary supplement trade associations.¹ The draft guidance is intended to assist the dietary supplement indus-try in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (“the AER Act”). The American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the Natu-ral Products Association (NPA) have submitted comments to FDA requesting that the draft guidance be withdrawn.^2,3,4 The AER Act, which went into effect in December of 2007, requires marketers of dietary supplements and over-the-counter (OTC) drugs to maintain records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.

According to the draft guidance, dietary supplement labels must include a domestic address or phone number for receiving adverse event reports.¹ The FDA has concluded that this entails either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 report-ing serious adverse events associated with the product. The FDA stated in the draft guidance that it intends to exercise enforcement discretion for the new labeling requirements until January 1, 2009.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.

In comments submitted to the FDA in March, AHPA pointed out that the FDA had no statutory requirement to issue a draft guidance on the labeling of dietary supplements under the AER Act and that FDA has called for the inclusion of label informa-tion that is not actually required by the Act.² According to AHPA, 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. The FDA explained in the draft guidance that it has suggested a full mailing address because the agency believes consumers may choose to not submit a report if they believe it would not be received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, in an AHPA press release distributed in January.⁵ “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.² In its submitted comments, AHPA stated that this FDA recommendation “blatantly ignores the stated intent of Congress,” as the Senate Committee on Health, Education, Labor, and Pensions clearly expressed its inten-tion to refrain from any statement other than providing the address or phone number. For these and other reasons, AHPA requested that the draft guidance be withdrawn in its entirety.

CRN made arguments similar to those expressed by AHPA in its own comments, also submitted in March.³ Like AHPA, CRN argued that a full mailing address and a prefatory statement would be unnecessary for dietary supplement labels. CRN requested that FDA withdraw the guidance draft or, “at a minimum, undergo the normal notice and comment rulemaking process for these inter-pretations of the Act.”

“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 argued that, despite being presented as recommendations within a guidance draft, the language within the document clearly demonstrates that FDA plans to view many of the recommenda-tions as mandatory requirements that would be enforced.

“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.

NPA sent comments to the FDA in February, also requesting that the guidance draft be withdrawn.⁴ Like AHPA and CRN, NPA pointed out that the AER Act was not intended to require burden-some re-labeling of products and that a full mailing address and a prefatory statement would be unnecessary for dietary supplement labels. NPA even conducted a survey of supplier members before submitting its comments to the FDA to evaluate the effectiveness of current product labels in enabling consumers to file complaints or adverse event reports. According to the survey’s findings, the vast majority of surveyed firms claimed to receive complaints or adverse event reports by phone or e-mail, with a very clear minority citing mail as the most often used form of consumer communica-tion. Such information indicates that there are multiple sufficient channels—including the Internet—by which consumers are able to contact or find contact information about companies, without requiring extensive product label changes.

AHPA, CRN, and NPA all argued that the new recommended label changes would be costly for supplement companies. AHPA pointed out that some companies might already be in compliance with the domestic address recommendation for supplement label-ing, but no supplement labels are likely to currently contain a pref-atory statement about using the phone number or address to report serious adverse events.² Therefore, AHPA has stated that 100% of supplements would need to be relabeled in order to meet this recommendation. CRN added that FDA has also underestimated the amount of time it would take for industry to comply with the new labeling requirements.

The Small Business Association’s (SBA) Office of Advocacy sent a letter to the FDA in February expressing its concerns over the draft guidance, largely due to the costs small dietary supplement companies would incur in order to meet the new labeling recom-mendations.⁶ SBA suggested that the FDA reanalyze the possible effects of these recommendations on the dietary supplement indus-try and consider making the guidance a rulemaking subject to notice and comment.

"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 appre-ciate 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."

At HerbalGram's press time, the FDA had not directly responded to these requests for withdrawal of the draft guidance.

References

1. US Food and Drug Administration. Draft 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. 73 Federal Register 197. January 2, 2008. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getpage. cgi?dbname=2008_register&position=all&page=197. Accessed January 2, 2008.
2. McGuffin M, Young A. Comments of the American Herbal Products Association on the Food and Drug Administration's draft guidance for industry titled “Questions and answers regarding the labeling of dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act” and on the Food and Drug Administration's draft guidance for industry titled “Questions and answers regarding the labeling of nonprescription human drug products marketed without an approved application as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” Docket Nos. 2007D-0491 and 2007D-0496. March 3, 2008.
3. Shao A. Re: Docket No. 2007D-0491, CFSAN 200755. Draft guid-ance for industry: Questions and answers regarding the labeling of dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. March 3, 2008.
4. Fabricant D. Re: Docket No. 2007D-0491, draft guidance for indus-try: Questions and answers regarding the labeling of dietary supple-ments as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. February 27, 2008.
5. FDA issues labeling guidance on SAER law [press release]. Silver Spring, MD: American Herbal Products Association; January 2, 2008.
6. Sullivan TM, Rayford LL. Letter to the Honorable Andrew C. von Eschenbach, MD. February 28, 2008. Available at: http://www.ahpa. org/Portals/0/pdfs/08_0228_SBA_Letter_to_FDA_re_SAER_Guid-ance.pdf. Accessed March 11, 2008.