|
|
|
|
|
HerbalEGram: Volume 6, Number 1, January 2009
FDA Extends Deadline for Industry to Comply with
AER Labeling Requirements For Dietary Supplements
|
The US Food and Drug Administration (FDA) announced in a Federal Register notice on December 11 that it will not begin enforcing labeling requirements related to the Dietary Supplement and Nonprescription Drug Consumer Protection Act (“the AER Act”) until January 1, 2010. This new deadline is a year later than the agency’s original deadline.1,2
The FDA released 2 draft guidance documents in January 2008 (one for dietary supplements and one for nonprescription drugs) that provided information on purported labeling requirements of the Act. According to those draft guidance documents, the FDA concluded that manufacturers of dietary supplements and nonprescription (aka over-the-counter, or OTC) drugs would need to include a full mailing address or phone number with area code on product labels, as well as a clear and prominent statement informing consumers that the address or phone number may be used for filing serious adverse event reports (SAERs) associated with the product. Several dietary supplement trade organizations requested the withdrawal of the draft guidance documents, arguing that such requirements would be unnecessary, were not intended by Congress, and could necessitate costly label changes for companies. These organizations included the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA).3
The agency has stated that it has extended the deadline for complying to the labeling requirements of the guidance documents because the FDA is still in the process of finalizing the guidance[s].1
Michael McGuffin, president of AHPA, released the following statement in a press release: “AHPA supports FDA’s decision to extend the deadline to comply with these purported requirements. However, FDA had no statutory requirement to issue these documents under this good law, and we maintain our position that FDA should withdraw the AER labeling guidances for over-the-counter drugs and dietary supplements.”2
“It looks like we’re back to square one,” said Daniel Fabricant, PhD, NPA’s vice president of scientific and regulatory affairs (oral communication, January 5, 2009). Dr. Fabricant noted that industry members and the public once again have the ability to submit comments to the FDA regarding the AER labeling guidance documents. NPA intends to submit comments again, which Dr. Fabricant stated will be similar to the comments that the organization sent to FDA previously. “The same issues are still there, particularly the financial implications as well as the intent of Congress,” said Dr. Fabricant. “There’s still a bit of work to be done between the agency and the supplement industry to reach a reasonable solution.”
Dr. Fabricant added that NPA will again address in its comments that the FDA’s labeling draft guidance document must go through the Office of Management and Budget (OMB). In October 2008, the agency submitted a notice to OMB acknowledging that it had underestimated the number of dietary supplement stockkeeping units (SKUs) that would have to be re-labeled under the proposed labeling requirements. In the agency’s labeling draft guidance document, the FDA estimated that 22,574 SKUs for dietary supplements would have to conform to label changes, but the FDA revised this to 55,600 SKUs in its notice to OMB (making the total estimated cost for relabeling dietary supplements $222,400,000); however, that October notice was withdrawn the same day it was posted.
Andrew Shao, PhD, vice president of scientific and regulatory affairs for CRN, likewise noted that CRN still has the same concerns regarding the draft guidance that the organization expressed earlier. “In our comments to the initial draft, CRN opposed both requirement of the full street address and the prefatory statement—we continue to maintain this position,” said Dr. Shao (e-mail, January 5, 2009). “The concern here is that we do not believe this was the intent of Congress (to either require a full street address or a prefatory statement). This is separate from the point that mandatory changes to labeling should be implemented through the process of notice and comment rulemaking. FDA has completely ignored this procedural requirement and is essentially implementing regulation through guidance.”
Dr. Shao added that some dietary supplement companies have already begun to add full phone numbers and mailing addresses to their labels, to potentially prepare for the labeling requirements proposed in the guidance documents. “The rule of thumb is ‘guidance = regulation,’ at least from a liability standpoint. Because of that, many companies have already initiated changes to their labels to reflect the full street address of the manufacturer,” said Dr. Shao.
CRN has not yet officially responded to the “revised” draft guidance with extended compliance deadline, primarily since the Federal Register notice did not supply a deadline for submitting comments. If the organization does submit comments, Shao said that CRN will likely reiterate the same arguments that were submitted to the initial draft guidance.
The AER Act, which went into effect in December 2007, was supported by the major dietary supplement trade associations, as well as the OTC drug industry. The Act requires marketers of dietary supplements and 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.3
—Courtney Cavaliere
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: revision 1; availability. 73 Federal Register 239; December 11, 2008. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-29301.pdf. Accessed December 22, 2008.
2. FDA extends AER label compliance deadline by one year. AHPA Update. December 9, 2008. American Herbal Products Association Web site. Available at: http://www.ahpa.org/Default.aspx?tabid=69&aId=498&zId=1. Accessed December 9, 2008.
3. Cavaliere C. Trade associations request withdrawal of FDA’s draft guidance on labeling requirements of AER Act. HerbalGram. 2008;78:58-59.
|
|
|
|
|
|
|
|