Adverse Events Reporting (AER) Act for dietary supplements and other botanicals

Adverse events reporting on botanicals
Article on the Adverse Events Reporting Act for dietary supplements and other botanicals.
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http://abc.herbalgram.org/site/PageServer?pagename=05_01_AER_Labeling_Guidance
FDA Publishes Draft Guidance on Labeling Requirements of AER Act

The US Food and Drug Administration (FDA) announced in the FederalRegister on January 2 that it has issued a draft guidance to assist thedietary supplement industry in complying with the labeling requirementsof the Dietary Supplement and Nonprescription Drug Consumer ProtectionAct ("the AER Act").1 The AER Act requires marketers of dietarysupplements and over-the-counter (OTC) drugs to maintain records of alladverse events reported to the manufacturer and submit reports to theFDA of those incidents meeting the definition of "serious" adverseevents. Comments regarding this draft guidance must be submitted to theFDA by March 3.
According to the draft guidance, dietary supplement labels must includea domestic address or phone number for receiving adverse event reports.The FDA has concluded that this entails either a full US mailing address(complete with street address or post office box number) or a phonenumber with an area code. The FDA further recommends in its guidancethat all dietary supplement labels include a clear, prominent statementinforming consumers that the domestic address or phone number may beused for reporting serious adverse events associated with the product.Although the AER Act went into effect in December of 2007, the FDA hasstated that it intends to exercise enforcement discretion for the newlabeling requirements until January 1, 2009. The requirement to documentadverse events and report serious events to the FDA is currently inforce as of December 22, 2007.
Two prominent industry trade organizations have already expressed someconcerns about the recently issued guidance. The American HerbalProducts Association (AHPA) recently stated in a press release that ithas previously gone on record as arguing that a full US mailing addressis unnecessary for product labels.2 AHPA pointed out that long-standingregulations for foods, drugs, medical devices, and cosmetics have heldthat a company's place of business need not include a street address ifit can be found in a city directory. According to AHPA, FDA explainedthat it has suggested a full mailing address because the agency believesconsumers may choose to not submit a report if they believe it would notbe received due to an incomplete address.
"This is really quite stunning," stated AHPA President Michael McGuffin,according to the AHPA press release.2 "If FDA is stating that theinformation that has been required on food, drug, medical device andcosmetic labeling since 1938 is somehow inadequate to communicate toconsumers, AHPA assumes that FDA would seek a global change in the lawto address any perceived inadequacy and would not single out thisindustry and the OTC drug industry as targets for its hypothesis."
AHPA also objected to FDA's recommendation that companies include astatement about the use of the address or phone number for submittingserious adverse event reports, which AHPA argued "must be seen as awarning statement."
"This was not the intent of the law, and the Senate Committee on Health,Education, Labor and Pensions clearly stated in its official report onthis bill that it 'does not require the label to make any statementother than providing the address or phone number,'" said McGuffin.2
The Council for Responsible Nutrition (CRN) has also recently expresseddisappointment with the guidance document, arguing that it too haspreviously gone on record as opposing such changes in labeling.
"We are dismayed that FDA has introduced these new labelingrequirements, seemingly out of nowhere, particularly because there is nolegislative authority in the statute for these requirements," said SteveMister, president and CEO of CRN (e-mail, January 10, 2008). "It'sparticularly troubling that the agency has chosen to try to impose theserequirements through a draft guidance. These kinds of sweepingdeviations from the stated intent of Congress at least require fullnotice and comment rulemaking."
CRN first learned of FDA officials' interest in changing the labels inthe wake of the passage of the AER law last spring, Mister said.
In a letter sent to Robert E. Brackett, PhD, then-director of the Centerfor Food Safety and Applied Nutrition at the FDA in July of 2007, CRNargued then against both the perceived necessity of a full mailingaddress and of adding a statement about the address and phone number'suse for reporting serious adverse events, for reasons similar to thosegiven by AHPA.3
"The primary purpose of this legislation has always been to assureconsumers that when a company receives a complaint of a serious adverseevent, it will provide that information to FDA. The agency has pastedits own agenda onto the intent of Congress and tried to do so withoutusing the proper administrative procedures," said Mister.
CRN further commented that such label changes would place an undueburden on industry and that manufacturers would need at least 3 years tochange labels on new products being placed on the market.
"We have heard from several of our members that FDA has farunderestimated the financial projections for manufacturers to revisetheir labels," said Mister. "The agency doesn't seem to appreciate thetime and expense involved to make even minor changes to supplementlabeling. Someone, potentially consumers, will have to absorb thesecosts. The agency should reevaluate whether these mandatory changeswould really best serve consumers given these added costs."
The FDA released a prior guidance document in October of 2007 concerningthe submission and recordkeeping of serious adverse events of dietarysupplements and OTC drugs required under the AER Act.4 An articlecovering this guidance document was published in the October issue ofHerbalEGram.5
-Courtney Cavaliere

References1US Food and Drug Administration. Draft guidance for industry: questionsand answers regarding the labeling of dietary supplements as required bythe 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, 2008.2FDA issues labeling guidance on SAER law [press release]. SilverSpring, MD: American Herbal Products Association; January 2, 2008.3Mister S. Letter to RE. Brackett (CFSAN, FDA). July 31, 2007.4US Food and Drug Administration. Draft guidance for industry: Questionsand answers regarding adverse event reporting and recordkeeping fordietary supplements as required by the Dietary Supplement andNonprescription Drug Consumer Protection Act; availability. 72 FederalRegister 58313. October 15, 2007. Available at:http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-5074.pdf. Accessed January 7, 2007.5Cavaliere C. FDA publishes draft guidance on serious adverse eventreports. HerbalEGram. October 2007;4(10). Available at:http://abc.herbalgram.org/site/PageServer?pagename=04_10_SAER_Guidance&JServSessionIdr012=xvjgf745d2.app13a. Accessed January 7, 2008.