In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs.

While industry trade groups hotly contested both points in the draft guidance, they appear resigned to accept FDA's interpretation of the address requirement of the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The 2006 law mandates supplement and OTC labels include a phone number or a domestic address for AER reporting.

However, the groups emphasize the law does not require firms to include an introductory statement directing users to submit AERs to the point of contact, despite FDA's recommendation.

Firms that have not changed their labels yet have until Sept. 30, 2010. FDA said it pushed back the enforcement date nine months because of the delay in publishing the final guidance.

Both the supplement ¹ guidance and the OTC drug ² guidance recommend labels "bear a clear, prominent statement informing consumers that they may report serious adverse events to the domestic address or domestic phone number," so consumers can understand why the label includes the address.

American Herbal Products Association President Michael McGuffin says the recommendation directly contravenes the intention of Congress.

He noted, "Congress clearly stated unambiguously [that] this legislation does not require the label to make any statement other than provide the address or phone number. Period. Done."

Even FDA acknowledges in the third and final version of the AER labeling guidances for OTC drugs and supplements that the law does not require a label to include anything other than a domestic address or domestic phone number.

But the agency recommends drug makers explain the address in a simple statement that says, "You may report serious side effects to" and either insert the phone number, the address or a reference to the number provided elsewhere on the label.

FDA notes firms also can include other information in the introductory statement.

In this case, FDA recommends the statement say: "You should call your doctor for medical advice about serious averse events. To report a serious averse event or obtain product information, contact..." followed by the phone number or address.

McGuffin said this suggestion makes the statement even less palatable, because the "new line" about the doctor appears to be "an attempt by FDA to place a third-party health care provider between the consumer and their dietary supplements."

With this in mind, AHPA will advise its members that legally they are not required to include an introductory statement on labels and will encourage them to discuss the matter with their attorneys.

Guidance As Rulemaking?

The trade groups complain FDA should have used the rulemaking process instead of guidance to define "domestic address" and to propose the introductory statement.

The Council for Responsible Nutrition says calling for the prefatory statement in guidance "is an attempt to get through coercion what the agency could not obtain through a proper rulemaking."

McGuffin agreed, noting, "To pretend this is not rulemaking is disingenuous and inconsistent with the current administration's attempt to make us believe they like transparency in government." He added that the guidance "doesn't feel transparent."

Trade groups asked the recently created Transparency Task Force how FDA decided to define "domestic address" in the law as a three-line address (³ Also see "Drug, Supplement Industries Need Formal But Timely Guidance - Stakeholders" - Pink Sheet, 17 August, 2009.).

CRN and the Natural Products Association also worry the guidance could confuse firms or trigger legal action.

"The mere fact that this recommendation appears as part of the final guidance could be easily misconstrued as a requirement by those who don't fully understand FDA's authority," CRN explains.

For example, retailers may not understand the prefatory language is voluntary and could insist firms include it on their labels, CRN says.

Misunderstandings about the statement also "could give way to bounty-hunter-type suits similar to what we see with Prop 65 in California," said NPA Interim Executive Director Daniel Fabricant.

The lack of prefatory statement also could be used against firms in product liability suits, CRN warns.

"Domestic Address" Vs. "Place Of Business"

Including the full address and phone number is not optional, the trade groups acknowledge. FDA defines a domestic address, required by the law, as a full U.S. mailing address with the street number or P.O. box.

FDA argues, "An address does not serve its intended purpose unless it includes all the information necessary to enable mail to reach its destination."

The agency maintains that "if Congress had considered the less complete address already required under the 'place of business' labeling regulation to be adequate for serious adverse event reporting, there would have been no need to impose a new, more specific requirement ... for the responsible person's 'domestic address' to appear on" labels.

Prior to the AER law, the Food, Drug and Cosmetic Act required firms include on labels their "place of business," which is defined as only the firm's city, state and zip code, as long as the firm's street address is in a directory.

Changing labels to include a street address or P.O. box "is a huge cost to industry," Fabricant said (⁴ Also see "FDA Estimates Dollar Costs For Adverse Event Labeling But Doubts Persist" - Pink Sheet, 2 March, 2009.).

However, the cost may be mitigated somewhat because many firms changed their labels in anticipation of the final guidance following the release of draft guidance in December 2007 and December 2008 (⁵ Also see "AER Label Guidance Holds To Requiring Full Addresses For OTCs, Supplements" - Pink Sheet, 15 December, 2008. and ⁶ Also see "Return To Sender, Industry Groups Say Of AER Address Guidance" - Pink Sheet, 7 January, 2008.).

McGuffin estimates 75 percent of AHPA members include a full address or phone number on their labels, and CRN said many of its members already changed their labels.

- Elizabeth Crawford ( ⁷ e.crawford@elsevier.com )

Final AER Guidance Requires Full Address, Recommends Prefatory Language

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