The Dietary Supplement and Nonprescription Drug Consumer Protection Act - also known as the serious adverse event reporting bill - was signed into law in December 2006 and came into effect one year later. In the architectural stages it had strong support for many in the industry, who saw it as extra post-market precautionary measure to secure more credibility for supplement makers.

The FDA issued two draft guidance documents on the law on January 2, which it said were intended to assist the industry.

However the American Herbal Products Association (AHPA), which this week submitted comments under the 90 day comment period, has said that the FDA have no statutory requirement to issue this guidance.

It was only required to issue guidance on the minimum data requirements to be included on a label - and that obligation, according to AHPA, was already met in earlier guidance issued in October 2007.

In particular, AHPA is concerned about the recommendation that labels bear a "clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associate with use of this product."

Michael McGuffin, president of AHPA, said this actually runs counter to the intention of Congress.

"Congress explicitly declared that no additional statements would be necessary on labels other than the address or phone number."

The trade organization says that the two additional documents are represented as requirements under the Act - and it does not agree.

"AHPA believes that FDA has described information in these drafts that 'must be included on the label' of these products that is not required by the Act to be so included," it said.

"Further, AHPA believes that FDA has 'recommend[ed]' the inclusion of label information that is not required under the Act."

Thus, it is asking for the documents to be withdrawn in their entirety.

CRN

AHPA's comments follow a similar view in those of the Council for Responsible Nutrition (CRN), which also sent the FDA its feedback this week.

The CRN said it would like the guidance documents to be withdrawn, "or, at a minimum, undergo the normal notice and comment rulemaking process for these interpretations of the Act".

The CRN took issue with use of wording such as "must" and "requires", which it says suggests that "the guidance is not a recommendation at all, but rather a new mandatory requirement for industry."

"Such a change in the absence of a clear Congressional mandate deserves full opportunity for input of all stakeholders that a notice and comment rulemaking would afford," stated the group's vice president of scientific and regulatory affairs Andrew Shao in comments to the FDA.

In addition, FDA's recommendation that prefatory language is used on labels is actually binding to industry because of the impact of civil litigation referencing this guidance language.

If manufacturers choose not to follow FDA recommendations and include a full street address on their labels, then they are in effect creating liability in civil product liability litigation, as failure to follow the guidance would most certainly be introduced into evidence held against the company, said the CRN.

CSPI

The view of the trade associations is at stark loggerheads with that of vociferous consumer watchdog Center for Science in the Public Interest.

Last September the organisation wrote to the FDA that companies "must" provide a complete mailing address rather than just the city and state in which they are located.

"The FDA is depending on the public to report adverse reactions, but without a clear label statement alerting consumers to call or write, it is possible that many adverse reactions may never be reported and the FDA will not have the data it needs to protect the public from dangerous products," said Bruce Silverglade, CSPI's director of legal affairs.

The FDA was already in the process of drawing up its guidance drafts at that time.