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FDA listens to industry, extends CAM guidance comment period

By Clarisse Douaud, 24-May-2007

Related topics: Regulation

The US Food & Drug Administration (FDA) has extended the comment period on its draft CAM products guidance following widespread confusion relating to the document.

The American Herbal Products Association (AHPA) recently asked FDA to extend the comment period for the guidance entitled, Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. The Council for Responsible Nutrition (CRN) also spoke out again the guidance as giving misinformation on what products could in fact constitute drugs.

 

 

 

In its most recent announcement, the FDA acknowledged the confusion surrounding the document and its intended purpose, and also admitted to previous errors in publicizing differing projections of the length of the comment period.

 

 

 

"Public concern based on misinterpretations of the draft guidance has generated a large volume of comments to the docket," FDA announced in its notice in the Federal Register. "The large volume of comments has impeded our ability to identify and respond to extension requests."

 

 

 

As such, the federal agency said it is extending the public comment period from April 30 to May 29. The length of the comment period, which began in February, was called into question too because FDA's Federal Register originally stated it would last for 90 days.

 

 

 

"Ours was a simple request, to ensure the public has sufficient time to respond to this draft guidance document," said AHPA president Michael McGuffin. "The comment deadline error and the draft guidance itself have generated significant confusion and concern."

 

 

FDA has again underscored that the CAM guidance is meant to be a point of reference and neither contains nor proposes and any regulatory changes for any CAM products marketed in the US.

 

 

 

"We are aware of considerable confusion about the content of the draft guidance, which has been widely misinterpreted," says FDA's notice.

 

 

 

AHPA had also previously called on FDA to withdraw the entire CAM draft guidance - saying it would only breed more misunderstanding in the industry.

 

 

 

Of primary concern to CRN was the omission of qualifying language relating to how dietary supplements are excluded from being a "drug" as defined in the Federal Food, Drug, and Cosmetic Act (FD&CA).

 

 

 

For instance, CRN said the guidance's definition of a drug excludes section 403 (r) of the Act, which outlines how a food or dietary supplement with an FDA-approved health or structure/function claim is not a drug.

 

 

 

In addition, CRN urged that the draft guidance include information on FDA-approved health claims and qualified health claims in its discussion of dietary supplements. Health claims are playing an increasingly crucial role for dietary supplement marketing and research.

 

 

 

FDA states in the Federal Register that any previously submitted comments on the CAM guidance do not need to be resubmitted.

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