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December 15, 2000

3 Min Read
FDA Extends Comment Period on OTC Botanical Drugs

WASHINGTON--The Food and Drug Administration (FDA) is extending to March 15, 2001, its comment period for the draft guidance on botanical drug products; the reopening of the comment period was published in the Dec. 15 Federal Register.

The guidance was originally published in the Aug. 11 Federal Register and outlines the circumstances that define when a botanical drug product qualifies for either a new drug application (NDA) or an over-the-counter (OTC) drug monograph. (For details on the original guidance, see www.naturalproductsinsider.com/hotnews/08h1115540.html.)

According to FDA, the guidance introduced several new and technical issues. The agency also received a request from the law firm Sidley & Austin, on behalf of an unidentified Asian research company, to extend the comment period.

Diane McEnroe, an attorney at Sidley & Austin, stated that a better system for herbal drug products is needed. She added that the main focus behind this petition is to open discussion for establishing a new category of products that have a different regulatory system than what is proposed in the guidance. According to McEnroe, the aim of this petition is to open the door into making health claims more aggressive without having to go through the entire NDA process.

Under the guidance, FDA determined that botanicals not generally recognized as safe (GRAS) must be approved using an NDA that includes clinical studies, safety data and chemistry information. In particular, the guidance provides information on how the agency will interpret and apply certain provisions of existing regulations on the submission of investigations on new drug applications.

"This petition may open up a possible avenue to make arguments to support something that everybody in the [dietary supplement] industry wants to see--a special category of herbal and botanical products that are sold as drugs but do not have to be raised to the level of an NDA or even some of the OTC drugs," McEnroe stated. "They would have a [more] streamlined process." For example, McEnroe suggested that botanicals such as echinacea and St. John's wort with proven health benefits should be able to have more leeway in their health claims.

On the other hand, a more streamlined process that creates the opportunity for more detailed structure/function claims may lead to proprietary botanical products. "An OTC monograph is difficult to be patented that would preclude other people, but I think that there will be certain formulations that our client will request patents for," McEnroe said, adding that it may be difficult to patent something that comes from nature. "However, if you create a proprietary blend of herbs, I think FDA has recognized that it will get some type of protection," McEnroe said.

The Consumer Healthcare Products Association (CHPA) filed comments in the original comment period agreeing with FDA's decision to have manufacturers use this guide when seeking NDA approval for nonprescription or prescription botanical drugs. CHPA also stated that the agency should consider developing a similar guidance for non-botanical dietary supplements, such as amino acids from non-botanical sources and vitamins and minerals.

Submit written comments about the guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For the Federal Register record, visit www.fda.gov/cder/~guidance/1221dft.pdf.

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