Herbalife asks FDA to temper its position that every supplement product containing a new dietary ingredient require a full notification, instead proposing a streamlined process based around NDI master files.

The approach would pressure ingredient suppliers to play a larger role in providing information about products to help their customers comply with the agency’s NDI notification expectations.

Once submitted, an ingredient master file would contain ingredient specifications and safety data on which subsequent notifications for products using that ingredient could be based, Herbalife says in Oct. 13 comments to the agency on the NDI notification draft guidance.

The Los Angeles multi-level marketer of supplements and personal care products appears to prefer a conciliatory approach to address a point of contention in the draft guidance – whether the Dietary Supplement Health and Education Act intended NDI notifications to cover ingredients or finished supplement products (Also see "FDA NDI Notification Draft Guidance Contradicts Final Rule – Ullman" - Pink Sheet, 15 August, 2011.).

Herbalife says the NDI master file approach would “encourage suppliers to invest in useful scientific research substantiating the safety of their ingredients.”

The master file system could help avoid duplicative full NDI notifications for different finished products using the same ingredient or identical products from a single contract manufacturer, Herbalife says.

“Subsequent NDI notifications for supplement compositions relying in part upon the same ingredients would refer to the relevant master files and would not need to include additional safety data about the referenced ingredient,” the company says.

To protect proprietary formulation data, Herbalife recommends FDA make public only a file number and unique descriptive title for each master file.

Herbalife says the master file approach would ease the economic burden of NDI notifications on finished product marketers and “encourage suppliers to invest in useful scientific research substantiating the safety of their ingredients.”

Food and drug attorney Marc Ullman has criticized the draft guidance’s provision that a manufacturer need not file an NDI notification as long as “the new supplement does not have other dietary ingredients that were not included in your original NDI notification.”

Ullman says the guidance represents a “drastic change” in DSHEA’s NDI paradigm, which he says mandated a one-time notification for an NDI rather than notifications for all new formulations including it.

Commenting Outside The Trade Groups

With the deadline for public comments on the draft guidance recently extended until Dec. 2, Herbalife put in its two cents early.

Though the supplement trade associations seek to present a unified industry front to FDA, individual companies likely want to offer their own unfiltered positions (Also see "Jarrow Formulas Founder Forms “More Creative” Supplement Trade Group" - Pink Sheet, 10 October, 2011.).

Herbalife is a member of the American Herbal Products Association, Council for Responsible Nutrition and Natural Products Association, and the firm has shared its comments with all three groups, said John Venardos, senior VP of worldwide regulatory government and industry affairs.

In its letter to FDA, Herbalife suggests the agency host a repository of industry-submitted substantiation documents for “old” dietary ingredients, grandfathered in before DSHEA was passed in 1994. Some trade groups maintain their own dietary ingredient databases, but this proposal would shift the burden of keeping an authoritative list of grandfathered ingredients onto the agency.

However, FDA says in its draft guidance there is no definitive list of old dietary ingredients and “the best policy is for any company to maintain its own records confirming long-term use of an ingredient,” making it unlikely the agency would agree to facilitate such a list.

Addressing Non-Botanical Synthetics

Herbalife also questions FDA’s stance on non-botanical synthetically derived ingredients, since the draft guidance mainly addresses synthetics as they relate to botanical substances (Also see "Synthetics Stance In NDI Guidance Raises Red Flag For Industry" - Pink Sheet, 11 July, 2011.).

The guidance is not explicit about FDA’s stance on metabolites such as synthetically produced L-carnitine, “and industry, as a result, is concerned about uncertain treatment of non-botanical synthetics,” Herbalife says.

FDA does say in the guidance that a metabolite of a dietary ingredient, derived by enzymatic or synthetic processing, can itself qualify as a dietary ingredient.

Finally, Herbalife asks the agency to revise the guidance to clarify its exemption standard for NDIs with a history of use in conventional foods, and to delineate the sections of NDI notification filings that FDA considers commercial trade secrets, as a means of protecting intellectual property.

By Dan Schiff

Herbalife Proposes FDA Use NDI Master Files To Reduce Notification Burden

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