Firms "rarely" will meet the scientific rationale FDA included in an interim final rule to substantiate petitions for exemption from 100 percent ingredient identity testing required in the dietary supplement good manufacturing practices, according to food and drug law expert Scott Bass.

"My prediction is that many firms will decide to file, but that the articulated scientific criteria will rarely be met," Bass, an attorney with Washington-based Sidley Austin, stated in an e-mail to "The Tan Sheet."

The ¹ IFR, published simultaneously with the dietary supplement GMP ² final rule on June 25, permits companies to petition FDA for exemption from the requirement for 100 percent identity testing of dietary ingredients (³ Also see "Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing" - Pink Sheet, 25 June, 2007., p. 3).

To have petitions granted, firms will have to provide scientific rationale "to establish that there is no material diminution of assure of the identity of the ingredients, compared to the assurance provided by 100 percent identity testing," the rule says.

The IFR does not provide specific guidelines on information to include in exemption petitions. In the IFR's economic analysis, however, FDA says it will "assume" petitions would include "one-year's identity testing results, a verification testing plan and a supplier risk evaluation."

The IFR's stringent scientific requirements to ensure ingredient quality could provide an advantage for firms producing high quality supplements, according to industry attorney Marc Ullman.

The rule may be "an opportunity for high quality suppliers and their customers, who pay a premium for high quality product, to get some relief from expensive testing requirements," Ullman said during the American Herbal Products Association's GMP teleconference July 12.

"It provides a vehicle in which dietary ingredient suppliers that are reliable, that produce consistent products, can help their customers - the manufacturers of the dietary supplements - alleviate some of the burden and cost involved in the 100 percent identity testing requirement in final rule," added Ullman, of New York-based Ullman, Shapiro and Ullman.

In addition to being geared toward high quality supplement firms, the rule would be the most cost-effective for large firms, or "firms that receive 100 lots or greater for a particular ingredient per year," FDA states.

Since the GMP rule was published, industry experts and FDA officials have discussed the regulations and their potential impacts on dietary supplement businesses during seminars sponsored by the Council for Responsible Nutrition and the Natural Products Association as well as AHPA (⁴ Also see "“Upstream Pressure” Can Ensure Suppliers Are GMP Partners – Bass" - Pink Sheet, 16 July, 2007., p. 3).

Several speakers point out FDA clarifies in the rule that exemption from identity testing covers only a specific ingredient from a specific supplier.

Additionally, "if a supplier is switched ... it requires a new petition," Kevin Boot, regulatory counsel for supplement ingredient supplier Embria Health Sciences, said during CRN's GMP seminar July 16.

Boot added "the rule went further" to explain "as part of ... occasional identity testing, however that's been established by the manufacturer's quality unit, if that testing shows that identity is not met, then the exemption ends."

FDA also will be examining available data besides the information provided in a petition to determine whether firms will be exempt from the testing requirements.

"This IFR right now only contemplates petitions being filed by a manufacturer, but material from petitions filed by different manufacturers will be used to assist FDA in determining how it's going to rule on individual dietary ingredient suppliers," Ullman said.

Additionally, the IFR states FDA will not accept any petitions until GMP compliance is mandated, but "that does not mean that you can't start this identity testing in advance of the date that FDA would be willing to consider the petition that you're filing," Ullman added.

The largest supplement firms must be in compliance by June 24, 2008, while the smallest firms have until June 2010, according to the final rule.

The IFR goes into effect Aug. 27, but FDA invites industry to submit comments by Sept. 24, after which it will be issuing a guidance on the regulation.

- Jessica Lake (j.lake@elsevier.com)

GMP Interim Final Rule Sets Bar High For 100% Testing Exemption – Experts

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