Some smaller dietary supplement firms could need support from the industry and flexibility from FDA to pay for complying with good manufacturing practices and still keep their doors open.

At the Natural Products Expo West in Anaheim, Calif., March 7, Brad Williams, of FDA's Center for Food Safety and Applied Nutrition, acknowledged the "painful" economic truths for smaller firms, which are required to be in compliance with GMPs starting in June 2010.

"We're going to lose a certain portion of the industry because of this rule," said Williams, manager of the Division of Dietary Supplement Programs in CFSAN's Office of Nutrition, Labeling and Dietary Supplements.

"But it's important enough to ensure the quality of the product that we have to do this," he added.

In a June 2007 final rule, FDA granted supplement manufacturers with fewer than 20 full-time employees three years to adopt current GMPs. As larger firms have ramped up to meet their GMP deadlines since then, industry stakeholders have voiced concern for the future of small firms (¹ Also see "GMP Final Rule Personnel Requirements Could Squeeze Small Firms" - Pink Sheet, 13 August, 2007., p. 6).

Loren Israelsen, executive director of the United Natural Products Alliance, said those concerns are likely to prove on target. Some tiny companies - especially those providing small quantities of specialty herbal or botanical products to narrow market niches - may feel helpless in the face of eventual GMP inspections, he said in an interview.

"They probably realize that there's no real way, if FDA really came in and put [them] through the ringer ... they would survive," Israelsen said.

However, Israelsen suggested FDA allow small entities to develop standard operating procedures around their ingredient expertise, which would allay significant costs linked to using outside laboratories for identity tests.

Additionally, shifting to a cooperative purchasing and testing model could help small firms to stay afloat, he said. In that way, several companies could leverage lower prices and share testing costs when buying the same ingredient from a single supplier.

For instance, smaller firms could each purchase portions of a single lot of an ingredient and share the costs of testing the larger lot instead of each paying to test their individual purchases.

After mid-sized supplement firms - between 20 and 499 employees - pass through the GMP gauntlet beginning in June, Israelsen said he hopes the industry steps up to enable collective arrangements for smaller players as they prepare for compliance.

Williams emphasized FDA's increased food safety funding in the fiscal 2008 and 2009 appropriations put more inspectors on the ground and enhanced GMP enforcement. "We are quite willing to enforce this rule. This rule is not there as a paper tiger," he said.

He acknowledged the agency is not certain of its information on firms' employee numbers. When inspectors show up at facilities and learn firms are not yet mandated to comply with supplement GMPs, rather than leave without inspecting a site they will conduct an inspection under food GMP guidelines, Williams said.

Even though raw ingredient suppliers are not subject to supplement GMPs, he strongly encouraged firms to get vendors on board with the requirements. For example, if a supplier declines to provide information on material testing because an assay is "proprietary," Williams recommended finding another supplier.

Additionally, Williams said an interim final rule to allow certain firms to petition for an exemption from 100 percent identity testing of dietary ingredients is not likely to become a final rule.

"If I were a betting man, I would not bet highly on this ever becoming a final rule," he said, citing roundly unsupportive comments the agency has received from industry.

Supplement industry experts have said firms would likely petition for the exemption under such a rule, but that the criteria for FDA granting an exemption would rarely be met (² Also see "GMP Interim Final Rule Sets Bar High For 100% Testing Exemption – Experts" - Pink Sheet, 23 July, 2007., p. 3).

- Dan Schiff (d.schiff@elsevier.com)

Looming GMPs Could Doom Some Firms Unless Industry, FDA Lend Support

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