Critics believe the FDA ruling on exemptions counters new GMPs

United States Despite the US Food and Drug Administration (FDA) issuing an interim rule that would exempt certain ingredients from identity testing, debate continues to rage about the merit of the rule.

Critics are concerned identity exemptions could compromise the very product quality the recently enacted and long-awaited GMPs set out to address. Others say exemptions are necessary in certain situations (for example, where smaller companies are unable to afford authorised identity testing) just as there are exemptions that allow nonorganic ingredients to be used in organic foods to ensure supply continuity (such as the limited or nonavailability of organic versions of certain additives).

Andrew Shao, PhD, vice president of scientific and regulatory affairs at the Washington, DC-based Council for Responsible Nutrition (CRN) told Functional Ingredients he would be very surprised if the interim rule permitting exemptions stood in its current form.

"The FDA is unlikely to grant exemptions from 100 per cent identity testing for one main reason: manufacturers won't file petitions — most manufacturers are opposed to reduced identity testing, and even if it were an option, would never consider it," he said, noting potential liability weighed too heavily with most supplements manufacturers.

"For larger companies, the cost of putting together a petition far outweighs the cost savings of reduced testing, again leading to fewer petitions. While smaller manufacturers might experience a slight cost savings from an exemption, the amount of data the FDA would need to grant such an exemption exceeds smaller companies' capacity to generate such data.? It's ironic — the companies that might possibly experience a cost savings can't afford to petition the agency in the first place."

The Natural Products Association has taken a similar position, stating in a letter to the FDA: "Submitting a petition to request an exemption from 100 per cent identity testing of a dietary ingredient is not something that should be taken lightly, nor should such exemption be granted without exhaustive demonstration of both the supplier's or vendor's and manufacturer's quality system."

Given the general lack of enthusiasm for the veracity and worth of Certificates of Analysis, upon which the GMP regulations are pinning their quality-assurance hats, the case for 100 per cent identity testing becomes more compelling. As the executive director of the Utah-based United Natural Products Alliance, Loren Israelsen, noted recently: "Everything will revolve around confirming the identity of material." Shao noted confusion remains about when a dietary ingredient becomes a food supplement, and thus when it falls under food law and when it falls under supplements law.