AHPA Asks FDA to Cite Regulations on Form 483s

WASHINGTONShould FDA inspectors who cite dietary supplement firms for violating cGMPs (current Good Manufacturing Practices) reference the specific regulation that correlates to each infraction?

The American Herbal Products Association (AHPA) thinks so. On Oct. 17, it petitioned FDA to implement such a practice when issuing what's known as a Form 483 to food and dietary supplement facilities.

Inspectors who have inspected a dietary supplement facility for cGMPs cite infractions or "observations" on a Form 483. But FDA's Inspections Operations Manual currently forbids inspectors from quoting regulations when listing observations, according to AHPA.

Failing to disclose the relevant regulations "forces industry members to play an unnecessary regulatory guessing game," AHPA stated in the petition. "This slows resolution of compliance issues and undermines Agency transparency. That this policy does not appear to further any Agency or public health interest also supports its abandonment."

Arthur Whitmore, an FDA spokesman, declined to comment on the petition other than say the agency will review it. He also did not immediately comment on the rationale for the manual's policy.

Anthony Young, a Washington, D.C.-based food and supplement attorney who serves as AHPA's general counsel and is a partner with Kleinfeld, Kaplan & Becker, LLP, said it can be difficult for businesses to determine what regulations FDA is referencing when it cites them for cGMP observations.

A citation of the relevant regulations by FDA inspectors would help the industry, he said.

"Once you know the regulation, you can read the requirements," Young said in a phone interview. "You can better understand how the little descriptions they give demonstrate you weren't in compliance with the requirement."

Young said FDA may have been concerned in the past that inspectors would cite the wrong regulations. But he expressed the belief that technological advances have eliminated such concerns.

"We understand they take the first words for every observation out of a computer program and that computer program cross links to the regulation," he explained. "If the issue of not citing the right provision was the issue in the past, it shouldn't be the issue now."

Justin Prochnow, a Colorado-based food and supplement lawyer with Greenberg Traurig, LLP, said most supplement firms can eventually decipher the infractions that FDA inspectors are alluding to on a Form 483. But he acknowledged it may take the firms time and consultation with an attorney such as himself to figure it out.

"It's a question of time involved and clarity. Why not just tell companies so that it's out there instead of having them go through and find it themselves?", Prochnow said. "If the FDA is citing these observations, the inspectors certainly have an idea at that point what specific regulations are being violated."