GMPs, Food Safety, Industry Guidances Among CFSAN’s 2002 Top Priorities

Industry guidances on dietary supplement regulations and labeling issues are slated to be released by FDA's Center for Food Safety & Applied Nutrition over the next two years.

At the top of the center's "efficiency/responsiveness" goals for supplements in FY 2002 are the completion of a "Regulatory Guidebook" and an "update for common or usual botanical names used in dietary supplement labeling."

Both items are designated by CFSAN as "A" list priorities for the year, according to the center's program priorities document, released Jan. 28.

Issuance of a "Dietary Supplement Labeling Guide" carries a lower-priority "B" status this year. The guide initially was an "A" priority last year, but was downgraded mid-year in favor of more pressing matters such as food allergens and BSE (¹ (Also see "CFSAN" - Pink Sheet, 16 Jul, 2001.), In Brief).

The document highlights CFSAN's goals for the year, placing them into three categories. The highest priorities are assigned "A" ratings, 90% of which the center hopes to accomplish by Sept. 30, 2003. "B*" priorities denote the top of the "B" list, which are mostly two-year projects that likely will be promoted to the "A" list in the next fiscal year.

Reporting to Congress on the amount CFSAN spent in FY 2000 "to assess the safety of dietary supplements," as well as the projected "dollar cost to implement the Dietary Supplement Strategic Plan," remain "A" priorities, as they were in FY 2001.

CFSAN also plans to fold dietary supplements into its ongoing compliance programs for food pesticides and contaminants in 2002. Under the sub-strategy of "enforcement/compliance," inclusion of supplements within such programs is regarded as an "A" priority.

The overarching issue of food safety will remain the center's top concern, CFSAN Director Joseph Levitt stressed at a same-day press briefing.

CFSAN lists five "A" items under the general topic of food safety, including plans to "hire, train and deploy additional resources as provided by Congress, with particular attention to strengthening surveillance of imported foods." Levitt said the center has "30 positions and about $7 mil...that will be devoted to supporting those field activities."

Also high on the list is the creation and implementation of strategies to prepare for terrorist events related to food, to be outlined in a "Food Security Action Plan."

"Continuing to strengthen our work with our sister agencies, both in the federal level and at the state and local level...as well as with strengthened work in the law enforcement and intelligence side," also is an "A" priority, Levitt said.

In FY 2001, a coordinated effort between CFSAN and the Department of Agriculture resulted in bans of imported "food products, dietary supplements and cosmetics that contain bovine materials from BSE-identified countries," Levitt noted, referring to the center's 2001 report card, also issued Jan. 28.

In spite of the increased attention, all three Transmissible Spongiform Encephalopathies goals for FY 2002 hold "B*" status. CFSAN intends to continue working with USDA to create a policy "prohibiting use of any part of an elk or deer exposed to Chronic Wasting Disease from CFSAN-regulated products," a reg that would cover dietary supplements.

A similar goal is to establish a regulation to "minimize human exposure to BSE" by prohibiting the use of bovine brains and spinal cords from animals older than two years in CFSAN-regulated products.

Food allergens, which were promoted to "A" status midway through last year, again hold five of CFSAN's 92 "A" priority spots. "We're trying to schedule 1,000 inspections looking at food allergens and whether allergens are properly...kept out of products or labeled on products," Levitt noted.

Other food safety initiatives include: creating strategies to protect against cross-contamination and enhancing enforcement; training investigators about allergens; and educating consumers and industry about allergens in foods.

The long-awaited proposed rule on good manufacturing practices for supplements remains an "A" priority.

Addressing the delay, Levitt said the pending rule is "a significant regulation of importance" and therefore "is worth a new administration having time to go through it, understand it, be comfortable with it and be sure it is consistent with the administration's goals."

Levitt declined to provide a timeframe for the reg's release, noting only it is "very much on the front burner."

CFSAN's adverse event reporting system also remains an "A" list priority, with plans to "develop standard operating procedures and pilot new test systems for the processing of adverse events."

Three "B*" priorities include publishing final rules on infant formula GMPs and quality factors, stanol/sterol esters health claims and trans fatty acid labeling, which held "A" status at the beginning of last year.

Levitt pointed to the Institute of Medicine/Food & Nutrition Board's ongoing review of macronutrients, noting the report "is likely to have a significant impact on what we should do with respect to trans fat."

"We're going to need some time to absorb that report and figure where to go from there, so...we decided to show it's important to us, but it is going to take more time before you see something published," he added. FNB is expected to issue the report this spring.

Development of a strategy for supplements containing ephedrine alkaloids is listed as a "B*" priority for 2002. The issue had been assigned "A" status at the start of FY 2001, but was shifted to "B*" mid-year.

The topic "continues to be a challenge," Levitt said. Citing the seizure of E'Ola's synthetic ephedrine hydrochloride in October 2001, the director noted the center is "trying to focus on where the most acute needs are" (² (Also see "E’Ola Ephedrine HCl Product Seized, FDA Complaint Alleges Item To Be Drug" - Pink Sheet, 5 Nov, 2001.), p. 5).

In a Jan. 31 letter to HHS, Public Citizen urges FDA to take action against nine companies purportedly selling supplements containing synthetic ephedrine hydrochloride (see ³ (Also see "Synthetic Ephedrine Found In 10 Marketed Supplements – Public Citizen" - Pink Sheet, 4 Feb, 2002.)).

Levitt also pointed to the ongoing National Institutes of Health review of ephedra literature, due out mid-year. He acknowledged the review probably will not provide a definitive solution, but rather is "likely to suggest the need for additional study."

"I think there is always new information coming out, and I think we all have to be prepared to evaluate or respond to anything new," he said. "We need to be open to whatever that new information shows."