FDA Focus On Food Safety Regulations May Delay OTC And Supplement Rules

FDA will try to eke out rules on OTC drug reviews and supplement labels in 2012 with its hands full implementing the food safety act. In the latest regulatory agenda, FDA priorities include an NPRM on foreign supplier verification and regulations to accredit third-party auditors to inspect firms across the agency’s oversight.

FDA will have its hands full in 2012 implementing requirements in the Food Safety Modernization Act, which could push back the publication of other pending and much-anticipated regulations.

But the agency still will try to eke out proposed and final rules related to several OTC drugs as part of its ongoing monographs review, and could propose several label changes that will impact the supplement industry, according to the Department of Health and Human Services’ Jan. 20 semi-annual regulatory agenda.

Deadlines in unified agendas that HHS and other federal departments publish are not binding and FDA often pushes back the dates as new or more pressing priorities arise.

The agency is near finishing several rules in the agenda, but “food safety deadlines tend to take priority,” said Duffy MacKay, the Council for Responsible Nutrition’s VP for scientific and regulatory affairs.

FSMA provisions “have absolute deadlines written into the law that [FDA is] trying to keep. So, some of these other rules that are more flexible, that don’t have deadlines, will be knocked to the bottom of the pile,” MacKay explained.

One of the most pressing FSMA mandates the agency is prioritizing is clarifying, in a notice of proposed rulemaking, what importers must do to prove imported food products meet U.S. standards and are not adulterated or misbranded.

MacKay warned this provision “is going to get really, really complicated because there are a lot of different players in importation.”

The Foreign Supplier Verification Program, effective Jan. 4, 2013, will be risk-based and could include monitoring records for shipments, periodically testing and sampling shipments and other elements, FDA says in the agenda.

Many supplement firms likely already meet this “monumental task” because the 2007 good manufacturing practices final rule mandates this level of import verification, MacKay noted, adding this is significant for food firms, including those marketing functional foods.

Even though supplement GMPs require this level of verification, many firms still struggle to meet the requirement, according to FDA officials (Also see "Guaifenesin warning letter" - Pink Sheet, 29 Mar, 2004.).

FDA acknowledges “the costs will be significant” for implementing Foreign Supplier Verification regulations, but it adds, “we expect that the adoption of FSVPs by food importers will lead to significant reduction to the threat to public health posed by unsafe imported food.” FDA missed its goal of publishing the NPRM in January.

FSMA also requires FDA to inspect 1,200 foreign facilities in 2012 and even more in the following years to ensure all high-risk facilities are inspected by Jan. 4, 2016 (Also see "Supplement Ingredient Suppliers Should Prepare For Food HACCP Regs" - Pink Sheet, 9 May, 2011.). Given that “FDA may not have adequate resources to inspect” all those facilities in a particular year, the agency is prioritizing proposing regulations to accredit third-party auditors to inspect food safety and some foreign firms, according to the agenda (Also see "Former Food Safety Chief Doubts FDA Can Meet Foreign Inspection Mandate" - Pink Sheet, 12 Dec, 2011.).

An NPRM on accrediting third-party auditors slated for February also would set standards for inspectors.

FDA also expects to finalize by August amended administrative detention regulations that reflect authorization established in FSMA to detain food that agency officials have “reason to believe” is adulterated or misbranded, according to the agenda. This controversial amendment expands FDA’s previous authority to detain imports if it had “credible evidence” of risk of a serious adverse health event.

OTC Drug Review A Priority

The agency also hopes to publish proposed rules related to the ongoing OTC drug review of acetaminophen, topical antimicrobial drug products, pediatric dosing of cough/cold products and sunscreen, according to the notice.

Industry could know by June if FDA intends to lower the single and daily doses stated on acetaminophen product labels if the agency meets its goal to publish an NPRM about the painkiller’s safety.

The agency does not indicate in the agenda whether it will follow an advisory committee’s July 2009 recommendation to lower the single adult doses of acetaminophen to 650 mg from 1,000 mg. Such a move would impact the industry significantly because many firms would need to change the tablet size and packaging of the painkiller (Also see "Lower Acetaminophen Doses Recommended Despite Cost Impact, Lack Of Data" - Pink Sheet, 6 Jul, 2009.). The NPRM also could address package sizes of acetaminophen products and whether to remove acetaminophen from combination products, which the panel did not recommend.

FDA says by the end of the year it will address in a separate NPRM whether pediatric dosing of acetaminophen should be based on weight and age. An advisory committee in May 2011 recommended the agency require weight-based dosing on pediatric acetaminophen products and add dosing information for children younger than 2 years (Also see "Pediatric Acetaminophen Panel Debates Execution Of Dosing Changes" - Pink Sheet, 23 May, 2011.).

FDA also finally is poised to address the safety and efficacy of pediatric cough and cold products, which the agency began considering more than four years ago. A children’s cold medicine NPRM slated for publication in July likely will address a 2007 advisory committee’s unanimous recommendation that children younger than 2 years should not use cough/cold medicines and a closely split vote on whether 2- to 5-year-olds should use the drugs (Also see "FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6" - Pink Sheet, 22 Oct, 2007.). The NPRM also could address advisory committee recommendations to standardize OTC pediatric cough/cold labels and dosing devices (Also see "Standardize Wording, Dosing Devices of Pediatric Cold Products – NDAC" - Pink Sheet, 29 Oct, 2007.).

The Consumer Healthcare Products Association in 2007 launched an education campaign to rethink children’s cold product risks and has studied the pharmacokinetics of many cough/cold ingredients in children.

On the personal care side, FDA will continue to chip away at the sunscreen products review. It projects issuing an advanced NPRM on the safety of sunscreen active ingredients by June.

FDA pushes back its estimate for when it will address the potential addition of ingredients to the sunscreen monograph through time and extent applications. The agency now projects publishing an NPRM by August 2012 instead of the previously estimated April (Also see "Guidance Underscores FDA Practice Of Letting TEAs Steep" - Pink Sheet, 3 Oct, 2011.).

FDA Will Rule On Daily Reference Values

FDA’s plan to revise the Nutrition and Supplement Facts labels is a “big deal,” and has piqued CRN’s interest, MacKay said.

He said the NPRM that FDA aims to publish by December will address whether to base daily reference values on estimated average requirements – the level at which 50% of the population’s needs are met – or on the recommended dietary allowance – the current method that reflects the level at which 97.5% of the population’s needs are met.

If FDA switches to using estimated averages – which are lower than recommended allowances – as the DRV denominator, food products lower in nutrients will provide a higher percent of the daily intake value, MacKay said. “It is almost equivalent to moving the goal post closer” and could result in some people consuming insufficient amounts of nutrients, he said.

The switch also could lower ingredient and finished supplement sales. Consumers may buy fewer supplements because they will perceive their food as providing a greater percentage of what they need. Fortified food makers also would not need to add as many nutrients to products to claim they meet 100% of consumers’ daily needs (Also see "Base Daily Nutrient Values On RDAs, Not Weighted Estimates – CHPA, CRN" - Pink Sheet, 19 May, 2008.).

FDA also says the NPRM will base the DRVs on the “latest scientific evidence” from consensus reports, such as the Institute of Medicine, which in December 2010 set the daily value of vitamin D well below the amounts some nutrition experts suggest (Also see "IoM Sets Vitamin D Intake Levels Below Experts' Expectations" - Pink Sheet, 6 Dec, 2010.). The proposed rule will include DRV and daily intake values for foods for children younger than 4 years and pregnant and lactating women, and change the mandatory declaration of specific nutrients, FDA says.