fsma

Clearing the Clutter on FSMA, IND Applications and FTC

Dietary supplement industry regulation has been nonstop since FSMA was signed into law in January 2011; stay up to date with notable regulatory actions, including investigational new drug applications.

by Rend Al-Mondhiry

Dietary supplement industry regulation has rarely been dull since the FDA Food Safety Modernization Act (FSMA) was signed into law in January 2011. The most sweeping reform of U.S. food safety laws in 70 years, FSMA has generated lots of rulemaking lately, which can be challenging to keep up with. While many of us have been keenly focused on new dietary ingredient (NDI) notifications, there’s also regulatory activity in other areas of FSMA that warrants industry attention.

In addition, a new guidance for industry on investigational new drug (IND) applications may significantly affect how manufacturers substantiate products through scientific research.

Moving our attention from FDA to FTC, the January announcement of enforcement against fad weight-loss products drew ample media attention, but other matters are afoot that dietary supplement stakeholders need to know. Let’s break it down.

Beyond NDIs

The Council for Responsible Nutrition (CRN) has been closely monitoring FSMA rulemaking, submitting comments to FDA as appropriate. Most recently, FDA released proposed rules on sanitary transportation of human and animal food, and focused mitigation strategies to protect food against intentional adulteration. And just prior to these, FDA issued proposed rules for  accreditation of third-party auditors/certification bodies to conduct food safety audits and to Issue certifications, food supplier verification programs (FSVP) for importers of food for humans and animals, and current food manufacturing practice (cGMP) and hazard analysis and risk-based preventive controls (HARP-C) for human food.

A common thread of concern CRN noted in its comments is the need for appropriate differentiation between requirements for dietary supplement manufacturers versus ingredient suppliers, as well as removal of duplicative requirements. For example, regarding cGMPs and HARP-C requirements for human foods, CRN called for revisions that would eliminate redundant requirements for ingredient suppliers already complying with the strict rules for finished product manufacturers. Conversely, regarding FSVP requirements for firms importing dietary supplements for packaging and labeling, CRN called for consistency with the more robust proposed requirements for firms that import finished dietary supplements in order to adequately ensure safety. Firms must be mindful of their role in the supply chain and stay attentive to these proposed rules, ideally submitting comments and staying abreast of changes so they can be poised for compliance when the rules go into effect.

IND Guidance—a Game Changer?

FDA’s September 2013 final guidance, “Determining Whether Human Research Studies Can Be Conducted Without an IND," could significantly change how manufacturers substantiate products through scientific research by requiring an IND for any investigation merely associated with a disease, including those for common and widely used supplement ingredients. The IND process requires substantial resources and time investment, and is not designed for the study of food components. CRN emphasized this in comments on the draft guidance, but FDA proceeded as-is and even expanded the scope to include conventional foods and cosmetics. However, the agency re-opened the comment period on the guidance, following an outcry from a range of stakeholders. CRN is currently working with a coalition of food groups, along with nutrition science and academic organizations, to educate FDA about the implications of the guidance on nutrition research. Whatever the outcome, dietary supplement manufacturers and ingredient suppliers need to engage and prepare.

Over at FTC

On the advertising and claims front, FTC’s January press conference covered “Operation Failed Resolution," which took aim at egregiously misleading ads for weight-loss products with unsubstantiated claims that no responsible company would make. But, where does FTC opinion lie on substantiation of claims in a broader sense? That same day, FTC announced a consent decree worth noting wherein one Commissioner disagreed with the two-randomized-control-trial standard imposed by the Commission, and also, along with another Commissioner, questioned the apparent one-size-fits-all approach to substantiation. CRN submitted comments urging FTC to consider these Commissioners’ views. This topic will definitely be one to watch at FTC.

Want to delve deeper into these three regulatory hot topics? Join CRN and VIRGO on their next webinar, April 23. Visit www.naturalproductsinsider.com/webinars/2014/04/spring-regulatory-roundup.aspx for more information and to register.

Rend Al-Mondhiry, Esq., is regulatory counsel for the Council for Responsible Nutrition (CRN, crnusa.org), a trade association for the dietary supplement industry.

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