Are EFSA Protocols OK for USA?

Most of us know that the European Food Safety Authority (EFSA) requires a company's supplements health claims to be authorized via application. Claims fall under three categories:

EFSA 13.1—General function claims referring "to the role of a nutrient or substance in growth, development and body functions; psychological and behavioral functions; slimming and weight control, satiety or reduction of available energy from the diet."

EFSA 13.5—"Based on newly developed scientific evidence and/or for which protection of proprietary data is requested. For these health claims authorization is required on a case-by-case basis, following the submission of a scientific dossier to EFSA for assessment."

EFSA 14.1—These claims "refer to the reduction of disease risk or to children's development or health."

Would such a protocol work in the U.S.? I asked around.

Rich Cleland, assistant director, division of advertising practices, Federal Trade Commission: "We wouldn't have the legal authority to impose that kind of regulatory regime, and for us that would take some significant legislation. To be honest, I don’t see it happening in the near future."

Daniel Fabricant, director of the dietary supplement program division, Food and Drug Administration, dismissed the idea: "We take the tools that are available and build our respective houses with them."

Eric Anderson, vice president, sales and marketing, Aker BioMarine Antarctic U.S.: "I'm on board with DSHEA, I'm not for companies cheating and not getting away without any retribution. Governments are here to protect consumers. When [companies] are fraudulent and taking advantage of consumers that's the problem."

As for the differences between FDA and EFSA, Mary Van Elswyk, Ph.D., an industry consultant and registered dietitian, says that for structure function claims, EFSA requires the research related to a claim be presented for review and approval. FDA requires supplement companies with structure function claims to have that information on file and to notify FDA of their intended use of that claim.

Van Elswyk, who has written EFSA claims applications, adds that EFSA has no option to award qualified health claims. Under Article 14, she says, a list of approved and rejected health claims is available for companies to consult. Rejected health claims aren't easily available in the U.S. 

EFSA procedures are in the early stages, she notes. "The process is pretty well defined, now they're using it and working out the details," Van Elswyk says. "The regulation is specific and well defined, but implementation is still sort of evolving."

What are the "details"? According to Van Elswyk, there's no protocol for updating an approved Article 13.5 claim when new science comes out. Recently, claims deemed invalid due to insufficient data have the opportunity to be reevaluated. And then there's backlog: Around 44,000 Article 13 claims have been whittled down to roughly 4,000 to review before 2012, which is two years past the initial deadline.

Maybe in the next five to 10 years, the benefits of EFSA's system will be crystal clear, allowing for federal agencies to give it some thought. In the meantime, industry companies should follow what's happening across the pond.

"EFSA has proactively established a review process which is science-based and dependent upon world experts," says Bill Turney, senior manager, regulatory affairs, at DSM Nutritional Products. "The outcome of deliberations by academic scientists via this government-sanctioned process cannot be ignored. Moreover, the food industry operates in a global market [that] benefits from harmonization of regulations and claims. Because of this globalization, the U.S. will face increasing pressure to allow claims approved by EFSA in European markets."