EU Health Claims Review Limits Language, Raises Costs For Firms

Nutritional supplement firms in Europe face escalating costs for differentiating their product claims under a master list of general health claims the European Food Safety Authority is compiling.

Meanwhile, industry stakeholders are scrambling to determine what exactly EFSA looks for in accepting a claim and how firms can navigate the process.

Under a regulation on nutrition and health claims adopted by the European Commission in 2006 and expected to take effect starting in 2012, marketers will have the option of using limited "general function" health claims from a master list, or they will have to generate and submit data through a separate process in support of proprietary claims.

In addition to clinical costs, companies are facing a more rigorous regime in which many common claims will no longer pass muster.

EFSA essentially nixed claims for disease-related benefits, meaning clinical data must be for reduced risk of certain conditions in healthy individuals, explained Joerg Gruenwald, president of German consulting firm Analyze & Realize.

"So we end up in a system which is really much tougher than even the regulations for drugs, where definitely a drug is there to treat people or to prevent disease," Gruenwald said.

"It sets the hurdle extremely high to prove anything."

Gruenwald's Berlin-based firm, which provides contract research for food, supplement and botanical products, now is redesigning studies using subjects who may be susceptible to certain conditions - high blood pressure, for example - but otherwise are healthy.

Even substances with solid data in people with existing conditions - such as cranberry products in women with urinary tract infections - must revise their claims.

"Most of the companies are having a problem because all the old data which they have historically [generated] cannot be used, are not good enough to prove an EFSA claim," said Gruenwald.

He added the new approach is feasible but challenging and costly.

The U.K.'s Health Food Manufacturers' Association is concerned EFSA is using "an inappropriate, pharmaceutical-based approach" in evaluating nutrient claims (¹ (Also see "European Health Claim Review May Apply Rx Criteria To Foods - U.K. Group" - Pink Sheet, 5 Oct, 2009.)).

One Batch At A Time

EFSA is working through a list of 4,185 general health claims that firms authored and submitted through EU member states under article 13.1 of the EC regulation. The authority's Panel on Dietetic Products, Nutrition and Allergies issued opinions on 523 claims in October 2009, with the next batch due in February and more slated throughout this year and into 2011.

The phased release of the claim opinions is one source of ire for the European Federation of Health Product Manufacturers.

"It is distorting the market because you have companies whose claims are evaluated which can make profit on that, while the rest are still pending evaluation," said Lorene Courrege, the federation's director of regulatory affairs. "We believe this is really not good for competition."

Courrege added firms marketing products with multiple claims for different ingredients may end up revising their labels multiple times as the opinions gradually come out. Although the opinions are not yet legally binding, many companies proactively are adjusting their claims.

Thus far, most claims have not fared well under EFSA scrutiny. Gruenwald said many in the industry were "a little bit shocked" that about 80 percent of claims were rejected in the first batch.

Winning The Claims Game

Vitamins and minerals and omega-3 fatty acids are "winners" of the evaluation process so far.

The scientific ² opinion EFSA issued on vitamin A, for example, concludes the substance has an established association with normal function of the immune system and maintenance of normal vision, though it rejects a cause-and-effect relationship between the vitamin and maintenance of normal bone, teeth and hair.

The authority's ³ opinion on omega-3s concludes a link exists between consumption of EPA and DHA and reduced blood pressure. Separate claims for maintenance of cholesterol levels did not pass muster with EFSA.

Omega-3 stakeholders view the EFSA claim evaluations "a little different from the rest of the nutraceutical industry, simply because we have a much larger body of science to stand on," according to Adam Ismail, executive director of the Global Organization for EPA and DHA Omega-3s.

Seeking Clarity On EFSA's Process

Others in the industry may have science to support their claims, but not necessarily what EFSA wants.

According to Courrege, EFSA failed in delineating its criteria for claims data going into the process and is now unwilling to engage in dialogue with industry. She said the evaluation of each rejected claim indicates nothing about what type of data would be needed to support approval.

Gruenwald concurred in part, noting the EC regulation described the evaluation methods, but "nobody expected [EFSA] to be so rigid."

Courrege said EFSA's refusal to accept emerging science to support claims does a disservice to the consumer. She noted data on folic acid's benefits for developing fetuses gradually gained acceptance over a period of years.

"You have a whole span of time where your evidence is growing stronger and stronger, and you can have time to develop all the trials that you want," she said. "But in the meantime, people can benefit from the product."

Unlike the EU's Traditional Herbal Medicinal Products directive, which seeks to register products with at least 30 years of recorded medicinal use, EFSA's claim evaluations do not accept traditional use data (⁴ (Also see "EU Herbal Medicinal Directive Could Spike Supplement Firms’ Costs" - Pink Sheet, 13 Apr, 2009.)).

Using tea as an example, Courrege called this omission "a bit of a shame, really, because I don't think anybody has ever questioned the use or consumers have been misled by indications that chamomile tea helps you sleep or relax."

EFSA disagreed with characterizations of the authority as closed and rigid.

"EFSA is an organization committed to openness, transparency and dialogue," a spokeswoman said in an e-mail, adding the authority has organized seminars, conferences and technical meetings to educate stakeholders on the claims evaluation process dating to 2006.

By hewing closely to its "sound science" requirement, EFSA "provides consumers with an independent guarantee of the truthfulness of claims" and helps guide industry innovation, the spokeswoman said.

Learning To Adapt

Nutritional product firms that choose not to pursue clinical data for proprietary claims will have the option of employing the general claims list, which allows for little product differentiation, Gruenwald noted.

Separately, the EC regulation permits firms to apply for "new function" claims under article 13.5 or disease risk reduction claims under article 14. Putting together dossiers for those claims requires investments of time and capital for clinical trials.

"I think there's a lot of creativity which will happen the next couple of years because everybody wants to have a proprietary claim and not only the list claim," Gruenwald said. "The legislation will not go away, we have to adapt to it."

Ismail agreed companies will be forced to evolve a greater emphasis on long-term studies and a reliance on regulatory affairs professionals to help navigate the EFSA process. In the U.S., he said FDA may shift away from the qualified health claim regime for supplements based on what happens in the EU.

FDA is "basically sending the message that they want a better, more rigorous and robust system in place," Ismail said. "I think they're definitely looking toward the EU to see how what they're doing works."

Industry stakeholders have defended the use of QHCs, though a 2008 Government Accountability Office report showed the claims confuse consumers and are opposed by medical, health and consumer groups (⁵ (Also see "Trade Groups Defend Qualified Health Claims Following Critical GAO Report" - Pink Sheet, 20 Oct, 2008.)).

- Dan Schiff ( ⁶ [email protected] )