The Government Accountability Office (GAO) claims functional foods will rake in close to $50 billion in sales by 2010-proof that functional foods have finally reached a point of critical mass, making the market and its products ripe for debate. Right now this class of foods has a good chance of reaching the $50 billion mark, provided the regulations currently governing them remain untouched, or refined to encourage more research and innovation, as suggested by many groups that testified at FDA's December 5th hearing, such as the Institute of Food Technologists (IFT), Chicago, IL, and the American Herbal Products Association (AHPA), Silver Spring, MD. But if groups like the Center for Science in the Public Interest (CSPI), Washington, D.C., have their way, the regulations will become more restrictive in terms of the ingredients allowed in such products and their subsequent marketing, health claims included.

In a statement issued the same day of the hearing, the Natural Products Association, Washington, D.C., said the high interest in these products of late is related to their rapid proliferation in the mass market. "The growth of functional foods in the mass market, coupled with increased availability of health information, often makes for unbalanced and provocative media attention, causing undue concern regarding the appropriate regulatory checks and balances," it said. And therein lies the issue that has groups facing off against each other.

There are two sides to the functional foods debate. The industry-supported position is that functional foods could potentially have enormous public health benefits if the regulations are left alone or enhanced, while the other side views functional foods in the context of energy drinks, being no more beneficial than concoctions containing water, sugar and caffeine. Adding to the latter, CSPI's legal affairs director, Bruce Silverglade, believes "the food industry is pressuring the Bush Administration to extend already weak standards for dietary supplement ingredients and label claims to these 'newfangled' products. That approach would make functional foods, a potentially useful idea, about as dependable as 19th century snake oil." He went on to describe functional foods in the present market environment as "dysfunctional" foods.

In his testimony, Mr. Silverglade also highlighted new products like Enviga-a recent joint venture launch from Nestlé and Coca-Cola-as violating current laws. In fact, the day before its testimony on functional foods, CSPI released a statement warning that it would sue the makers of Enviga if they continued to market the drink with "fraudulent calorie-burning and weight loss claims." "They should have called this drink 'Fleece,' since that's what they're trying to do to consumers," CSPI said. "Plain old tap water has zero calories, five calories fewer than Enviga, but unlike Enviga, tap water doesn't cost 15 bucks a gallon."

The Grocery Manufacturers Association (GMA), Washington, D.C., which recently joined forces with the Food Products Association (FPA), Washington, D.C., issued a joint statement following the hearing, reiterating its position that there exists adequate regulation for functional foods. "We believe there is no value in having a separate and distinct regulatory approach for some foods versus others," said senior vice president and CSO Pat Verduin. "Furthermore, currently statutory and regulatory provisions require that ingredients used in the formulation of any food-including those that bear health or structure/function claims-must be approved food additives, or generally recognized as safe (GRAS), for intended use. This would include any novel or unique ingredients being incorporated into foods for functional benefits."

AHPA also maintains that FDA has full authority to ensure that foods and food ingredients are safe. Anthony Young, Esq., AHPA's general counsel, spoke on behalf of the organization at the public hearing. He noted the re­quirements for all ingredients added to foods to be GRAS include a notification process for novel ingredients, and provide an established framework that applies to functional foods. He also believes the recent controversy swirling around functional foods seems to have been triggered by the massive proliferation of energy drinks, many of which contain varying amounts of caffeine. "Much of the concern about functional foods seems to focus on beverages that contain caffeine…AHPA recommends that FDA use its authority to initiate a new rule that would require the amount of caffeine added to food be stated on the product label," Mr. Young said.

Let the Science do the Talking

Barbara Petersen, PhD, MPH, principal scientist and practice director, Exponent, Washington, D.C., and a member of the IFT Expert Panel that issued a report on functional foods in 2005, titled "Functional Foods: Opportunities and Challenges," was one of two (CSPI being the other) that gave longer testimony at the FDA hearing; the 12 others offering testimony were given about five minutes to state their case.

From her point of view, the science should be able to dictate what manufacturers can say about their health products. For that reason, she too believes most of the current regulations in place are more than adequate to regulate functional foods. What she and some others suggested, however, was devising a system to address the efficacy part of the equation. "What we want FDA to understand is that the safety evaluation for functional foods is already working really well in the context of GRAS status and food additive provisions. What we would like to see developed is a parallel track that deals with efficacy-generally recognized as efficacious (GRAE) status, for example. That parallel track would do the same thing that a GRAS or food additive petition does for safety, but relates instead to whether or not a product works according to its intended use," she explained. "There is no reason a manufacturer couldn't go through this process from an efficacy standpoint, using an independent expert(s), and then going through a notification process so FDA still has the opportunity to review and confirm that they agree or disagree with the findings."

Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT, and also a member of the IFT panel that put together the 2005 functional foods report, said the industry is quite interested in the GRAE process because they're looking for more incentives to conduct the necessary research to make claims. But there are some issues with the proposed process. "The problem lies in granting exclusivity for a specific claim to a specific company for an individual product in a market driven by using public information, or the illicit 'borrowing' of private information. The time is more than overdue to give companies good reason to invest the resources to come up with useful as well as profitable claims. This is an attractive idea, but with many technical challenges to make it work efficiently in a competitive market."

Further, Mr. Israelsen pointed out, there will be some difficulty in establishing a GRAE panel because FDA doesn't want to give up being the "arbiter of effectiveness." "FDA is very reluctant to see the establishment of efficacy evolve into a private process," he said.

Dr. Petersen also brought up "nutritive value," which she said needs to be more clearly defined on a general level rather than on a case-by-case basis. According to IFT's 2005 report, the definition of nutritive value should be replaced with a more inclusive definition: "that benefits for functional foods should be based on nutritive value or through the provision of a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for a plausible mechanism."

Mr. Israelsen explained nutritive value in more detail. "Food is something that offers taste, aroma or nutritive value. The trouble lies in determining what is meant by nutritive value," he said. "A functional food ingredient is typically a substance that imparts a health benefit beyond basic nutrition, but that is not a nutrient. Most of the time functional foods contain ingredients that are not considered nutrients because they don't have an RDI (recommended daily intake) or DRV (daily reference value)-and they don't reside inside the Nutrition Facts panel."

As a result, many companies are challenged when trying to figure out how to describe the benefit of their functional food ingredient. "Do you establish an RDI of DRV for a functional food ingredient that is not an essential nutrient?" Mr. Israelsen said. "RDIs and DRVs determine nutritional necessity and value. That in turn decides what products are covered by health insurance or food stamps, or become part of school lunch programs."

He continued, "From my perspective, nutritive value is not only about pure nutrients anymore; it also includes substances like omega 3s, polyphenols and probiotics."

Dan Murray, vice president of sales for food and beverage, InterHealth Nutraceuticals, Benicia, CA, believes the main focus at this point should be safety rather than efficacy. He says there are simply too many conflicting views on how to determine what evidence is needed in order to establish efficacy. "I don't know if IFT or FDA are in a position to determine what is efficacious across a broad population," he said. "If 15 experts in Japan and Europe come to consensus on the efficacy of a product, shouldn't that be considered significant scientific agreement?"

Another issue posed by the Natural Products Association is the use of structure/function claims on foods labeled as dietary supplements. The association believes these claims should apply not only to dietary supplements, but also functional foods. "If a manufacturer follows the food additive laws (where appropriate) why should they be limited in providing the consumer information on the benefits outside of nutritive value that the 'functional food' may offer?" the organization said.

InterHealth's Mr. Murray found the conversation surrounding the inclusion of dietary supplement ingredients in food and beverage products particularly interesting. "If a company chooses to put a dietary supplement ingredient in a beverage and label it as a supplement they should be allowed to do that, provided it has met all the appropriate criteria," he said. "Consumers should be trusted to read the labels and figure out any differences that exist. We can't legislate common sense."

He went on to say that consumers sometimes want to take supplements in forms other than pills, and functional foods and beverages represent the opportunity to do that. "You can't shut down a whole area of application just because a product doesn't fit perfectly into a regulatory category," he commented.

What Next?

For the future, Mr. Israelsen believes there will be some interesting coalition building. "You will probably see the conventional food and dietary supplement industries recognizing that there are large areas of common ground, all driven by common interest in key ingredients," he said.

Mr. Murray predicts a lot more people will start focusing on dosage. "It is a real challenge to decide how much of an ingredient to put into a supplement versus a functional food. As an ingredient supplier with data to show health benefits at certain levels, we would like to see that replicated as much as possible," he explained. "But we also recognize that a very reasonable person might take one serving per day whereas another very reasonable person might take three per day. Yogurt drinks or nutrition bars are good examples of this."

The Natural Products Association also brought up the issue of GMPs. While it was not addressed in the hearing itself, the organization said it warrants attention. "While GMPs and extensive guidance are available on the manufacturing practices of foods, at the time this document was submitted the final rule regarding the GMP of dietary supplements had not yet been released from the Office of Management and Budget (OMB)," the association said. "Once the dietary supplement GMP rule does become final, where do products containing 'supplement' ingredients in 'conventional foods' reside with respect to manufacturing practices? Will the agency offer additional compliance guidance and regulation as they do with infant formula and medical foods? We believe GMPs are part of the answer as well, offering appropriate consumer protection."NW