High hopes, limited regulation a dangerous formula for ‘functional foods’

By Lisa Scott
Independent Journalist

Journalists covering nutritional supplements and so-called functional foods should compare the marketing messages of manufacturers to the science behind those claims, said panelists at a Health Journalism 2010 session on the topic.

Consumers spend billions of dollars annually on supplements and functional foods, said Marilyn Marchione, medical writer for the Associated Press. Although such products face lower regulation than pharmaceuticals, many consumers seek "drug-level effects," she said.

High consumer hopes and limited regulation are a volatile mix. The result can be misleading marketing and even real dangers to consumers.

According to panelists on "Assessing claims of functional foods and nutritional supplements:"

• "Natural" – a term for which no legal standards exist – does not mean products are harmless. Natural products still can contain biologically active ingredients, possibly at unsafe levels, and possibly that might interact dangerously with drugs and foods.
• Some products have been found to contain ingredients differing from the labels or to contain contaminates. The Food and Drug Administration has required the largest supplement makers to meet good manufacturing practices only since July 2008 while the smallest manufacturers have until June 2010. Even then, FDA oversight is limited by its budget and priorities.
• Scientific support for products' claims can be limited. The FDA has not defined how much evidence is needed to make a common type of claim known as a "structure and function" claim.

A broad and growing variety of products are marketed with health-related claims. To underscore the point, Marchione began her presentation by pouring packets of sugar into a glass of water. "I've just made an energy drink," she said. "We need to think hard about how we report" on these products.

Bruce Silverglade, of the Center for Science in the Public Interest, scoffed at the term "functional foods."

"All foods are functional."

The evidence manufacturers need to support health-related claims depends on the type of claim. "Health claims" make specific statements about a product's benefit, such as "reduces the risk of prostate cancer." Those claims require FDA approval and must be backed by significant scientific agreement.

Structure and function claims state that products support normal healthy structure and function, i.e. "helps maintain normal functioning of the prostrate gland." Such claims don't require FDA pre-market approval, although the FDA may act to end claims it deems untruthful or misleading. But the FDA hasn't defined that standard clearly and has taken few actions to block manufacturers, said Silverglade, legal director at the center.

The problem is, consumers often take away the same message from structure and function claims as from the more stringently regulated health claims, he said. In chapter six of a 2009 report, "Food Labeling Chaos," the center outlined steps it thinks the FDA should take to increase oversight.

The third and final panelist, Neil Levin, programs chair of the American Nutrition Association and nutrition education manager for NOW foods, which makes supplements, agreed that manufacturers' claims should be tested against the evidence and be regulated. However, in his opinion, the current laws would be adequate, with some "fleshing out" of the definitions. The problem is not the law, but FDA resources and priorities, he said.

Levin also urged journalists to be aware of a bias toward pharmaceuticals that might exist among some sources.

Marchione warned against allowing manufacturers to redefine the issue into one about cultural sensitivity and open-mindedness instead of effectiveness; for example, by stating that a key ingredient has been used in Eastern medicine for years.

Journalists owe it to readers not to write "cop-out stories" in what Marchione called "alternative reporting mode:" "He says it works. She doesn't. You, dear reader, decide."

"Keep your values. Keep your standards. Don't be reframed," she said.

Among her tips for better reporting:

• Give details on the herb or substance: dose, formulation, manufacturer and cost.
• Clearly state what science has shown and do not overstate the conclusiveness of test-tube or animal studies, limited-size studies, or studies that lack a control group.
• Don't rely on testimonials and anecdotes, the weakest form of evidence.
• Accurately describe the benefit being claimed (do not allow someone to make a disease claim) and point out risks, known and unknown, and side effects.
• Ask and disclose whether the substance is unsafe for any potential user group.
• Disclose a study's funding and the financial interests of supporters. Likewise, find out whether critics have conflicts and biases.
• Include comments from qualified and unbiased experts as opposed to marketers, other sources in the same industry, lobbyists or trade groups or other vested interests.