FDA allowing more claims for Foods, Crackdown on Supplement Claims

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FDA Cracks Down on Supplements, Eases Up on Food

By Todd Zwillich

 

WASHINGTON (Reuters Health) - Food manufacturers will for the first time be

allowed to tout the health benefits of their products even if there is no

scientific consensus as to the foods' benefit, under a plan announced

Wednesday by Bush administration officials.

 

Food and Drug Administration (FDA) officials also announced that they would

step up enforcement against several categories of dietary supplements where

misleading claims about health benefits are rampant.

 

The change in food labels allows manufacturers to make health claims as long

as the " weight of scientific evidence " supports the claim. Until now, such

claims were barred unless manufacturers could show that they were supported

by complete agreement among scientists. For example, oatmeal makers could

advertise the cholesterol-lowering properties of their product because there

was scientific consensus on the subject.

 

Administration officials said that the plan would promote public health by

attracting consumers to healthier foods when most of the science supports

their benefits.

 

" Our goal is to help consumers make sound decisions, " said Dr. Mark B.

McClellan, commissioner of the Food and Drug Administration.

 

McClellan said that the program would also spur competition among

manufacturers to produce more nutritious products.

 

Food manufacturers praised the move, saying that it would give shoppers

better information about which foods are best for their health. But the plan

drew harsh criticism from one consumer group, which argued that it would

only serve to encourage food companies to produce junk science in support of

the claims.

 

Under the plan, food manufacturers will submit a proposed health claim and

scientific data supporting it to FDA for a food ingredient such as omega-3

fatty acids. The compound, found in oily deep-sea fish like salmon, has been

shown in some studies to reduce the risk of heart disease.

 

FDA regulators will review the science supporting the claim and will approve

its use on product labeling if the " weight of the scientific evidence "

supports it, according to FDA documents.

 

McClellan said that the lower scientific burden would allow consumers to

benefit from healthier foods even when " it's not a completely settled

scientific issue. "

 

FDA has yet to finalize the process it will use to review the claims, or

exactly how it will define the amount of scientific evidence needed to make

a claim legal, officials said. The agency has set up a task force to

establish a review process and recommend final regulation that will govern

the process, they said.

 

McClellan said that most health claims would be " qualified, " meaning that

statement connecting the product's use to health benefits would be qualified

with a disclaimer alerting consumers that evidence is strong but not

conclusive.

 

" It's scientific evidence that determines whether or not we're going to

allow these claims, " McClellan said.

 

Rhona S. Applebaum, vice president of the National Food Processors

Association, an industry group, said that the new program frees up

manufacturers to alert consumers to the health benefits of many foods for

which at least some scientific debate is ongoing.

 

She cited studies supporting the role of high-fiber foods in reducing the

risk of colon cancer, and a growing body of scientific research showing that

a diet rich in fresh fruits and vegetables lowers cancer risk.

 

" To wait until there is essentially a firm conclusion...science rarely comes

to a firm conclusion on anything. It can take decades, " she said.

 

But Larry Sasich, a research analyst with the Public Citizen health research

group, attacked the program, saying it would allow companies to plant

low-quality studies in research journals and then submit them as scientific

proof of a food's health benefits.

 

" What is going to be fostered is spurious and unreliable studies, " Sasich

said. " No matter how bad the science is, if the guys that wrote it are

persistent enough, they're going to get it published somewhere in the

medical literature. "

 

Officials also announced a move to crack down on unsubstantiated health

claims made by dietary supplements makers. Regulators at both FDA and the

Federal Trade Commission have become increasingly concerned about

supplements makers who claim health benefits on product labels without

scientific backup.

 

McClellan said that FDA planned to step up scrutiny of supplements in nine

major categories, including supplements that claim to treat life-threatening

diseases--such as cancer, HIV/AIDS and lupus--as well as weight loss

products and autism treatments.

 

Supplements claiming to treat mental retardation, to prevent Alzheimer's

disease and to prevent hangovers could also be targeted, he said.

http://reuters.com/newsArticle.jhtml?type=healthNews & storyID=1931337