Fraud or find: a shopper's guide to food & supplement claims.
Cholestin, said the ad, is "an all-natural dietary supplement" that "has been clinically proven to lower cholesterol levels an average of 25 to 40 points in just eight weeks."
Several pages later, there's another ad about lowering cholesterol. But this one is for a drug.
"Pravachol is the only cholesterol-lowering drug of its kind proven to prevent a first heart attack," it explains.
Why take a drug if you can take a cheaper, natural supplement?
Cholestin and Pravachol contain similar ingredients. But there's a big difference: Pravachol and the other "statin" drugs have been tested for safety and effectiveness in multi-year trials on some 20,000 people.
Cholestin has been tested in three "major" studies. (All are in Chinese, so any information about them comes from the company.) They used "extracts" or a "crude form" of Cholestin, lasted eight weeks, and involved a total of 650 people. A U.S. study is under way.
Which claims on supplements have to be backed by strong evidence and which don't? Most people don't have a clue.
"Low-fat." "High-fiber." "Cholesterol-free." Most claims on food labels are about nutrients.
But, like drugs and supplements, foods can also make claims about health or disease. For example: * "...diets low in fat and high in vegetables, especially those containing vitamin A, C, or fiber, may reduce your risk of certain types of cancer!" (Green Giant Sugar Snap Peas). * "...a diet that is low in total fat, saturated fat, and cholesterol combined with a healthful lifestyle may reduce the risk of heart disease" (Tropicana 100% Pure Squeezed Orange Juice). * "...a healthy diet with enough calcium helps ... maintain good bone health and may reduce the risk of osteoporosis later in life" (Tums Antacid/Calcium Supplement).
Thanks to the Nutrition Labeling and Education Act (NLEA), the 1990 law that brought you "Nutrition Facts" labels, these so-called "health claims" are carefully regulated by the Food and Drug Administration (FDA). They can only appear on foods or supplements if the FDA decides that: * there is "significant scientific agreement" to back up the claim (so far, the FDA has approved ten), * the food has enough or not too much of the nutrient that's linked to the disease, and * the food isn't too high in some other damaging nutrient, like fat, saturated fat, cholesterol, or sodium and isn't an empty-calorie junk food.
That ensures that only healthy foods make health claims. Unfortunately, some companies don't want words like "cancer" or "birth defects" on their labels, no matter what. But at least when you see a health claim, you know that the FDA has approved it.
In 1994, under pressure from the supplement industry, Congress passed a law -- the Dietary Supplement Health & Education Act (DSHEA) -- that allows another kind of claim.
It's supposed to explain how a supplement affects the "structure or function" of the body. A classic example is "calcium builds strong bones and teeth." ("Calcium helps prevent osteoporosis" is a health claim, because it mentions a disease.)
To make a structure-or-function claim, a supplement-maker is supposed to: * notify the FDA, * have evidence (Congress didn't say how much) that the claim is truthful and not misleading, and * include the following disclosure on the label: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
So far, companies have notified the FDA that they're making hundreds of claims, but the agency rarely checks to see if enough evidence backs them up. "If we find one that's obviously egregious -- because it's making a drug claim -- then we send the company a letter," says Elizabeth Yetley, head of the FDA's Office of Special Nutritionals.
For example, an FDA letter has warned Soy Life that its claim ("evidence is mounting that soybeans may inhibit tumor growth") makes it "subject to regulation as a drug."
When the FDA sent a similar letter to the makers of Cholestin, the case ended up in court.
But even non-druglike structure-or-function claims can mislead consumers (see "The Claim Game," p. 10. Here's how: * No supplement ... no function. Some claims imply that the "function" doesn't occur unless you take the supplement. For instance, the supermarket chain Fred Meyer's brand of vitamins says that "vitamin A is a fat-soluble vitamin that is necessary for new cell growth and healthy tissues is essential vision in dim light."
True. A severe deficiency of vitamin A can cause blindness. It still happens to children in poor countries. But vitamin A won't help Americans see any better. * Body parts. When claims mention part of the body, they may imply that the supplement can prevent disease there. For example, when Nature's Herbs Power-Herbs Pygeum Power says that it "nutritionally supports healthy prostate function," shoppers may hear "shrinks an enlarged prostate" or, worse, "helps prevent prostate cancer." * "Maintain," not "treat." Many supplements use a word like "maintain" to avoid making a drug claim. "Correcting an abnormal condition is a drug claim," says Elizabeth Campbell of the FDA's Office of Food Labeling. "But maintaining a normal condition is a structure-or-function claim."
That subtle distinction is lost on many consumers. And for some claims, the distinction doesn't exist.
For example, Cholestin's label says that it "maintains" healthy cholesterol and that it "is not recommended for treating a disease."
But the label also says that the supplement "Reduces LDL `Bad' Cholesterol." If that isn't "treating" high cholesterol, what is? * Skimpy evidence. How much evidence does a company need to make a claim? One good study? Two lousy studies? A study that's under way? Congress didn't say ... so almost anything goes.
The bottom line: Buyer beware. "I'm not sure that all consumers recognize that the claims they're relying on are not evaluated by the FDA to see if they're based on sound science," says Robert Moore, Senior Regulatory Scientist at the FDA.
"Guaranteed bacterial antiadherence activity for the urinary tract," says the label on Solaray CranActin Cranberry AF Extract. But the package has no disclaimer that the "FDA hasn't evaluated this statement."
Does that mean that the FDA has evaluated the evidence, and that it's solid? You should be so lucky.
For every new structure-or-function claim on supplement shelves, you can probably find a similar claim without the disclosure ... and with no more scientific support.
Think of them as "look-the-other-way" claims. For years, supplement-makers have banked on the FDA's tendency to look the other way when it comes to claims. And they still do.
Many look-the-other-way claims are "name claims." Futurebiotics Hair, Skin & Nails says nothing about making your hair silky, your nails strong, and your skin wrinkle-free. With a name like that, it doesn't have to.
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|Publication:||Nutrition Action Healthletter|
|Date:||Sep 1, 1997|
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