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Food, supplement, or drug?

What to make of nutraceutical claims

Last updated: July 2011

Federal Trade Commissioner Julie Brill answers questions about nutraceutical products.

When food products or dietary supplements claim to prevent or cure a disease, the Federal Trade Commission takes action. The FTC examines claims made by manufacturers of those products, sometimes marketed as "nutraceuticals," and some of the investigations have lead to charges of false advertising.

For example, the FTC charged the makers of POM Wonderful with falsely advertising that its pomegranate juice will prevent or treat heart disease, prostate cancer, and erectile dysfunction. That case is still ongoing. In another case, Dannon was forced to drop claims that its probiotic yogurt Activia relieves irregularity, and that its drinkable yogurt DanActive helps prevent colds and flu. And an action against Kellogg's resulted in an order that prohibits the cereal maker from claiming that Rice Krispies can boost children's immunity. Kellogg's cannot make any claims about the health benefits of any food unless the claims are backed by scientific evidence and are not misleading.

To help navigate the world of nutraceuticals, we talked to FTC Commissioner Julie Brill.

Q: What are nutraceuticals, and how does the FTC review the claims that these products make?
A: Nutraceutical is a word that was made up by the natural products industry, although it has now made it into the dictionary. It's a food or dietary supplement that purportedly has health benefits beyond nutritional value. Some claim to help the immune system, or that they will help prevent colds, flus, things like that. We've seen claims about preventing cancer, shrinking tumors, and doing other amazing things.

The FTC doesn't approve or disapprove of product claims before a product goes on the market, but once it's for sale and claims are made about it, we can take a look. When an issue comes to our attention we try to determine whether the claim is substantiated.

Q: How does the FTC decide which complaints to investigate?
A: We receive all sorts of complaints about food and dietary supplement products. First we look at the populations being targeted. That's a very big issue for us. If they are vulnerable populations like kids, cancer patients, or HIV patients, we might take a closer look at that product. If it's a claim that's being made in mass media, or that appears to be generating a lot of interest, and we are suspicious of the substantiation, we might take a look at that too.

Q: What is the FTC doing to make sure that manufacturers use legitimate scientific research to tout their product's benefits?
A: Companies must have a reasonable basis for the claims that they make about their products. This means that advertisers must have reliable scientific evidence to support their claims. If a claim is about a disease, animal studies will not be enough. Tests on humans are required, and in cases two clinical trials may be needed. It very much depends upon both the product and the claim that's being made. We've seen some claims about cereal, for instance, where product manufacturers—very large manufacturers—were claiming that the cereal would improve kids' attentiveness and things like that. We've seen other products where the manufacturers have claimed that their products would prevent flus and colds, and keep kids from having sick days. In those instances we would require human clinical trials.

Q: What does the FTC do to ensure that testimonials are balanced with realistic expectations?
A: In October of 2009 the FTC issued new guidelines for testimonials and endorsements. We said that testimonials would have to demonstrate the typical consumer's experience. It used to be that advertisers were able to say, "results not typical," or "results may vary." After careful analysis in terms of how consumers interpreted testimonials, even with the disclaimer "results may vary," we found that consumers were taking the claims to be the typical result. So we determined that the disclaimer would no longer be appropriate. We recently brought a series of cases against acai berry advertisers and websites that looked a lot like newspaper websites but we alleged were just advertisements filled with false testimonials about what acai berries could do.

Q: It can be difficult to distinguish between general health claims and more specific claims that a product can actually treat or cure a condition. How can consumers decipher the claims?
A: The first and foremost advice that we give consumers is to be skeptical about health claims for foods and dietary supplements. Recognize that there is no magic bullet. The best thing that consumers can do is to have a balanced diet and, of course, to exercise. There are red flags that should go off when particular types of words and phraseology are used, such as "miracle cure," "newly discovered," or "ancient remedy." Other warning signs include urging consumers to buy quickly ("offer won't last") or that a product is "risk free" or has a "money-back guarantee". Whenever a consumer is not sure about whether a dietary supplement or food product will do what is being said about it, we urge them to consult with their physician or with their pharmacist. Sometimes a dietary supplement could actually have an adverse effect, depending upon what other products or prescriptions the consumer is taking.

This report was made possible by a grant from the Airborne Cy Pres Fund, which was established through a legal settlement of a national class-action lawsuit (Wilson v. Airborne Health, Inc., et al.) regarding deceptive advertising practices.

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