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Legal Impact

Some recent food and drug enforcement actions highlight two things: first, the importance to compliant companies of tough government enforcement against those companies that don't comply with the law, and second, the central concept of "intended use," which is an exceedingly important, sometimes counter-intuitive and ultimately fascinating centerpiece of the way the law defines these products.

The U.S. Food and Drug Administration and the Federal Trade Commission have been reasonably active in going after some of the more egregious examples of products that make what are legalistically referred to as unsubstantiated, false or misleading claims, and are more casually referred to as bull.

Last month, we examined trends in FDA enforcement and some of the recent political issues that are making life complicated for the agency (see PD, Nov. '05, p. 22). This month, we'll take a closer look at the enforcement steps that FDA and FTC are directing against what they contend are some of the phoniest products and claims around.

And, when it comes to traditional foods and dietary supplements, these enforcement actions are an even more essential part of the regulatory scheme than with drug products, since traditional foods and dietary supplements are not approved by FDA or any other agency before they enter the market.

The law places the burden on the product's marketer to assure that the product is made in accordance with current Good Manufacturing Practices and is labeled in accordance with the law and regulations, and that they have substantiation for any label claims that they make for the product, especially those claims relating to health conditions. Companies whose products won't hit the market until all the necessary conditions are met should not have to compete with the fast-and-loose crowd.

The law permits some foods and dietary supplements to make some specified claims of effect on specified diseases, but generally speaking, such claims are off limits. Dietary supplements and traditional foods can make claims of effect on the structure or function of the body, but marketers need substantiation that the claim is true, and they need to give FDA notice that they are making the claim.

Also, FDA's late October and early November salvos against fruit products and "alternative hormone therapies" are excellent examples of the slightly nutty, metaphysical truth at the center of food and drug law. It is this: If your product is labeled with a claim that says it can cure or treat a disease, the law says your product is a drug.

It doesn't matter if your product is a jar of cherry juice, a tube of skin cream or a glass of water. That's because the law says that an article is a drug if it is intended to do something about a disease or to affect the body's structure or function, among other things. Those who tend to think a product won't legally be regulated as a "drug" unless it chemically contains a substance the medical profession thinks of as a drug are often unpleasantly surprised.

So it is, then, that 29 different marketers of products made from cherries and other fruits got the bad news in October. FDA notified them that their fruit juice concentrates, dried fruits and the like, which had been sold with labels touting their benefits in fighting cancer, heart disease, arthritis, gout and other diseases, were drugs. And they were illegal drugs, to boot, because they were "new drugs" lacking FDA preapproval for marketing. These FDA Warning Letters told the companies—as such letters typically do—that FDA thought that the companies were violating the law, and threatened product seizure, injunction against sales and criminal prosecution if they didn't cut it out.

Also, FDA told 16 different companies and FTC told 34 websites to cut out their touting of dietary supplements and hormone creams for reversal or prevention of osteoporosis, cancer and other diseases.

At the root are the agencies' assertions that the companies' claims are false. False statements about a product's ability to prevent or cure one or more heartbreaking, serious diseases prey on vulnerable, desperate people who might forego legitimate preventions or cures and waste their money on the phony product.

The Federal Food, Drug and Cosmetic Act outlaws the sale of food or drugs with labeling that is false or misleading in any particular. False statements in commercial settings are not accorded the protections of free speech guaranteed by the U.S. Constitution. Certain authors of best-selling "natural cures" books would be well advised to remember that as they incessantly wonder why people want to shut them up. Sincerity of belief in a product's effect is not, to put it mildly, the scientific standard of proof.

In addition to these actions, the FTC has recently shut down sales of weight loss products and other dietary supplements making false claims of effect.

You often hear it said that business needs a "level playing field." That phrase is interpreted in various ways. A level playing field for companies trying to comply with the law can be maintained if FDA and FTC stay diligent in combating unsubstantiated claims and products.

Eric F. Greenberg is principal attorney with Eric F. Greenberg, PC, with a practice concentrated in food and drug law, packaging law and commercial litigation. Visit his firm's website at Contact him by e-mail at [email protected], or by phone at 312/977-4647.

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