Dietary Supplements

What are they? Dietary supplements are products taken as a supplement to the diet. Examples are vitamins, minerals, herbs, botanicals, and amino acids, the individual building blocks of proteins needed for all life. Dietary supplements are classified as foods and not drugs.

Problem sites: Web sites cannot claim that dietary supplements will prevent, treat, or cure any disease. This would make the product an unapproved and illegal drug. Also, Web sites can't make claims that a dietary supplement will have an effect on any structure or function of the body when the claims are not substantiated.

"Web sites selling dietary supplements with false or unsubstantiated claims sometimes use testimonials and advertisements touting a quick, miracle cure," says the FTC's Cleland. "And some sites claim a product will cure it all--heart disease, cancer, arthritis, you name it."

Cleland says he sees a lot of miracle claims for major diseases and weight loss. "Criminals also prey on people's fears about terrorism," he adds. After the anthrax attacks in 2001, some sites falsely claimed that dietary supplements such as colloidal silver and oregano oil could protect against biological and chemical contamination.

Risks: "In promoting some products, companies are telling patients not to undergo surgery, chemotherapy, or other needed treatment," says Cleland. "So we are concerned about people forgoing legitimate medical treatment."

Consumers also have to worry about ingesting harmful substances. Companies may call a product "natural," but that doesn't mean it's safe. And dietary supplements are intended to supplement diets, not replace them. Too much of some nutrients can cause problems. There is also a danger of dietary supplements interacting with other drugs you may be taking. The prescription medicine warfarin, the herbal supplement gingko biloba, aspirin, and vitamin E all can thin the blood, so taking any of them together can increase the potential for internal bleeding.

Regulation: Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are products that are intended to supplement the diet and that contain one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance that supplements the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combination of these ingredients.

Dietary supplement manufacturers must notify the FDA at least 75 days before marketing products containing some "new dietary ingredients." This includes providing the agency with safety information about the supplement. New dietary ingredients are those that were not marketed as dietary supplements before Oct. 15, 1994.

Except for those dietary supplements containing new dietary ingredients, the safety and labeling of most dietary supplements is monitored only after they reach the marketplace. The FDA evaluates the safety of dietary supplements after they are on the market, overseeing safety, manufacturing, and product information on the labeling. The FTC regulates the advertising of dietary supplements under the FTC Act, which prohibits deceptive claims in advertising.

Under DSHEA, the FDA generally has responsibility for showing a dietary supplement is unsafe before it can take action to restrict the product's use. For example, in 2004, the FDA banned the use of ephedrine alkaloids in dietary supplements because the substances pose an unreasonable risk of illness or injury. Ephedrine alkaloids in dietary supplements have been linked to cardiovascular problems.

"If the FDA can establish that claims are false or misleading, or if a firm is making drug claims for a dietary supplement, the agency can take action using any of our enforcement tools, such as warning letters, cyber letters, seizure of products, and criminal prosecution," says Jennifer Thomas, who leads the dietary supplement and labeling enforcement team in the FDA's Center for Food Safety and Applied Nutrition, Office of Compliance.

Consumers should be wary of claims related to diseases or conditions that are prominent in the news. For example, when Severe Acute Respiratory Syndrome (SARS) was in the news in 2003, the FDA found several dietary supplement products promoted on the Internet for treating or preventing SARS. The FDA took action against 10 of these firms, as there was no evidence of safety or effectiveness of the products for use against SARS.

Enforcement Examples:

• Since 2003, the FDA has taken action against street drug alternative products called "Black Beauties" and "Yellow Jackets," seizing millions of dollars worth of these products. Although labeled and marketed as dietary supplements, such products are actually unapproved drugs and cannot be sold as dietary supplements.
• In February 2004, the FDA warned consumers against purchasing a liquid product called "Green Hornet." Although it was promoted on the Internet and sold in stores as a dietary supplement, the product was actually an illegal drug because it was promoted as an herbal version of Ecstasy. After taking the product, four teen-agers were rushed to the hospital with seizures, excessive heart rates, severe body rashes, and high blood pressure.
• In March 2004, the FDA and the FTC announced that SeaSilver USA Inc. and Americaloe Inc. of Carlsbad, Calif., signed a consent decree of permanent injunction and agreed to stop manufacturing a bogus cure-all liquid supplement called SeaSilver and other products.
• In June 2004, the FDA announced the sentencing of a man who swindled cancer patients by heavily advertising and selling Laetrile, also known as vitamin B-17 or apricot pits. Although he purported it to be a dietary supplement, Laetrile is actually an unapproved drug. The highly toxic product hasn't shown any effect on treating cancer.
• The FDA issued a warning letter to Cellular Wellness Foundation in September 2004, citing claims made on its Web site that the product Cellular Tea was effective in treating serious diseases such as cancer.
• In 2004, the FDA issued warning letters to 25 firms that promote their products on the Internet with claims that the products are useful for weight loss. The claims are not supported by scientific evidence.
• In July 2004, the U.S. District Court for the District of New Jersey found that three products sold by Lane Labs-USA Inc. and its president Andrew J. Lane as dietary supplements and a cosmetic--Benefin, MGN-3, and SkinAnswer--are in fact unapproved new drugs under federal law because they were being marketed as treatments for cancer, HIV, and skin cancer without FDA approval. The court permanently enjoined Lane and the company from distributing Benefin, MGN-3, and SkinAnswer unless they are first either approved for marketing by the FDA or distributed pursuant to an investigational new drug application for purposes of conducting a clinical trial. The court also ordered the defendants to pay restitution to purchasers of the three products since Sept. 22, 1999. The defendants are appealing the court's decision.

Tips: Consumers who choose to buy dietary supplements on the Internet should consider who operates the Web site and what evidence is provided to substantiate claims.

Dietary supplement makers are responsible for making sure that their products are safe before they go on the market and that claims on labels are accurate, truthful, and substantiated with adequate scientific evidence. By law, supplement manufacturers are allowed to use these types of claims, when appropriate:

• Nutrient-content claims such as "high in calcium" or "excellent source of vitamin C."
• Health claims that show a link between the supplement and reduced risk of a disease or health condition, when the use of the claim has been approved by the FDA. For example, women who get adequate amounts of the B vitamin folic acid during pregnancy have a decreased risk of having a baby with a neural tube defect.
• Qualified health claims, which are for dietary supplements only and came about as a result of a 1999 decision by the U.S. Court of Appeals for the District of Columbia Circuit in the case of Pearson v. Shalala. The court's ruling requires the FDA to allow appropriately qualified health claims that would be misleading without such qualification. These qualified claims are based on the weight of the scientific evidence. An example of this type of claim is "supportive but not conclusive research shows that consumption of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) omega-3 fatty acids may reduce the risk of coronary heart disease."
• Claims regarding a benefit related to a classical nutrient deficiency disease, such as vitamin C and scurvy.
• Claims that a dietary supplement has an effect on the structure or function of the body, when such claims are supported by scientific evidence. An example of such a claim is "calcium builds strong bones" for a supplement that contains calcium.
• Claims that describe general well-being from consumption of the product.

The FDA recommends that consumers contact their health care providers before using dietary supplements. This is especially important for people who are pregnant or breast-feeding, chronically ill, elderly, under 18, or taking prescription or over-the-counter medicines.