A string of recalls due to marketers' failure to disclose dangerous ingredients, which can be harmful when taken in combination with other drugs, have highlighted the risks to consumers seeking alternative treatments that claim prescription-strength results.And in recent years, the FDA has warned or enjoined from doing business, a number of companies that market supplements because of unsupported claims that the pills could cure serious and chronic medical conditions. The promotional materials often fail to mention dangerous chemicals that are identical or similar to those found in prescription drugs, and that could be harmful unless they are used in a controlled way.
"These tainted products can cause serious adverse effects, including strokes, organ failure and death," said FDA Commissioner Margaret A. Hamburg in a statement. "The manufacturers selling these tainted products are operating outside the law."
According to the letter, FDA lab tests have revealed a startling variety of undeclared active ingredients in dietary supplements, including anticoagulants, anticonvulsants, inhibitors, anti-inflammatory drugs and beta blockers, as well as pharmaceutical components removed from the market for safety reasons and new chemicals of unknown safety. Some of the products have been found to contain controlled substances such as anabolic steroids.
Products that carry undeclared ingredients or bear misleading claims about curing disease are illegal because they are tantamount to unapproved new drugs or adulterated dietary supplements. By contrast, lawful dietary supplements contain minerals and vitamins and are intended to be an addition to a standard diet.
"Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails," said FDA spokesman Michael Levy.
The most common categories favored by marketers of illegal supplements are weight loss, sexual enhancement and body building. Regulators say the unapproved pills not only pose risks to consumers, but undermine confidence in legitimately marketed dietary supplements in these and other categories.
Leading Consumer Ally's round-up of recent incidents of contaminated dietary supplements is the withdrawal this week of a product with the bold name Man Up Now. The Food and Drug Administration, in its warning to consumers not to use it, said the capsules contain an undeclared chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, the chemical - sulfoaildenafil - may cause dangerously low blood pressure when taken together with nitrates and lead to inadequate blood supply to the brain, resulting in dizziness and light-headedness.
Man Up Now, which is distributed by Synergy Distribution LLC, claims to be "herbal" and "all natural," and consumers may easily assume it poses no health risk. The pills are sold on Internet sites, online outlets and possibly in retail outlets in single, double and triple blister packs, and in six- , 12- , and 30-count capsule bottles.
In October, the FTC filed a lawsuit against Wellness Support Network Inc., an online marketer of two dietary supplements that purport to treat and prevent diabetes. Ads on the company's website described both products as "Completely Natural!" and referred to them as a "diabetes breakthrough," but the FTC contended the claims behind the products were false or unsupported by scientific evidence.
Also in October, the FDA enjoined Risingsun Health, a Montana company, from selling unproven treatments for breast cancer, asthma, anemia and epilepsy. Risingsun distributed a variety of products with names such as Black Salve, Cancema and Can-Support, none of which were effective for the conditions they claimed to treat, the agency said.
In September, POM Wonderful, maker of the bordeaux-colored pomegranate juice beverage, was slapped with a lawsuit by the Federal Trade Commission, which accused the company of lying to consumers about the drink's health benefits. Those included a claim that POM was 40% as effective as Viagra, although no clinical studies had been done to substantiate such a claim.
Data from an independent testing organization that came out that month showed that almost 30% of 24 brand-name supplements failed to meet quality standards for contamination, freshness and active ingredients.
In August, the FDA warned against another dietary supplement sold online and marketed as a sexual enhancement aid. TimeOut Capsules, which were labeled as "100% natural," were found to contain hydroxythiohomosildenafil, a chemical similar to Viagra's sildenafil, and the agency urged consumers to stop using them immediately.
Consumer Ally also reviewed a recent report that said of the more than 54,000 dietary supplements on record, only one-third have been vetted as safe. According to Nutrition Business Journal, Americans spent $26.7 billion on supplements in 2009.
In June, Magic Power Coffee, an instant coffee marketed as a dietary supplement for sexual enhancement, became the target of an FDA warning for containing the same undeclared, potentially dangerous drug ingredient as TimeOut Capsules. It billed itself as "the world's first passion coffee" and claimed to work as an aphrodisiac on both sexes.
The FDA does not have the authority to regulate dietary supplements, because they are not considered drugs and as such fall outside the agency's jurisdiction. Its letter to the dietary supplements industry this week enlists five major trade associations to aid the agency in emphasizing the legal obligations and responsibilities of marketers and to prevent tainted products from reaching the U.S. market.