Publication: FDA Consumer Publication Date: 01-NOV-06 Delivery: Immediate Online Access Author: Meadows, Michelle
Article Excerpt On April 19, 2006, the Federal Trade Commission (FTC) led a massive "Hispanic Multimedia Surf" to identify potentially fraudulent advertising aimed at Spanish-speaking consumers. More than 160 participants from government agencies and Hispanic consumer and student groups "surfed" the Internet, Spanish radio and television broadcasts, and print media for deceptive advertising in the areas of credit, work opportunities, and health.
"The FDA's role in the surf was to focus on unapproved products with claims to cure, treat, or prevent serious diseases such as diabetes, cancer, HIV/ AIDS, and heart disease," says Gary Coody, national health fraud coordinator in the Food and Drug Administration's Office of Enforcement. More than 30 Spanish-speaking employees from the FDA's headquarters in Rockville, Md., and 14 FDA district offices nationwide and in Puerto Rico participated.
The FTC released results of the project in September 2006, reinforcing the need for consumers to recognize the signs of health fraud and to communicate with their doctors before using new medical products.
"Diabetes-related ads were prevalent," according to Laura Koss, an FTC senior attorney who coordinates the agency's Hispanic Law Enforcement and Outreach Initiative. "We also observed that many of the advertisements were for 'natural' or 'herbal' alternatives to traditional medicine. And many ads promoted cure-alls, products that promise to cure a wide variety of ailments including diabetes, asthma, and depression."
Whether an ad runs in English or Spanish, the characteristics of health fraud are the same, Coody says. A product is promoted as offering some type of health benefit, but the claims have not been scientifically proven. The product may be ineffective or even harmful.
Promoters of fraudulent products employ a wide range of tactics--aggressive advertising, reliance on personal testimonials, pseudomedical jargon, dubious science and so-called "experts," and claims of revolutionary or exotic ingredients.
"The same ad that clearly looks like a scam to one consumer may attract someone else who is vulnerable," Coody says. "Some companies go after people with serious conditions who are desperate for a cure, or they go after people who want a quick fix."
The FDA sent a Warning Letter to one foreign-owned Web site touting an unapproved product, "The Antidote." Purportedly derived from the blood of crocodiles, the Antidote was promoted as a drug, with claims that it can treat cancer, AIDS, and other life-threatening diseases. "The miracle healing powers of the Antidote can now be used to fight all known human viruses and bacteria...," "the Web site claimed. This product violated the Federal Food, Drug, and Cosmetic Act because it failed to comply with applicable licensing and pre-approval requirements. The FDA issued an Import Alert intended to prevent all shipments of the Antidote from entering U.S. borders.
The FDA also warned another firm that marketed a product "Viralsol." The firm's Web site claimed the product could treat herpes and HIV/AIDS. Patients were instructed to take varying amounts of Viralsol based on their viral load. "The FDA considers Viralsol to be an unapproved new drug," Coody says. "Before a new drug may be legally marketed, it must be approved by the FDA." Drug sponsors must submit scientific data to demonstrate that a drug is safe and effective.
In 2005, the FDA sent Warning Letters to 29 businesses making unproven health-related claims about fruit products on their Web sites and on product labels. The companies marketed dried fruit, fruit juice, and juice concentrate for treating and preventing cancer, heart disease, arthritis, and other diseases.
"Warning letters are one of the primary tools for the FDA to achieve voluntary compliance," Coody says. "When companies fail to heed warning letters or if their actions pose serious health risks, the agency can take more formal measures." Such measures could include criminal prosecution, seizure of goods, and injunction against a firm or individual responsible for marketing violative products. An injunction is a civil action taken to stop production or distribution of a product that violates the...
NOTE: All illustrations and photos have been removed from this article.

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