Microsoft word - dietarysupp.doc

Alameda County District Attorney Combats Fraud and Unscrupulous Dealings in the 20
Billion Dollar Dietary Supplement Market
The Alameda County District Attorney’s Office is protecting consumers from dangerous and ineffective diet supplements. As part of a ten county task force that regulates and investigates the over the counter healthcare supplement market in California, the Alameda County DA’s Office investigates the industry for false, unsubstantiated or misleading advertising, labeling violations and unapproved drug claims. American consumers spend over 20 billion dollars a year on dietary supplements, herbs, minerals and multi-vitamins. California is the largest state market for these over the counter supplements. The supplement industry can market and sell these over the counter healthcare supplements products without proof of their effectiveness or safety for human consumption while the federal government can only act against a product if they have scientific proof the product is dangerous or harmful to consumers. State action is necessary in this area because the Federal government by law does not regulate the dietary supplement market in any meaningful way. A dietary supplement can be sold in the United States without prior government approval or proof that it is either safe or effective for its intended use. The task is made up of the following counties: Napa, Marin, Monterey, Orange, Santa Clara, Santa Cruz, Shasta, Solano, and Sonoma. Together, they enforce state laws that require advertising claims to be substantiated by concrete evidence. If companies make health related claims about their products they need to be able to support those claims with scientifically valid studies. If a company can not adequately substantiate an advertsiing claim then they are in violation of California’s Fair Advertising Law. (Business and Professions Code § 17500.) Another common violation investigated by the task force involves the mislabeling of dietary supplements. Our investigations have revealled that companies will make representations on their labelling that their products contain certain ingredients and yet scientific tests fail to detect any measurable amount of these ingredients. This has been particularly true where there has been a new super product to promote weight loss, like Hoodia gordonii. Hoodia gordonii first came to the public’s awareness in November 2004, when the television show 60 Minutes reported on the use of a native succulent plant, known as Hoodia gordonii, to suppress hunger. The story reported how the San tribesmen in the Kalahari Desert of Southern Africa used Hoodia gordonii to suppress appetite on long journeys. The tribesmen reported that they cut off parts of the Hoodia plant and sucked on it during long walks and that it curbed their appetite and increased their energy. Partially as a result of this news story, numerous companies began to produce pills, capsules, gel caps and liquids that allegedly contained Hoodia and marketed them to consumers as appetite suppressant and weight loss products. This created a demand and a corresponding price increase for Hoodia. Products that advertised they contained Hoodia were much in demand and the supply of Hoodia, an endangered plant, became much more limited. Some suppliers began substituting less expensive material and claimed it was Hoodia. It should be noted that although billions of dollars of Hoodia diet supplements have been sold in the United States over the last several years there has never been a scientifically valid study confirming that these products suppress appetite, increase energy or promote weight loss. The District Attorney’s task force has investigated and filed lawsuits against many companies for selling products that falsely claimed to contain Hoodia or that made unsubstantiated claims about weight loss. In a recent case filed in Solano County, the task force obtained a preliminary injunction from the Superior Court barring defendant Breakthrough Nutrition, a Florida corporation, from selling their product Dex L-10 in the state of California because it was misbranded. In issuing the injunction, the Court specifically found that it is reasonably probable that the district attorneys will prevail in proving that the DEX-L10 products contained no Hoodia gordonii and that, as a result, defendant Breakthrough manufactured, marketed and sold misbranded products in violation of California law. The dietary supplement industry frequently runs afoul of state and federal regulation when they make “desease claims”. If a dietary supplement claims to cure, mitigate, or treat a disease, it would be classified as a drug by the FDA regulations and could not be sold or marketed in the United States without FDA preapproval. The types of claims that move a dietary supplement from the “food” category to the “drug” category involve representing the product as a treatment, prevention or cure for a specific disease or condition. The task force has investigated and prosecuted companies for claiming their products can mitigate or treat diseases such as cancer, diabetes, osteoarthritis, and rheumatoid arthritis without obtaining FDA appproval before marketing these products to California consumers. The Alameda County District Attorney is committed to doing all it can to protect Consumers from unscropulous and unfair business practices. Individual consumers should be suspicious of claims made for nonperscription healthcare products because these claims have not been approved by the FDA and may in fact be untrue. Consumers should not buy products based on advertisments they have seen without doing research on the effectiveness or safety of the product. Consumers should consult their healthcare provider before taking over the counter supplements. The Internet can be a good resource for people to investigate healthcare products but be mindful that many websites are simply commercial platforms used to sell these same products. A consumer using the Internet for research should be looking for government or nonprofit websites that are not trying to sell a product with their reviews. Here are the links for the relevant FDA and California Department of Public Health websites. http://www.fda.gov/Food/DietarySupplements/default.htm and http://www.dhs.ca.gov/fdb/

Source: http://www.alcoda.org/news/files/dietarysupp.pdf