In addition to FDA’s qualified health claim initiative, it has also begun enhancing enforcement activities against dietary supplement manufacturers and others that make misleading claims about health benefits that are not based on science. In the six months since FDA launched its enhanced enforcement initiative, it has taken the following actions against products that make unsubstantiated or misleading claims about the health benefits of their products:

• Issued 73 warning letters and cyber letters against companies making unsubstantiated claims;
• Initiated actions that led to four seizures of products making false and misleading claims;
• Signed a legally-binding consent decree requiring a firm to destroy all of its seized unapproved and misbranded drugs;
• Increased actions against dietary supplements that contain unapproved drugs—specifically, the Agency took legal action against dietary supplements containing lovastatin (a cholesterol-lowering product), sildenafil (the active ingredient in Viagra) and tadalafil (the active ingredient in a product approved in Europe for erectile dysfunction);
• Working with the FTC, FDA promptly warned manufacturers and operators of websites to stop making deceptive or misleading Internet claims that their products prevent, cure or treat SARS; and
• Greatly enhanced its collaborative efforts with the FTC and other consumer protection and law enforcement agencies to remove from the marketplace those products that make unsubstantiated claims—in the effort against bogus SARS products, FDA, FTC and the government of Ontario surfed scores of websites and found more than 40 companies making bogus claims for their SARS products.

Altogether, FDA’s strong enforcement efforts since December of last year have led to the seizure of products worth almost $9 million.

Following on the heels of FDA’s update of its enforcement activities, Senator Tom Harkin (D-Iowa) and Senator Orrin Hatch (R-Utah) introduced legislation to increase funding to enable FDA to fully implement the Dietary Supplement Health and Education Act (DSHEA). The DSHEA Full Implementation and Enforcement Act (S. 1538) would provide FDA with the funding it needs to ensure the 1994 law is carried out as Congress intended. It would also increase funding for the National Institutes of Health’s Office of Dietary Supplements—which was created by DSHEA to expand research and provide consumer information on dietary supplements—from $20-30 million annually. According to NNFA, Newport Beach, CA, the DSHEA Full Implementation Act would appropriate a total of $205 million to FDA over the next five years, beginning in 2004 with $20 million and increasing annually. This funding, which is specifically earmarked for implementation of DSHEA, more than doubles in its first year the amount appropriated in 2003 for the same purpose. The bill also requires FDA to submit a written report to Congress each year detailing how the agency is using its resources to regulate supplements.

FDA has approved the first qualified health claim for nuts, saying that eating 1.5 ounces of most nuts per day may reduce the risk of heart disease when they’re part of a diet low in saturated fat and cholesterol. The claim states specifically: “Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts [,such as Name of specific nut,] as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease.” The claim is one of only six existing claims relating to heart disease and is the result of rigorous review of a large body of scientific research citing the heart health benefits of nuts. The claim is a result of a petition filed by the International Tree Nut Council Nutrition Research and Education Foundation.