FDA posts information regarding regulation of supplements
ROCKVILLE, Md. Countering the misconstrued notion that dietary supplements are unregulated in the United States, the Food and Drug Administration on Monday posted to its site a detailed explanation not only as to how supplements are regulated, but how those regulations are enforced.
“Federal law requires that every dietary supplement be labeled as such, either with the term ‘dietary supplement’ or with a term that substitutes a description of the product’s dietary ingredient for the word ‘dietary’ (e.g., ‘herbal supplement’ or ‘calcium supplement’),” the FDA stated.
And while no supplement manufacturer is required to submit safety or efficacy data in support of its product before going to market, those products are still regulated. Any supplement advertisement claims, for example, are vetted by the Federal Trade Commission, and the FDA pays close attention to any safety flags. “Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion,” the agency stated.
Council for Responsible Nutrition adopts DHEA marketing guidelines
WASHINGTON The Council for Responsible Nutrition announced Monday that its members have adopted a new voluntary program for responsible marketing of dehydroepiandrosterone, an ingredient in many sports nutrition products also known as DHEA.
Under the new program, CRN members agreed to refrain from marketing DHEA products as providing benefits like those of general anabolic steroids, such as muscle enlargement and increase strength. They also agreed not to market the products to children because the chemical is unlikely to enhance their performance.
“This is an important step forward in self-regulation by the dietary supplement industry, and we encourage other companies to join our members in following these guidelines,” stated CRN President and CEO Steve Mister said. “It’s disturbing to see some of the ads in magazines or online that promote DHEA as if it were a drug or anabolic steroid, when the fact is existing research has not demonstrated that kind of effect.”
In 2004, Congress enacted the Anabolic Steroid Control Act, which placed a number of steroid precursors on the Controlled Substances List. Congress omitted DHEA from the list, recognizing that it doesn’t enhance performance or lead to the abuse, addiction or side effects that anabolic steroids cause. Unlike anabolic steroids, DHEA is natural and is the most common steroid hormone in the body. The body recognizes when it achieves normal hormone levels and ignores additional DHEA.
“Research demonstrates that in young, healthy adults, supplemental DHEA does not affect testosterone levels and does not provide performance-enhancing benefits, therefore, it should not be marketed as having an anabolic steroid effect,” Mister said.
According to Nutrition Business Journal, U.S. annual sales of DHEA are $49 million, CRN said.
Severe sleep apnea increases risk of death
WASHINGTON Sleep apnea can do more than interfere with a sound sleep—it can also increase risk of death, according to a report.
The report, published in the journal Sleep, was the result of an 18-year study that found sleep apnea increased the risk of death from any cause by causing the person’s health to deteriorate over time.
The research team that conducted the study examined 1,522 men and women aged 30 to 60. Among the control group, the death rate was 2.85 per 1,000 people each year. Among those with mild to moderate sleep apnea, it was 5.54 and 5.42 per thousand, while the rate was 14.6 per thousand among those with severe sleep apnea. More than 40 percent of deaths among those with severe sleep apnea resulted from cardiovascular disease.
The National Heart, Lung and Blood Institute estimates that sleep apnea affects 12 million to 18 million Americans.