FDA destroys steroid products sold as supplements
ROCKVILLE, Md. The U.S. District Court for the Eastern District of Michigan, Southern Division, on Monday entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements.
“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” stated Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”
At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”
Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury. Specifically, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels.
The FDA has no scientific information concerning the safety of the condemned products or their ingredients and, thus, cannot determine whether they represent a hazard to consumers. Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals.
The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use.
New warnings added to prescribing information for cancer drug
ROCKVILLE, Md. The Food and Drug Administration last week posted a notification to healthcare professionals around the safety profile of the cancer drug Tarceva to its MedWatch Web site.
Adverse events associated with the drug include gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva.
The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports, the FDA stated.
Durex introduces new product to lubricants line
ATLANTA Durex last week introduced a new product to their Play range of lubricants that adds a burst of flavor to the line.
The new Flavor Fusion personal lubricant from Durex Play combines two flavored lubricants in one package — pina colada and passion cherry.
The smooth gel lubricants are sugar free, smooth and non-sticky, clear and non-staining, water soluble and safe to use with condoms
Durex category research has found a high interest level among consumers in experimenting with flavored lubricants, as high as 62%.