|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
March 10, 1998
WARNS CONSUMERS AGAINST TAKING DIETARY SUPPLEMENT "SLEEPING BUDDHA"
The Food and Drug Administration is warning
consumers not to purchase or consume a product known as Sleeping Buddha. The product,
which is being marketed as a dietary supplement, contains an unlabeled prescription drug
ingredient that poses possible health risks. The product also has not been submitted to
FDA for review or approval for any of the uses for which it is being sold.
Sleeping Buddha is marketed in capsule form as a
product of China and labeled as imported and distributed by Treasure Box Products Inc. of
Burnaby, B.C., Canada. The product is being promoted for insomnia and restlessness and is
sold as an herbal alternative to prescription sedatives.
FDA has determined that the product actually contains the
prescription-strength drug ingredient, estazolam, which is a sedative of the
benzodiazepine family. Estazolam is known to have serious side effects, including the
potential to cause fetal damage if a pregnant woman consumes the drug.
Also, because this product is a sedative, it poses a special risk to consumers who take
the drug while driving, while operating heavy machinery, or while taking other sedative
drugs or alcohol.
FDA has not received any reports of injury or adverse reactions from this product.
However, all consumers, and especially pregnant women, should be aware of the risks
associated with this product.
Treasure Box Products Inc., in response to U.S. and Canadian government testing, has
initiated a voluntary recall of all their products sold in the United States. FDA, in
conjunction with Canada's Therapeutic Products Directorate, will be monitoring this
Consumers who have used this product and have medical concerns should consult with their
health care providers.