The FDA has announced that U.S. Marshals, at the agency’s request, seized almost 90,000 bottles of dietary supplements that contain kratom, a botanical substance that poses a risk to public health. This plant, whose Latin name is Mitragyna speciosa, grows in Thailand, Malaysia, Indonesia, and Papua New Guinea. It is toxic to multiple organ systems.
Consumption of kratom can lead to respiratory depression, vomiting, nervousness, weight loss, and constipation. It has narcotic and stimulant effects and causes withdrawal symptoms, including hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.
The FDA issued an import alert last year to let U.S. officials detain imported dietary supplements and ingredients that contain kratom without physical examination. This month, the FDA detained RelaKzpro under the FD&C Act, as amended by the Food Safety Modernization Act. These acts let the agency detain foods or supplements if the agency believes the product is adulterated or misbranded. And the FDA can keep the products out of the marketplace for 30 days while it decides whether to take further action, such as seizure of the products.
In addition, the U.S. Department of Justice, acting on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Illinois alleging, among other things, that kratom is a new dietary ingredient with inadequate information to provide assurance that it doesn’t present a risk of illness or injury. The FDA is warning consumers not to use any products labeled as containing kratom.
If you have taken a supplement with kratom and have experienced adverse effects, you can report them to the government. Fill out the FDA’s MedWatch Adverse Reporting Event form online, or download the form and fax it to 1-800-FDA-0178.
The FDA is starting to police dietary supplements more vigorously, as many of them have been recalled in recent months for containing unapproved drugs. Last month the FDA created the Office of Dietary Supplement Programs. Unfortunately, the FDA does not regulate dietary supplements unless a problem is reported. The government can also enforce good manufacturing practices.
And last year, the FDA warned the public that the government does not evaluate supplements before they enter the market. Manufacturers are responsible for making sure that the products they sell are safe. But many of these products have ingredients that can interfere with prescription drugs and contain drugs banned because they cause cancer, heart problems, and strokes.
Some states have also targeted dietary supplement manufacturers. Last February, the New York state Attorney General asked several stores, including GNS, Target, Walmart, and Walgreens, to stop selling their store brand, or generic, herbal supplements because they did not contain the plant species identified on the label. In addition, some had contaminants that were not on the label.
Dietary supplements cause about 20% of drug related liver injuries, according to the New York Times, and the FDA has received many reports of adverse events caused by these supplements. About 50,000 adverse reactions to dietary supplements occur every year. Those sold as weight loss products and male enhancement products are the ones most often recalled for unapproved drugs.
