- For Immediate Release:
The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration recently issued joint warning letters to operators of two websites illegally selling Schedule II stimulants, including amphetamine drug products marketed as Adderall. These websites sell Adderall online without a prescription, which places consumers at risk.
Adderall is an FDA-approved prescription drug that has a high potential for abuse and addiction and should only be used under the supervision of a licensed health care professional. This joint action demonstrates the federal government’s ongoing commitment to reduce the public health danger posed by drugs illegally sold online.
“This action underscores the FDA’s commitment to use all available regulatory and compliance tools to stop online businesses illegally selling potentially harmful drug products to consumers,” said FDA Commissioner Robert M. Califf, M.D. “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse and overdose. These particular types of online pharmacies also undermine our efforts to help consumers safely purchase legitimate prescription medicines over the internet. FDA will continue partnering with DEA in an effort to safeguard public health and protect consumers who need access to these important medicines.”
Illegally marketed prescription drugs pose significant risks to consumers who purchase those products. Consumers who buy prescription drugs from unsafe online pharmacies may put their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise harmful.
The warning letters were issued to:
Consumers should dispose of unused medicine from these websites and not purchase or use prescription drugs sold from these websites without a prescription. The FDA urges consumers to obtain prescription drugs from state-licensed U.S. pharmacies or physicians located in the United States, where the FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution, and labeling.
“These letters are not only a warning to the companies that illegally sell prescription medications, but they also serve as a warning to consumers who have bought or have considered buying medications online without a legitimate prescription,” said DEA Administrator Anne Milgram. “Consumers cannot trust the safety or legitimacy of pills sold on unaccredited sites. DEA strongly urges anyone seeking controlled medications to obtain a prescription from a trusted medical professional and have it dispensed by a licensed pharmacy. We will continue working closely with our FDA partners to protect the integrity of the prescription drug supply chain and ensure the safety and health of our communities.”
As noted in the warning letters, these websites sell amphetamine drug products, including Adderall, that are misbranded in violation of the Federal Food, Drug, and Cosmetic Act. The website operators also violate the Ryan Haight Online Pharmacy Act (RHA) by failing to register their online pharmacies with the DEA despite knowingly or intentionally advertising the sale of controlled substances. The RHA has, among other provisions, requirements that must be met for controlled substances to be legally distributed and dispensed via the internet. For example, an entity must be registered with the DEA to specifically dispense controlled substances; none of these are currently registered with the DEA to dispense or distribute controlled substances online.
The online operators will have 15 business days to respond to the agencies with specific steps taken or steps they will take to address any violations and to prevent their recurrence.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Lauren-Jei McCarthy
- (240) 702-3940