FDA Blocking ‘Fraudulent’ Covid Products
FDA says it is refusing entry into the U.S. of fraudulent Covid-19 products or substandard products when it discovers them. The statement came to FDA Webview after our request for comment on a story indicating that the agency has increased its seizure of prescription drugs mailed to American customers from pharmacies in Canada and other countries.
FDA press officer Jeremy Kahn e-mailed us that the agency “is thoroughly examining mail parcels referred by Customs and Border Protection at the international mail facilities. This is a high priority for the agency especially in light of the current pandemic environment.”
Kahn noted that the agency can’t ensure the safety and effectiveness of medicine purchased over the Internet from foreign sources, storefront businesses that offer to buy foreign medicines for Americans, or during trips outside the U.S. The original article for which FDA Webview sought comment described the experiences of a consumer who purchased prescription drugs through Canadian MedStore, a Florida storefront business that facilitates purchases from a Canadian pharmacy.
According to the FDA response, medicines purchased online from foreign sources “may present risks to American patients as they could be contaminated, counterfeit, contain varying amounts of active ingredients or none at all, and/or contain different ingredients than the FDA-approved product.” It also said the imported products could have directions for use that could be misleading or inaccurate, the recommended dosage may be harmful to the consumer, or the Contraindications section of the labeling may not contain all of the products a user should avoid when taking the medication, leading to serious injury, illness, or even death. “For these reasons,” Kahn wrote, “FDA recommends only obtaining medicines from legal sources in the U.S.”
The response did not address the fact noted in the original story that the increase in mail facility seizures comes at a time when the Trump administration is working with Florida, Colorado, and other states on a system to help more Americans import drugs from Canada. It also did not address the fact reported in the original story that since 2003 FDA has not stopped Florida retail stores from helping Americans import drugs from abroad. Although the agency raided nine storefronts in 2017, the story said, it allowed them to continue operating.