The U.S. Food and Drug Administration (FDA) announced today that it “is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.” The FDA’s announcement comes just days after the agency issued Warning Letters to 15 foreign and domestic companies who sell alternative treatments for diabetes.
What action is FDA taking?
The FDA has issued warning letters against 24 products “claiming to treat, cure, prevent, or mitigate diabetes and related complications (e.g., blindness, nerve damage, kidney failure, heart disease, lower-extremity amputations, etc.).”
The products targeted include dietary supplements, over-the-counter drugs (OTC), homeopathic drugs, ayurvedic, cosmetics, as well as unapproved versions of prescription diabetes medicines. The FDA reports to have found products containing the active pharmaceutical ingredients (API) metformin, phenformin, and/or glyburide, marketed without an approved new drug application (ANDA), in violation of the Food, Drug and Cosmetics Act (FDCA).
In the press release, the FDA expresses concern over the possibility that persons inflicted with diabetes may forego medical treatments by their licensed physicians, to try a “natural” or alternative “equivalent”. The FDA states:
Many of the illegally sold products that are the subject to this action include claims such as “prevents and treats diabetes,” and “can replace medicine in the treatment of diabetes.” In addition, some of the products may cause harm because the products contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.
These illegally sold products include:
· Products sold as “natural” treatments for diabetes, but containing undeclared active pharmaceutical ingredients in unknown quantities that could cause harm or complicate medical conditions;
· Dietary supplements and ayurvedic products (medicine of the healing arts that originated in India) with claims to treat, cure, and/or prevent diabetes;
· Unapproved drugs sold over-the-counter, including some homeopathic products, intended to treat complications associated with diabetes, which include relieving symptoms caused by nerve damage in the arms and legs (also called peripheral neuropathy); and
· Prescription drugs for diabetes sold by online pharmacies without a prescription.
What is an FDA Warning Letter?
Warning Letters are utilized by the FDA as the primary manner of notifying regulated industry that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), or related regulations and policies.
The FDA’s position is that Warning Letters are issued only for “violations of regulatory significance” — violations that may lead to enforcement action if not promptly and adequately corrected.
The use of Warning Letters and the prior notice policy are based on the expectation that most members of regulated industry will voluntarily comply with the law upon receipt of a Warning Letter. Thus, they are the FDA’s principal means of achieving prompt voluntary compliance with the statutes, regulations and policies the Agency enforces.
When representing clients who have received a Warning Letter, we first calculate and calendar the deadline to respond to the FDA’s allegations. All Warning Letters provide a limited timeframe, usually fifteen (15) working days, for the recipient to respond. This is a critical opportunity that must not be overlooked, as a failure to respond may result in further enforcement action.
Responses to Warning Letters should specifically address the subject violations and the steps the firm is taking, or will take, to correct the violations. When preparing responses on behalf of our clients, we first work with the recipient to develop a detailed corrective action plan (CAP) that not only addresses the noted violations, but also the underlying issues that caused the deviation. Since the FDA regularly conducts follow up inspections to verify that corrective actions have actually been implemented, it is important for firms to take a closer look at all of their products, practices and processes. It is not unusual for the FDA inspector to note other significant violations during a follow up inspection. Failure to achieve compliance during a follow up inspections could lead to further FDA action including seizure of misbranded products, suspension of a food facility registration number, or placement on Import Alert, among others.
Once we have identifying the underlying issues, we work with clients on drafting a viable CAP that includes immediate corrective measures, as well as short-term and long-term goals. Attaching a comprehensive CAP to the response letter is a surefire way of reassuring the FDA that the company has heeded the “warning”.
As stated above, failure to timely respond to a Warning Letter can result in immediate enforcement action, without additional notice. In the Warning Letters issued in this latest action against diabetes treatments, the FDA has warned that “[c]ompanies that fail to respond to the warning letters or make adequate corrections could be subject to further actions, including seizure, injunction, and criminal prosecution.”
Additionally, whenever a recipient disagrees with the FDA, does not understand the violations, or believes the Warning Letter was issued erroneously, an opportunity to meet with district officials or center officials should be immediately requested. It is not prudent to disregard any Warning Letter from the FDA, as doing so can have serious business consequences.