By Jeffrey A. Newman Esq.
The Food and Drug Administration has announced that it is restricting the sale of GLP-1 non approved ingredients that are made and sold by compound pharmacies. These products are being mass-marketed as similar alternatives to approved FDA drugs. The FDA is also taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025. In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.
The FDA said that it will use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns. Entities engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed. FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In some cases, the compounding pharmacies identified on the labels of the products do not exist. In other cases, the labels of the fraudulent compounded medicine contain the name of a licensed pharmacy that, based on information FDA has gathered, did not compound these products.
According to medical articles, the major dangers of Compounded GLP-1s are :
Lack of Medical Supervision: Many compounded GLP-1s are obtained via online telehealth, which may bypass the necessary, close medical monitoring required for managing these potent drugs
Dosing Errors & High Potency: Compounded products often require manual measurement from vials, leading to errors. Some formulations have resulted in severe hypoglycemia (low blood sugar), severe nausea, and vomiting due to incorrect, sometimes dangerously high doses.
Contamination and Impurities: Compounding pharmacies may not adhere to the same rigorous sterile manufacturing standards as pharmaceutical companies. Studies have shown unknown impurities up to 33% in tested, non-FDA-approved semaglutide products.
Unapproved Ingredients: Some pharmacies are using “salt forms” of semaglutide (such as semaglutide sodium or acetate), which are not the same as the active ingredient in FDA-approved Wegovy or Ozempic and have not been proven safe or effective.
Serious Adverse Events: Reports indicate higher rates of adverse effects, including gallbladder issues, severe gastrointestinal pain, and, in some cases, hospitalization.
Jeffrey Newman, JD MBA, is a whistleblower lawyer whose firm represents healthcare fraud whistleblowers and whistleblowers reporting violations of export controls, tariff evasions, money laundering, and other kinds of WB cases. Mr. Newman and his staff also represent many physician whistleblowers in healthcare fraud cases. Whistleblower laws in the U.S. allow individuals anywhere with information about export control violations or tariff fraud to reveal the information under The False Claims act . The Firm’s website is www.JeffNewmanLaw.com. Attorney Newman can be reached at Jeff@Jeffnewmanlaw.com or at 978-880-4758. FOR OTHER ARTICLES LIKE THIS and WHISTLEBLOWER INFO PLEASE SEE http://JeffNewmanLaw.com
