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The agency points out the compounded drugs are not the same as FDA-approved drugs

By Mark Huffman of ConsumerAffairs

• The FDA has issued 30 warning letters to telehealth companies over misleading claims about compounded GLP-1 drugs.

• Regulators say some companies implied their compounded products were equivalent to FDA-approved medications or obscured where the drugs were made.

• The action is part of a broader crackdown on misleading direct-to-consumer pharmaceutical advertising launched last September.

The U.S. Food and Drug Administration (FDA) has issued warning letters to 30 telehealth companies for making false or misleading claims about compounded GLP-1 drugs promoted on their websites.

The agency said the companies marketed compounded versions of GLP-1 medications in ways that suggested the products were the same as FDA-approved drugs or failed to clearly disclose where the medications were produced.

Its a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platformsand taking swift action, said FDA Commissioner Dr. Marty Makary.

Dr. Makary said compounded drugs can play an important role in addressing shortages or meeting specific patient needs, but warned that compounders should not attempt to bypass the FDAs drug approval process.

Second wave of actions

The warning letters mark the second wave of enforcement actions targeting telehealth companies since the FDA launched a broader effort last September to police misleading direct-to-consumer pharmaceutical advertising.

Over the past six months, the agency said it has sent thousands of warning letters to pharmaceutical and telehealth companies directing them to remove misleading advertisements more than were sent during the entire previous decade.

According to the FDA, the most common violations involved claims that compounded GLP-1 products were the same as FDA-approved medications. Other companies promoted drugs using their own brand names or trademarks without clarifying that a separate pharmacy actually compounded the medications.

The FDA emphasized that compounded drugs are not FDA-approved, meaning the agency does not review them for safety, effectiveness,or quality before they are sold. The agency also noted that compounded drugs are not equivalent to generic drugs, which must undergo FDA review and approval.

The warning letters require the companies to correct the violations and remove misleading claims from their marketing materials. Failure to comply could result in further regulatory action, the agency said.