The FDA warns manufacturers of drugs as losing weight to remove “false and misleading” advertising

The Food and Drug Administration published more than 100 letters on Tuesday to various drug manufacturers and online prescription companies, including Hims & Hers, which has built a company of several billion dollars centered on lower cost versions of successful obesity injections.

The FDA warned the company to delete the “false and deceptive” promotional statements from its website, including the language saying that its personalized products contain “the same active ingredient” as the drugs approved by the FDA Wegovy and Ozempic. The formulations cited by regulators are produced by specialty composition pharmacies and are not examined by the FDA.

“Your statements imply that your products are the same as a product approved by the FDA when they are not,” said the warning letter, dated September 9.

Hims said on Tuesday that he is looking forward to getting involved with the FDA “.

“Our website and our customer -oriented materials note that compound treatments are not approved or evaluated by the FDA,” the company said in a press release.

This is the first attempt by the police FDA directly online platforms like Hims, which have long argued that they are not subject to the traditional rules of drug advertising.

The FDA also published distinct warning letters to the manufacturers of so-called GLP-1 drugs, contesting an infopublicity in 2024 with Oprah Winfrey. The regulators said that the 42 -minute television segment of Eli Lilly and Novo Nordisk gave a “misleading impression” on the safety of Zepbound, Wegovy and “similar drugs with multiple serious and potentially potential risk”.

Washington meticulous examination

The Secretary of Health, Robert F. Kennedy Jr., has long criticized the pharmaceutical industry, including GLP-1 drugs, and the previously suggested Americans can reverse obesity with diet and exercise alone.

A service note signed by President Donald Trump last week ordered Kennedy and the FDA to ensure that pharmaceutical advertisements on television, social media and other websites are “truthful and not linked to the fact”.

The new FDA letters each contain the language “to stop and abstain”. It is a different approach to the agency, which generally writes its letters in a highly bureaucratic language citing specific regulations of the FDA.

Hims has been under the control of Washington for some time.

Earlier this year, an announcement of the company’s Super Bowl presented the advantages of its weight loss drugs, but has not listed any of their side effects or their potential damages. FDA rules require advertisements to have a balanced image of risks and benefits for drugs.

Makary distinguished the announcement in the newspaper of the American Medical Medical Association of last week, calling it as “cheeky” example of the way in which advertising “contributes to renowned American culture on pharmaceutical products for health”.

HIMS and similar companies initially sold inexpensive generic versions of hair loss, erectile dysfunction and other health problems. But the booming demand for obesity drugs opened the door to the sale of cheaper copies.

The FDA allows so -called composition or personalized production when there is a shortage of official versions of drugs approved by the FDA.

The FDA recently determined that GLP-1 drugs no longer met the shortage criteria. This should have ended the composition, but there is an exception: practice is always authorized when a prescription is personalized for the patient.

HIMS and other companies have decided to offer doses and “personalized” formulations for certain patients, arguing that they offer additional advantages.

The actions of Hims & Hers Health Inc., based in San Francisco, fell by more than 6.47% in trade on Tuesday.

The letters published on Tuesday come from the FDA pharmacy center.

A letter published last week from the FDA vaccine division led a television advertisement for the vague vaccine of Astrazeneca, saying that the “background music and visual distractions” of the spot harm information on side effects. The letter was signed by the FDA vaccine chief, Dr. Vinay Prasad, an ally of Kennedy who recently returned to his job at the agency after being briefly forced to withdraw.

Researchers and consumer defenders have been complaining for a long time that optimistic television images of patients enjoying life with family and friends often eclipses discussions on side effects.

In addition, studies have shown that patients exposed to drug advertisements are more likely to ask their doctors about the medicine, even if they do not meet the prescription criteria. The American Medical Association, the largest group of doctors in the country, appeared to support a ban in 2015, citing the role of television advertising in “the demand for the demand for new and more expensive drugs”.

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