Sept 12 (Reuters) - U.S. Food and Drug Administration

Commissioner Martin Makary said on Friday that Hims & Hers'

Super Bowl advertisement breached federal law as it

highlighted the benefits of weight-loss drugs without mentioning

side effects.

Under federal law, prescription drug ads must present a

"fair balance" of risks and benefits, Makary said in JAMA, a

peer-reviewed medical journal published by the American Medical

Association.

He said the FDA used to issue hundreds of warning letters

annually in the late 1990s compared with just one in 2023 and

none in 2024.

The U.S. is one of only two countries globally that allow

direct-to-consumer (DTC) pharmaceutical advertising, Makary

said.

This follows Donald Trump signing a presidential memorandum

on Tuesday, urging his administration to strengthen enforcement

of DTC pharmaceutical ad regulations to ensure transparency and

accuracy.

On the same day, the FDA said it would issue around 100

cease-and-desist enforcement notices and thousands of warning

letters to pharmaceutical companies, reminding them to adhere to

advertising rules.

Hims & Hers did not immediately respond to a request for

comment. It had aired an ad during the Super Bowl in February

showcasing its compounded versions of Novo Nordisk's

Wegovy.

U.S. regulations permit compounding pharmacies to replicate

brand-name drugs during periods of shortage. Wegovy had seen

significant supply constraints in the country last year.

Americans unable to afford Wegovy or facing difficulties

obtaining it have turned to lower-cost options offered by

pharmacies and telehealth providers such as Hims & Hers and

WeightWatchers.

"Online pharmacies are advertising drugs with only upsides

mentioned, contributing to America's culture of over-reliance on

pharmaceuticals for health," Makary said, adding that the Hims &

Hers ad was the most overt breach of FDA's regulations on

advertising.