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, advertisements for prescription drugs

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 also highlighted a sharp drop in FDA enforcement, saying

the agency used to issue hundreds of warning letters annually in

the late 1990s compared with just one in 2023 and none in 2024.

A Hims & Hers spokesperson said the company's "Super Bowl ad

did not advertise any one treatment or solution."

"Rather, it aimed to raise awareness to a critical issue -

the obesity public health crisis - by showcasing the impact of

obesity and the realities of the lack of access to life-saving

holistic weight loss care," the spokesperson said in an emailed

statement.

The FDA's latest move follows a presidential memorandum

signed by Donald Trump on Tuesday, urging his administration to

step up enforcement of direct-to-consumer (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

DTC advertising rules.

Makary noted that the U.S. is one of only two countries

globally that allow DTC pharmaceutical advertising.

Hims & Hers 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.