Weight-loss drug giants face sternest test yet | Official Website of Louis Velazquez, entrepreneur, finance guy and tech innovator

The weight-loss drug boom has, in many ways, turned into a generational market story.

For perspective, the U.S. obesity crisis touches 40% of adults, and weight-loss drug sales could top a whopping $100 billion by 2030 as GLP-1 use expands across diabetes into chronic weight management.

At the center of it are Big Pharma plays such as Eli Lilly’s (LLY) Zepbound/Mounjaro and Novo Nordisk’s (NVO) Wegovy/Ozempic brands that continue to add billions in equity value since 2023.

Meanwhile, telehealth giants such as Hims & Hers (HIMS) have aimed at GLP-1 programs that widen access and intensify competition on pricing, convenience, and follow-up care.

However, a massive new test has arrived after a few years of breakneck expansion and rising expectations.

Surprisingly, it’s less about the science and more about how this category speaks to consumers, and how quickly businesses can adapt when the rules of the game are flipped.

An FDA crackdown puts weight-loss drugs on notice.

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Regulators crack down on weight-loss drug marketing claims

Eli Lilly, Novo Nordisk, and Hims & Hers have just been handed formal warning letters from U.S. regulators, and the issue isn’t their science; it’s their advertising.

The Food and Drug Administration (FDA) flagged key interviews and marketing materials that say these companies either downplayed safety risks or exaggerated the benefits.

For investors, it’s a powerful reminder that the fast-growing obesity-drug market is firmly in Washington’s crosshairs.

Regulators cited a 2024 Oprah Winfrey special in particular, where Lilly and Novo representatives discussed drugs like Zepbound, Mounjaro, Wegovy, and Ozempic, but apparently did not give equal weight to boxed warnings and serious side effects.

Hims & Hers was called out specifically for misleading claims over compounded semaglutide, the active ingredient in Wegovy and Ozempic.

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Moreover, the crackdown is linked directly to President Donald Trump’s executive order, which requires greater disclosure in drug ads.

FDA Commissioner Marty Makary said that nearly 100 cease-and-desist notices will follow, easily making it the most aggressive advertising enforcement in years. These businesses have 15 business days to respond or face stern legal action.

Weight-loss drugmakers have had multiple setbacks

Weight-loss drugmakers have run into a ton of trouble over the past couple of years. Safety flags, counterfeits, and supply strain have slowed down the pace of expansion for the biggest names in the niche.

Noteworthy setbacks among weight-loss drugmakers so far

Sep 2023: FDA adds an ileus warning (bowel blockage) to Ozempic’s label, underscoring the GI risks related to the drug.
Jun 2024: WHO alert cautions on falsified Ozempic detected in the UK, U.S., and Brazil.
Apr 2025: FDA warns of counterfeit Ozempic in the U.S. drug supply chain.
Feb 2025: FDA declares semaglutide injection shortages resolved after a year-long crunch.

The prolonged manufacturing bottleneck had many of the stalwarts scrambling for new ways to bridge the demand/supply gap. Novo, for instance, closed a $16.5 billion Catalent acquisition in bolstering fill-finish capacity, while patients turned to compounded copies during the shortage.

Moreover, even with supply normalizing, coverage remains uneven. The larger employers cover over 50% of their members, while smaller groups are doing far less, and affordability worries persist.

Additionally, the biggest near-term risk for weight-loss drugmakers isn’t about demand but operations.

Manufacturing of GLP-1s is still weighed down by peptide synthesis, sterile fill-finish, and pen-device assembly. On top of that, cold-chain logistics and counterfeit copycats add to that strain.

Another major pressure point is payer economics. Coverage varies widely, with employers looking to test carve-outs and caps.

Also, there are a ton of competition, challenges, and policy looms, along with intellectual property battles, and international price controls potentially eating into margins and exclusivity.