Robins took action by seeking class-action status for customers who were also impacted by the practices.
The class action complaint pointed to a lack of “clinical data that supports the notion that simply boosting the amount of naturally occurring GLP-1 in the body has sustained weight-loss effects.”
In the era of GLP-1 agonist medications, what can supplement companies say about products that claim to support the drugs? What are red flags when it comes to oversight? And where might gray areas exist?
The FDA and Amazon
Lemme is not the only company with weight management claims in question. The weight management sector has faced problems for years with its assertions regarding the benefits of supplementation. So much so that Amazon listed the sector as one of three initial categories for its third-party testing, inspection and certification services program, which monitors for supplement safety and the accuracy of product labels.
Weight management supplements are flagged because of a history of banned and undeclared ingredients, safety concerns and companies making unauthorized health claims.
“Companies should expect extra scrutiny for any weight loss support claims,” said Asa Waldstein, principal at Supplement Advisory Group. “Ensuring the substantiation dossier is solid is essential.”
Organizations selling weight management supplements must comply with policies dictated by the federal government and corporations like Amazon which require a thorough understanding of what claims can be made. The U.S. Food and Drug Administration considers obesity to be a chronic disease, which impacts how it regulates those claims.
According to Waldstein, companies should exercise caution to avoid promising drastic weight loss benefits. The U.S. Federal Trade Commission closely monitors this practice, including the use of before and after pictures. The FTC’s Gut Check also outlines what companies should not do. The commission says selling products that claim to cause weight loss of two pounds or more a week for more than a month without dieting or exercising is prohibited. Another false claim is stating a product blocks the absorption of fat or calories to enable consumers to lose substantial weight.
What can supplement companies say about their products? Waldstein lists seven possible areas where claims can be made:
• Promotes satiety and lessens “food noise”
• Supports energy
• Supports balanced blood sugar levels already within normal range
• Supports cognition and mood
• Helps support a person’s weight loss journey
• Helps an individual feel their best
• Supports muscle mass integrity
Supporting the GLP-1 journey
Since the influx of weight-loss-inducing GLP-1 agonist medications (think brands like Ozempic, Wegovy and Mounjaro), supplement companies have rolled out products to support consumers on their health journeys, marketing supplements like fiber, probiotics and herbal extracts to combat the side effects of GLP-1s. These supplements claim to boost nutrient levels, promote skin health, mitigate the impact of muscle loss due to the medications and offer gastrointestinal support as the drugs can sometimes cause stomach upset.
Supplement giants like The Vitamin Shoppe and GNC saw opportunities early on in the GLP-1 era. GNC was the first major retailer to launch a GLP-1 support program, while The Vitamin Shoppe went further and launched a platform that combined telehealth services along with GLP-1 support.
GNC also ran a study of participants on GLP-1s and found they were not meeting their dietary reference intakes, as calorie and protein consumption appeared suboptimal when they were on the weight loss medications.
Waldstein said that because GLP-1 is a natural body hormone, making claims about side effect management is not ultra-high risk. The risk occurs when companies try to address specific symptoms, claiming their supplements help with ‘chronic diarrhea’ or ‘insulin’ or by saying the supplement is nature’s Ozempic.
“Lawsuit risk increases exponentially when ‘clinically proven’ types of claims are made, especially on labels,” he said.
A warning letter
Claudia Lewis, partner at Venable, said the law firm continues to see demand letters and litigation concerns regarding the efficacy and regulatory status of weight-loss supplements and other products, including the ongoing Lemme lawsuit.
The plaintiff in the Lemme case argues that the drugs work by mimicking GLP-1 but with a half-life that is far greater than a supplement—hours or days long, depending on the drug.
“[The Lemme] supplement is advertised to work by increasing the amount of GLP-1 in the body,” said Lewis, who co-chairs her firm’s FDA group. “However, the plaintiff alleges that merely increasing the amount of GLP-1 in the body does not help achieve weight loss, because GLP-1 has such a short half-life at only about two minutes.”
Despite ongoing litigation, Waldstein noted that only one company to date has received an FDA warning letter for making false and misleading claims related to semaglutide, comparing its GLP-1 support supplement to the drug.
The FDA noted that Veronvy, a company that claims its products assist in weight loss and metabolism-boosting, said people on one of its products “not only lost weight” but “also kept it off.”
In addition to a reduced-calorie diet and increased physical activity, Veronvy said its metabolic boost drops “successfully helped people lose up to 52 pounds in three months during clinical trials and was approved by the Food and Drug Administration last year.”
The FDA said Veronvy’s products are “intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body” and categorized these supplements as unapproved drugs.
As GLP-1 is a hormone found naturally in the body, it is not solely associated with a disease. Consequently, GLP-1 can be explicitly referenced and used as part of a structure/function claim.
However, products promising to replace or serve as an alternative to or enhance the efficacy or safety of approved GLP-1 drugs would be unlawful.
According to Lewis, there is an influx of litigation alleging that weight-loss supplements are “unapproved new drugs” because of express or implied references to the treatment or prevention of obesity. In the GLP-1 support supplement context, these references can come up if a company’s advertising compares the product to GLP-1 agonist drugs or their benefits.
“The limitation is that GLP-1 drugs as approved by FDA are intended to treat obesity and diabetes,” Lewis said. “Both are disease states. Claims that suggest that a supplement product can treat those conditions would cause such products to be regulated as unapproved new drugs. “
Scientific evidence
Even if a supplement company has “correct” language in place for a GLP-1 support product, Lewis said the final question is, “does scientific evidence support the claim?”
Weight loss claims can be attractive targets not only for federal but state regulators, too. To minimize the risk of litigation or enforcement action, Lewis said it is important to ensure that all weight loss and other health claims are supported by competent and reliable scientific evidence, or CARSE.
CARSE comprises randomized, placebo-controlled clinical studies on representative populations, using ingredients in the same quantities as consumers will be instructed to take per serving. Scientific results should match the claims made and be both statistically and clinically significant.
“It really depends on the claim being made,” Lewis said. “There are a number of ingredients that have good substantiation in support but in some instances, there is room for debate.”
She added that she expects the litigation trend to continue, especially as additional non-injectable forms of GLP-1 agonist drugs are approved and become available in the market.
