In order to compete with medications, more and more marketers of natural products are using phrases like “nature’s Ozempic.” However, comparing supplements to drugs could land companies in hot water.
"Comparing supplements to drugs is a great way to attract FDA attention," explained Asa Waldstein, principal of Supplement Advisory Group. "Over the years, there have been FDA warning letter examples where supplement companies have been cited for making claims like ‘nature's aspirin’ and ‘natural Viagra’ claims."
“In the weight management category, the biggest no-nos are claims for obesity or diabetes. Also, comparing your supplements to drugs intended to treat those diseases—for example a claim like ‘nature’s Ozempic’—will also likely trigger a big fat warning letter,” said Ivan Wasserman, managing partner at Amin Talati Wasserman.
Testimonials
Losing weight takes time and effort, but it often begins with inspiration. And when it comes to shedding pounds, consumers don't have to look far to find "success stories".
"As weight loss advertising tends to be testimonial driven—often with compelling before and after images—it is very important that advertisers understand and follow the FTC’s rules on testimonials and endorsements," cautioned Wasserman. "One area where advertisers tend to get tripped up is that they must have adequate substantiation that the amount of weight the customer claims she lost by taking the supplement is 'typical' of what consumers should generally expect to achieve, and if it is not typical, you must prominently disclose what the typical amount is."
Waldstein added that long gone are the days when companies making outlandish weight loss claims could simply write "results not typical" to protect themselves from enforcement.
"In all marketing, the more quantifiable the claim, such as 'I lost 20 pounds in 10 weeks', the more likely it is to be scrutinized," Waldstein said.
Supplement companies that imply their products work better than drugs can also expect to attract FDA scrutiny.
"Even posting customer testimonials such as 'I've been off my medications and am taking this supplement for a month and feel great' significantly elevates the risk of receiving a warning letter," said Waldstein.
Weighing your options
When companies compare their supplements to drugs, Waldstein explained that FDA likely bases its enforcement action on safety risks related to not taking the referenced medication. For instance, if a company is making a "natural antidepressant" statement, the safety ramifications of someone stopping their medications for a natural alternative could have dire consequences. He added that similarly, if a person forgoes taking Ozempic for a natural product, there’s a potential safety concern related to untreated diabetes care, which would likely attract a warning letter.
"Much of the enforcement related to weight loss claims happens by FTC, and their Gut Check: A Reference Guide for Media on Spotting False Weight Loss Claims document provides examples of types of weight loss claims to avoid," Waldstein said. "Lower risk strategies for making weight loss claims are keeping with general structure function and substantiated statements like 'supports optimal weight management' or 'supports metabolic function', as well as not overpromising weight loss."
FTC and FDA
"Over the last few decades, the FTC, more than the FDA, has been the 800-pound enforcement gorilla in the weight loss category," Wasserman said. "Weight loss related claims have been perhaps the FTC’s biggest target, and it has brought cases against all of the major commercial diet programs like Jenny Craig, Nutrisytem, Weight Watchers, Medifast, etc. as well as weight loss devices like the exercise equipment and electric abdominal belts, and against a ton of dietary supplements, including one of my favorite named products 'Exercise in a Bottle'. The FTC knows losing weight is very hard and that desperate people will always be looking for that 'magic pill'."
Like any health claim, Wasserman said the key to weight management claims is ensuring that you have adequate scientific evidence, which would ideally include one or more double-blind, placebo-controlled clinical studies with statistically and clinically significant differences between groups, and that both the expressed and implied claims in the advertising match the evidence.
"It is important to know that weight loss, inch loss and fat loss are three different claims and that one may imply the other, and that each claim needs to be substantiated," Wasserman explained. "It is also important to know that weight loss claims are different from weight loss maintenance claims (how long you can keep the weight off – which of course is typically the hardest thing). It is also incredibly important that the claims not overstate the amount of weight loss proven by the study, and that if the study participants followed a diet or exercise program, that it does not appear in the labeling or advertising that taking the supplement alone will result in weight loss."
Stay the lane
At the end of the day, Wasserman fears that in order to compete with pharmaceuticals, natural product marketers will feel forced to promise results that may not match the evidence.
“It is akin to anti-aging cosmetics comparing themselves to surgical procedures," he said. "While that tactic may help with short-term sales, it will result in unhappy customers and perhaps enforcement action. My hope is that marketers will be able to tell compelling, science-backed stories on how their supplements, in combination with healthy eating, will help them to safely meet their weight loss goals."