FTC Warnings: Should Supplement Sellers Be Worried?
By Richard Parkin
Right now, more people are using supplements than ever before, with the CDC estimating that well over half of all Americans have used some kind of supplement in the last 30 days alone. While this environment offers supplement sellers a previously unimaginable opportunity for success, it’s also attracting a seemingly increasing level of legal scrutiny.
Recently, the FTC released a major press release, including details of 10 cease and desist letters they (along with the FDA) issued to sellers of ‘treatments’ for diabetes. While it’s hardly uncommon for the FTC to put out press releases, this one caught people’s attention for two reasons: the scale of the release, and the exact actions taken.
Typically, FTC press releases cover one company, or a small number of collected companies – look at the other company-related releases in September: “FTC Sends Refund Checks to People Harmed by Abusive Debt Collector”; “FTC Fines Capital One CEO Richard Fairbank for Repeatedly Violating Antitrust Laws”; “FTC Bans SpyFone and CEO from Surveillance Business and Orders Company to Delete All Secretly Stolen Data” – all limited in scope.
In contrast, this release explicitly targets 10 entirely unconnected companies, ultimately giving other non-compliant businesses a clear warning – fix the problem, or risk serious prosecution. Here’s what supplement marketers need to know:
Understanding FTC Regulation for Supplements
As the FTC’s Acting Director points out near the beginning of the press release, with rising prices and supply shortages, people are increasingly turning towards cheaper “questionable products” rather than proven drugs, particularly when those alternatives claim to offer miracle cures, or ways to mitigate the damage caused by illnesses and diseases.
In the release, the FTC includes links to the 10 warning letters they issued. While the specific details vary between companies, most of the businesses in question made false or unsupported medical claims about their products, while either explicitly or implicitly promoting their products as a way to cure or minimize the effects of diabetes, leading to the FTC issuing their cease and desist letters.
This isn’t new guidance or regulation – if anything, the FTC is just getting stricter about enforcing the law in response to increasing demand for less expensive medicinal options, aiming to protect consumers from supplements claiming to offer unsubstantiated health benefits.
Consider the FDA’s exact definition of a drug: an item “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”. Simply calling a product a ‘supplement’ does not change the regulation here – if you’re selling a supplement that claims to cure, prevent, or treat diabetes (or any other condition), it is a drug.
Given this increased attention, it’s now more important than ever for supplement marketers to market their services in an accurate, compliant way, or face company-jeopardizing prosecution.
FTC & FDA Compliance for Supplements
To ensure compliance for any supplements you sell, it’s usually worth going back to the beginning with the combined guidance issued by the FTC and FDA.
The FTC explicitly points out that whenever a ‘health claim’ is made, marketers should provide “strong scientific support and careful presentation” to back it up. While many of the businesses targeted by the FTC’s warning letters made explicit health claims (“Helps control diabetes”; “decrease your body’s need for insulin”; “May help balance Blood Sugar Levels”), any implicit claims also require full substantiation.
Substantiation isn’t just about finding a single, small survey that suggests that an ingredient may result in a certain kind of effect – it typically requires high-quality, peer-reviewed studies showing and explaining that effect.
The studies also need to be relevant to your product – it doesn’t matter that you’ve collected 20 world-class studies demonstrating that taking 50 mg of Ingredient X daily reduces blood sugar if your product only contains 25 mg of that ingredient.
It’s also worth considering the role your customers play in marketing your products, one of the least immediately obvious regulations for marketers. An honest review can be an incredible marketing tool – but if you’re selling supplements, any reviews you quote need to reflect the average user’s experience.
In other words, you can’t cherry-pick the best reviews you’ve ever had, you need to pick average reviews. Of course, it’s often impossible to determine exactly what the ‘average user experience’ is, and to find a review reflecting that, making reviews a potentially dangerous area for compliance when marketing supplements of any kind.
If you are promoting a supplement, you’re likely making health claims of some kind. Now’s the time to review your advertising – do you really have enough evidence to support the claims you’re making?