Pain Claims: Navigating pain-relief supplement claims

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In a vast health products marketplace with many competitors, product claims have great value and can make all the difference in product sales. But dietary supplement manufacturers need to tread lightly when making express or even implied health claims. If health claims aren’t adequately substantiated, history shows that warning letters and lawsuits are a likely risk.

How should supplement manufacturers and marketers handle the subject of pain relief? It’s a common concern among consumers. Many of the ingredients used in today’s health product formulas have been associated with reduction in self-reported pain and related biomarkers in published research. But is that enough?

In recent months, even products featuring ingredients as common as magnesium sulfate and glucosamine have been the focus of class action lawsuits. So, what’s the safest way to navigate pain-relief health claims in a well-policed industry, and how can brands substantiate their claims?

Jurisdiction

While a disgruntled consumer or overzealous litigator may be the first person to notice a pain-relief claim that could be called into question, the official power to make judgements comes down to FDA and FTC. Though FDA controls the advertising and labeling of foods, drugs, medical devices, and cosmetics, every pain claim doesn’t require FDA approval. It’s ultimately up to FTC to assess the truth or falsity of all advertising.

“Independent of FDA regulations, advertising claims must be truthful under the FTC Act,” says Laura Brett, vice president of the National Advertising Division at BBB National Programs (McLean, VA), an independent nonprofit organization that evaluates all forms of advertising. “In other words, whether a product is making a claim that complies with FDA regulations is a separate question from whether it is making a claim that is truthful and substantiated.”

“Moreover,” she says, “there are other attributes related to the nature of a product’s pain relief that may not be covered by its FDA regulatory scheme, which companies may tout to consumers.” Two examples are onset of action (how quickly a product provides relief) and duration (how long the pain relief lasts).

Substantiation

For any pain-relief claims, ranging from general pain relief to the duration of pain relief, scientific substantiation is required to the extent that experts in the field believe is reasonable, says Brett. Generally speaking, the gold standard for substantiation would be double-blind, randomized, placebo-controlled human clinical testing that demonstrates the product’s effect on pain. Fail to do this or present evidence of such testing on an identical product, and you may run the risk of misbehavior.

But a gold standard test isn’t the only way to establish a reasonable basis for a claim.

“If you have less evidence, a prominent disclosure about the amount of evidence you possess for a claim could help set reasonable expectations about the product,” says John E. Villafranco, partner at Kelley Drye & Warren LLP, a law firm with significant expertise in the dietary supplement industry.

The more precise a brand can make its research and messaging to consumers, the better.

Messaging

How pain relief is conveyed is not as important as the content of the message. Whether a claim is expressly stated on a product label or website, or implied through pictures, video, and customer testimonials, Brett says that if the consumer takes away a message that the product relieves pain, the brand must comply with FTC’s standards for scientific substantiation.

Apart from avoiding any suggestion that a product diagnoses, cures, mitigates, treats, or prevents a disease (“prevents arthritis pain”) or its characteristic symptoms (“joint-pain relief”)—all of which qualify as disease claims—it’s most important that brands stick to specific claims that they can substantiate.

“And when you do have substantiation, make sure you don’t say more than you can show,” says Villafranco. “For example, if your study shows your product reduced soreness, stick with that rather than stating your product eliminates it.” Soreness, aches, and sunburn are specific kinds of pain that, if well substantiated, make brand messaging less open to interpretation and accusation.

Again, all marketers of ingredients and finished products must consider the consequences of a false claim and create their brand messaging appropriately.