Health Claims Substantiation for Risk-Free Innovation

Health Claims Substantiation for Risk-Free Innovation

Denis Storey
March 2, 2021

On-Demand Webinar: “Health Claims Substantiation for Risk-Free Supplements Innovation”

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On-Demand Webinar: “Health Claims Substantiation for Risk-Free Supplements Innovation”

Watch this webinar with Council for Responsible Nutrition (CRN) President and CEO Steve Mister and TraceGains CEO Gary Nowacki to learn how dietary supplements and natural products companies can ease the burden of health claims substantiation, achieve faster new product development, and connect teams with a networked platform.

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Dietary supplements and natural food manufacturers are well aware of how much work goes into product labels – and how much trouble awaits them if they get it wrong. But what many companies don’t fully grasp is how regulators view – and react to – online marketing.

Regulators treat dietary supplements labeling differently than advertising. The U.S. Food and Drug Administration (FDA) primarily focuses on labeling, while the Federal Trade Commission (FTC) focuses on advertising. But, as Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN), points out, labeling goes beyond just the label.

According to the FDA, labeling includes all written, printed, or graphic material that accompanies the product at any time in the production, sales, and marketing process.

“But the big question in the Internet age is: What do we do about all the claims that show up on a website that can incentivize people to click through and buy a product?” Mister asked.

The Internet remains a minefield for dietary supplements companies because both the FDA and the FTC lay claim to everything online, Mister points out, including social media. The FDA would say, in most cases, online claims are “labeling” while the FTC insists that they’re “advertising.”

According to the FDA, there are four kinds of claims that are allowed and one that’s not.

Nutrient Claims

Nutrient claims are those that characterize the level of a nutrient in a food or dietary supplement, and they’re permissible as long as companies follow the requirements outlined in the existing regulations.

Nutrient content claims refer to both food and dietary supplements and predate the Dietary Supplement Health and Education Act (DSHEA) and were authorized originally by the Nutrition Labeling and Education Act (NLEA) in 1990.

“These products don’t require these kinds of claims to have any premarket review or FDA notification,” Mister explained. “But you do have to follow those regulations. And, in some cases, there are specific requirements. For instance, if you say your product is a good source of protein or is high in vitamin C, there are specific requirements as to the amount of the ingredient per serving that must be in those products.”

Nutrient Deficiency Claims

The next area often gets pushed into nutrient claims, Mister said, but it’s a separate nutrient deficiency category. These include statements that claim a benefit related to a classic nutrient deficiency disease.

“Think about something like vitamin C and scurvy or vitamin D and rickets,” Mister said.

Companies can make a claim for a dietary supplement with relation to one of these kinds of diseases because they’re directly related to nutritional status. But the law requires that if companies make one of these claims, they have to disclose the disease’s prevalence in the claim. But conditions such as scurvy, rickets, and other nutrient-deficient afflictions, are rare in the United States.

“So, it’s a primitive area to explore,” Mister suggested. “It’s the one case where you can talk about a disease, but because of the requirement that you have to disclose that they’re very uncommon, it’s rarely used on supplements packaging in the United States.”

Structure/Function Claims

The third type of claim the FDA allows, and one consumers are most interested in, are structure/function claims. These claims describe the role of a nutrient or a dietary ingredient that’s designed to affect the structure or function of the human body.

It might characterize some documented mechanism of how the nutrient works or describe general well-being that results from the intake of a product. These are permissible claims and make up the vast majority of what’s in the dietary supplements space.

“If you make a structure/function claim, you have to notify the FDA,” Mister said. “That doesn’t mean they get a premarket review. But you have to tell them within 30 days that you’re making that claim. And secondly, if you use a structure/function claim on your label, you must tell the consumer that the FDA hasn’t evaluated that statement.”

Mister added that the FDA won’t necessarily respond to that 30-day notification. But that silence doesn’t translate into consent. 

“The only time companies will hear from the agency is if they send in something that isn’t a structure/function claim, and the FDA decides it’s a disease claim,” Mister said. “In those cases, you’ll get a letter back from the FDA saying this isn’t a legitimate structure/function claim.”

But what is a disease claim? To answer that question, companies have to figure out what the FDA considers a disease. As elementary as that sounds, that question stirs a lot of consternation in the dietary supplements space.

“For instance, the FDA has been clear that menopause isn’t a disease; it’s a life stage,” Mister said. “So, if you have substantiation for the claim, you can make claims around menopause. However, regulators have said that an enlarged prostate is a disease. The FDA doesn’t like structure/function claims that reference benign prostate enlargement.”

Health Claims

Health claims remain a source of confusion in the industry. A health claim states that the food component or dietary ingredient might reduce the risk of a disease or some other health-related condition. And like nutrient content claims, these predate DSHEA.

“These claims don’t promise disease prevention, but rather reducing the incidence of it,” Mister said. “Unlike other permissible claims, this requires the FDA’s approval in advance. A health claim must have a high level of support before you can make it. It requires the significant scientific agreement of qualified experts in the field, and it’s a high standard to meet. It’s hard to get significant agreement among scientists. As a result, few claims have that level of support. One example would be adequate calcium throughout life as part of a well-balanced diet, which might reduce the risk of osteoporosis.”

Qualified Health Claims

That high standard led to the industry’s embrace of qualified health claims, which allow companies to make a claim that includes specific qualifications. 

“To do that, you have to use some accompanying disclaimer that will explain to consumers the level of science involved,” Mister said. “These can get cumbersome quickly. And the qualification can be longer than the claim itself. Companies typically have to say the FDA has concluded that the evidence is inconsistent and inconclusive.”

As a result, companies don’t make qualified health claims that often because the qualification can be more trouble than it’s worth.

Avoid Disease Claims

Lastly, there’s one area dietary supplements have to stay away from: disease claims. These are claims that purport to diagnose, mitigate, treat, cure or prevent any disease. They’re prohibited in a dietary supplement. Using a disease claim on a supplement transforms a product into a drug, according to the FDA.

But avoiding disease claims can be trickier than it sounds. If a company uses “COVID-19” as a search term to drive traffic to a website, the FDA might determine that it’s a disease claim because of the implication the product somehow will prevent or treat COVID-19.

“It’s not only what they can see, but sometimes it’s what the consumer doesn’t see,” Mister said. 

There’s an FDA requirement that any statement companies make on the label must have substantiation, that the statement is truthful and not misleading. 

Claim Types in the Context of COVID

To put it into the context of the pandemic, Mister theorized how a company might market a new product against claims in each of these categories.

A nutrient content claim, for example, might involve a supplement that’s a good source of zinc or vitamin D without needing further explanation as to why a consumer would use it.

“Many consumers might know that, for instance, when former President Trump went to Bethesda Naval Hospital for COVID-19, he was given zinc and vitamin D during his course of treatment,” Mister said. “But as long as you don’t reference any of that, you’re simply making a nutrient content claim.” 

Nutrient deficiency claims aren’t relevant, Mister added, because the data hasn’t shown that COVID-19 stems from any nutrient deficiency.

Some structure/function claims companies might make include things such as helping to strengthen the immune system, as long as the company doesn’t mention COVID-19. 

“You might be able to say something like achieving higher levels of vitamin D helps to reduce your risk of COVID-19, but only if you go through that process and can show there’s significant scientific agreement around that statement,” Mister said. “The evidence isn’t strong enough to support something like that yet.”

Any prohibited disease claims would be anything that mentioned COVID-19.

What About the FTC?

When it comes to the FTC, Mister pointed out that the agency isn’t concerned with dietary supplements specifically or which category a product falls into. The FTC wants to know whether a claim is truthful, not misleading, and adequately substantiated. But it’s important to remember that the burden in these cases is not on the FTC to prove falsity when they open an investigation. The responsibility is on the manufacturer to show a claim is truthful and adequately substantiated.

The standard is, “Is there competent and reliable scientific evidence to support the claim?” This is a flexible rule, but the more serious the claim, the more evidence the FTC requires. Hot button issues include anything that says, “clinically proven” or “doctor recommended.” These claims create a much higher level of substantiation.

“If the claim includes something quantifiable, such as ‘receive results twice as fast’ or ‘this absorbs three times better,’ where you’re giving specific numerical comparisons, regulators expect to see substantiation that matches those numbers,” Mister said.

The FTC pays close attention to testimonials and endorsements, especially if they’re a celebrity, blogger, or social media influencer and are getting paid for their work. Companies must disclose that remuneration to the consumer.

Mister added that implied claims are just as dangerous as express claims. For instance, a testimonial that includes something like “I take vitamin C daily and just reordered some to be sure I don’t run out because of COVID-19,” could run afoul of the FTC.

“My general caution is don’t think you can outsmart the FTC,” he said. “These kinds of things, the FTC says, is implicitly tying your product to the pandemic and therefore making an implied disease claim for the product.”

The stakes have never been higher, so little margin for error when it comes to label claims. But when R&D, Legal, and Marketing departments are out of sync, it can make companies vulnerable to risk.

TraceGains Networked Product Development suite allows teams to evolve beyond manual processes to automated results by digitizing and streamlining new product development for quicker innovation. Network connectivity offers instant access to more than two million supplier-provided documents, where development teams can leverage existing supply chain data, specifications, and product-related information to build claims. And a library of more than 300,000 digitally integrated scientific studies lets teams search by health condition, study type, journal ranking, or published date range. Once teams locate the documentation they need, they directly link it to the ingredient or claim, ensuring all associated formulas contain the applicable documentation.

Watch our on-demand webinar featuring CRN President and CEO Steve Mister and TraceGains CEO Gary Nowacki for more details about how dietary supplements companies can ease the burden of health claims substantiation, develop new products faster, and connect teams over a networked platform.