Health Claims Substantiation for Risk-Free Innovation

Health Claims Substantiation for Risk-Free Innovation

Denis Storey
September 24, 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 remain acutely aware of how much work goes into product label claims – and how much trouble awaits them if they get it wrong. But what many companies don’t fully understand is how regulators perceive – and respond to – online marketing.

Regulators treat dietary supplements labeling differently than traditional advertising. The U.S. Food and Drug Administration (FDA) focuses primarily 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” reaches beyond the label itself.

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 claim everything online, Mister points out, including social media. The FDA would say, in most cases, online claims are “labeling,” while the FTC insists they’re “advertising.”

What’s perhaps even more problematic for dietary supplement makers is that both agencies have started collaborating more closely since the start of the pandemic, increasing regulatory scrutiny across the industry.

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 if companies follow the requirements outlined in the existing regulations.

The Nutrition Labeling and Education Act (NLEA) originally authorized nutrient content in food and dietary supplements and predated 1994’s Dietary Supplement Health and Education Act (DSHEA).

“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. So, 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 ingredients 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 claim a dietary supplement related to one of these diseases because they’re directly associated with nutritional status. But the law requires that if companies make one of these claims, they must 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, which consumers remain most interested in, is structure/function claims. These claims describe the role a nutrient or ingredient designed to affect the structure or function of the human body. For example, 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 must notify the FDA,” Mister said. “That doesn’t mean they get a premarket review. But you must 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 wouldn’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 must 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 pointed out. “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 continue to be a point of contention. A health claim states that the food component or dietary ingredient might reduce the risk of a disease or other health-related condition. And like nutrient content claims, these predate DSHEA.

“These claims don’t promise disease prevention but reduce 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 often don’t make qualified health claims because the qualification can be more trouble than it’s worth.

Avoid Disease Claims

Lastly, there’s one area dietary supplements must stay away from: disease claims. These are claims that purport to diagnose, mitigate, treat, cure, or prevent any disease. The law prohibits these claims 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. For example, 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 helping 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 rule is flexible, 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 celebrities, bloggers, or social media influencers 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 such as “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, are implicitly tying your product to the pandemic and therefore making an implied disease claim.”

The stakes have never been higher, so there’s little margin for error regarding label claims. But when a company’s R&D, legal, and marketing departments operate out of sync, it exposes brands to greater 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.

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