Is FDA watching heart health supplements in 2023? 2023 Ingredient trends for food, drinks, dietary supplements, and natural products

Grebow,Jennifer;

Is FDA watching heart health supplements in 2023? 2023 Ingredient trends for food, drinks, dietary supplements, and natural products

January 24, 2023

By Jennifer Grebow

Publication

Article

Nutritional OutlookNutritional Outlook Vol. 26 No. 1

Volume 26

Issue 1

FDA warning letters in 2022 remind cardiovascular product companies about what they should and shouldn’t do in 2023.

Photo © AdobeStock.com/ jarun011

Heart health is still an important dietary supplement market in the U.S. Despite sales not growing much last year, the cardiovascular category remains a top-10 health focus in both the natural and mainstream U.S. supplement markets, says Haleigh Resetar, corporate communications specialist at SPINS (Chicago). In fact, Resetar expects heart health products to get a bit of a boost in 2023 “as more people continue to get into performance and continue to get into those energy-support health focuses,” she says.

Studies demonstrate that numerous nutraceuticals can help consumers support a healthy heart. But as every supplement stakeholder knows, or should know, there are strict rules about what companies can and cannot say when marketing their products’ health benefits. Run afoul of those rules and you’ll likely get a warning letter from FDA.

Case in point: In November 2022, FDA sent warning letters to seven dietary supplement companies selling heart health products. The companies, the agency said, made illegal disease claims that render their products misbranded drugs instead of legal dietary supplements.

Was FDA’s censure justified? To find out, we interviewed prominent supplement-industry attorneys and experts. The majority say FDA’s action is not surprising considering the claims the companies were making for their products and/or the ingredients in them. Those claims included:

Cholesterol Claims

“lowering cholesterol”
“may lower cholesterol”
“reduces cholesterol”
“reduce high cholesterol”
“clinically shown to decrease cholesterol”
“clinically proven to improve cholesterol levels”
“helps you keep cholesterol levels under control”
“helps reduce LDL levels”
“improves LDL levels”
“help your body lower bad cholesterol levels”
“aids your body in potentially lowering bad cholesterol levels”
“protect your heart by lowering bad cholesterol”
“has been shown to lower LDL cholesterol by helping inhibit cholesterol production in the liver”
“significantly decreases total cholesterol and bad (non-HDL) cholesterol without decreasing good HDL cholesterol”
“encouraging higher ‘good’ cholesterol levels, your body is better able to clear out the bad cholesterol building up within arteries and naturally manage cholesterol levels”
“work by helping reduce enzymes that break down ‘good’ HDL cholesterol while also preventing cells from releasing the low-density lipoproteins that can cause cardiovascular issues.”
“patented to stabilize and regress vulnerable plaque”
“cause a significant reduction of atherosclerotic plaque”
“have been shown in studies to help lower ‘bad’ LDL cholesterol levels as well as triglycerides and even blood pressure”
FDA noted that one of the product’s names included the word cholesterol. FDA said this amounts to an implied claim that the product reduces cholesterol.

Inflammation Claims

“anti-inflammatory”
“clinically shown to reduce inflammation”
“inhibits endothelium-mediated inflammation”

Blood Vessel Function

“improve blood vessel function”
“may improve health of blood vessels in those with…heart disease”

Blood Pressure

“may lower blood pressure”
“potential to lower blood pressure”
“ability to reduce blood pressure”
“shown to help reduce blood pressure”
“lowered diastolic blood pressure”
“lower blood pressure naturally”
“ingredients from nature that address multiple factors to help regulate blood pressure”
“can lower your high blood pressure naturally and fast”
“may help control high blood pressure and cholesterol by increasing coronary artery blood flow and improving circulation”

Other Claims

“reduce major adverse cardiovascular events”
“popular ingredient used to fight back against blood pressure, blood disorders, and heart disease”
“readily increases the Omega-3 Index, a biomarker for reduced cardiovascular risk”

A Fine but Definite Line

To the layman, some of the above claims like “helps you keep cholesterol levels under control” or “encouraging higher ‘good’ cholesterol levels” may not sound like egregious disease claims akin to stating that a product “cures heart disease.” But there is a problem: the fact that these companies did not restrict themselves to stating that their products maintain cholesterol levels or blood pressure levels already within a healthy range.

Kristi Wolff, partner in the advertising practice group at the law firm Kelley Drye & Warren LLP (Washington, DC), says that “claims relating to cholesterol or blood pressure could potentially be appropriate for dietary supplements if they focus on maintaining normal levels—e.g., ‘helps to maintain blood pressure already in the normal range.’” But, she says, “It does not appear, based on the warning letters, that FDA was taking issue with ‘already in the normal range’–type claims, however.”

She continues: “Any time a product features a claim that the product or the ingredients in the product can take someone from a disease state to a healthy state, there is a risk that the claim is a disease claim. These warning letters focus on products that claim to help users control or reduce cholesterol or blood pressure. Given that cholesterol levels and blood pressure are biomarkers or symptoms for heart disease, claiming to be able to reduce or control them—i.e., claiming to treat a symptom of heart disease—can be considered a disease claim. From that perspective, I was not surprised by these warning letters.”

Listen Now!

Don’t miss the January episode of The Nutritional Outlook Podcast in which we interview Scott Dicker and Haleigh Resetar of SPINS about all of our editors’ picks for 2023 Ingredients to Watch.

Click here to listen.

Not all brands grasp the bright line separating structure-function claims and disease claims.

“This is a somewhat subtle distinction, but it is important to FDA, which has taken the position that ‘lowering cholesterol is inextricably linked in the public mind with treating elevated cholesterol and preventing heart disease,’” says Samuel Butler, counsel at Lathrop GPM LLP. “Generally speaking, disease claims are off limits and structure-function claims are permitted, but there are several places—cardiovascular issues being a primary example—where the distinction can be counterintuitive and requires an experienced eye to spot.”

Rend Al-Mondhiry, partner at Amin Talati Wasserman LLP, adds, “The line between structure-function claims and implied disease claims is especially blurry, and it’s not always apparent when a claim that mentions cholesterol, blood pressure, or even blood sugar crosses that line. The overall context usually informs risk, but qualifying the claim in these instances is key.” Unfortunately, she says, some marketers avoid adding the necessary qualifying language like “cholesterol levels already in the normal range” to marketing claims, believing it makes their marketing less attractive.

Context Matters

But they would be wise to get over that aversion. Centering claims and marketing language on normal bodily functions prevents a company from overstepping the line.

“Companies can stay in the ‘safe zone’ with appropriate structure-function claims such as ‘supports cardiovascular health’ and ‘helps maintain healthy cardiovascular function’—or by qualifying blood pressure and cholesterol claims to refer to levels already within the normal range,” says Al-Mondhiry.

Past FDA guidance spells this out. “FDA’s guidance on the distinction between disease claims and structure-function claims goes back to 1998 when the FDA first proposed regulations to respond to the authorization of structure-function claims in the Dietary Supplement Health and Education Act of 1994,” says Butler. “Already in the very earliest guidance, FDA was addressing where the disease-claim line was for cardiovascular claims like cholesterol and blood pressure levels.”

Al-Mondhiry recommends that industry members refer to the preamble to the final structure-function rule which addresses regulations around a variety of endpoints.

Megan Olsen, senior vice president and general counsel at the Council for Responsible Nutrition, says that FDA “talks about cholesterol claims quite a bit” in its guidance. “I think there’s great guidance out there on cholesterol claims from FDA, some of which is older but actually likely still relevant.”

The bottom line? “I just really stress that context is key here,” Olsen says. She continues: “Companies can certainly talk about cholesterol as a structure-function claim. They have to be very careful about how they phrase those claims. Context and the claim language itself are very important here.”

Mentioning other disease claims, of course, raises a red flag. Butler points out that many of the products that received FDA warning letters had “additional disease claims thrown in for good measure, like reducing the risk of heart disease, reducing the risk of ‘major adverse cardiovascular events,’ or reducing high blood pressure.”

Dos and Don’ts

Which claims should heart health products definitely avoid?

“Companies should avoid any plaque-reduction [and] cholesterol- and blood pressure–lowering claims, especially in the context of disease prevention and treatment,” says Ashish Talati, partner at Amin Talati Wasserman LLP.

“Anything a drug is indicated for, such as ‘lowering LDLs,’ is considered a claim. The rationale for this is that drugs treat, diagnose, prevent, or cure disease,” adds Asa Waldstein, principal of consulting company Supplement Advisory Group.

Carefully consider the biomarkers you mention, he says. “Biomarkers can fall under the ‘treatment or prevention’ part of this and can therefore be considered disease mitigators.” He advises avoiding statements related to “bad fats, bad cholesterol, ventricular contractions, mitigating arterial and venous plaque, and lower blood pressure.”

Also, adds CRN’s Olsen, “I think inflammation is an area to be very concerned and careful about.”

“Marketers and companies need to carefully scrutinize their claims,” she says. “If they’re providing the benefits of the product in a way that the product is supporting a bodily function—a healthy, normal bodily function—this is something they can absolutely talk about. They just want to look at their overall marketing and their labels and their claims to help ensure that what they’re conveying is that this product is here to help you maintain a healthy lifestyle and is not a substitute for disease-treatment options.”

This review should be applied to all channels where companies market products, including a company’s own website, social media and any testimonials, and claims on external retailer sites like Walmart.com and Amazon.com. FDA’s November warning letters cited companies for infractions on all of those platforms.

“It is also vital for companies to ensure they are re-reviewing old blogs and social posts as FDA looks at several-year-old-posts as a current marketing piece,” Waldstein adds. “Companies may have a robust regulatory review of existing marketing copy, but they often overlook those ‘forgotten’ old posts that may have been less scrutinized.” FDA also looks for noncompliant hashtags like #hypertension, he says.

Companies can be alerted early on to any problems the agency sees when they notify FDA of their structure-function claims, Olsen points out. “It’s your opportunity to flag a claim for FDA and have them say back, ‘No, we don’t agree that it’s an appropriate structure-function claim,” she says. “FDA will be very clear. Again, that’s not an approval, and there could be instances where you don’t get an objection from FDA and potentially down the road there’s a concern from FDA. But it’s just another mechanism…a way in which you can help ensure that you have at least put something in front of the agency to work through these context issues.” In short, she says. “You definitely want to have your dialogue with FDA through that process. It’s very important.”

The Future

If anything, FDA’s recent spate of heart-health warning letters serves as a reminder to industry to mind their regulations when making health claims. It’s a gut check for other types of companies as well, such as those targeting mental support. (FDA also sent warning letters to a group of those companies last year.) Says Olsen: “There could be areas where you’re talking about just helping with occasional stress and relaxation, where that is an appropriate structure-function claim. But then, of course, if you’re going to be talking about managing anxiety and other things that could trigger serious mental health disorders, you would be moving into disease-claim territory.”

It’s also a flag that FDA tends to send warning letters in batches these days.

Al-Mondhiry says that “we are seeing a trend of FDA issuing groups of warning letters in conjunction with a press release, where FDA is sending a broad message to industry regarding these types of claims.” Talati similarly says FDA has “focused on sending mass letters on a specific category to make sure the industry is put on notice.” In 2021, for instance, he says FDA sent a group of warning letters addressing diabetes claims.

Olsen agrees: “I will say we see FDA taking positions more and more in this type of context where they will pull together a group of warning letters and issue them all at once, I think so that they can alert industry to concerns with particular claims or actions and be able to put out a statement around what they think is appropriate versus not appropriate and compliant behavior in the industry.”

Looking back at November’s letters, “It’s fair to say that the agency’s positions regarding cholesterol, blood pressure, and disease claims are not new,” says Wolff. “Rather, this may be a reminder to companies that the agency is still watching these kinds of claims.”

So, in 2023, cardiovascular product marketers should proceed—but proceed with caution. As Waldstein says, “What was medium risk yesterday can be high-risk tomorrow.”

Companies need to be able to truthfully talk about the benefits of their products—but to talk about them responsibly, too. “Cardiovascular health is obviously an extremely important issue in the United States, and it is unsurprising that supplements makers want to make these sorts of claims,” says Butler. “There are many permissible claims that can be made, but it is essential for companies to keep in mind where the line is between permissible structure-function claims and impermissible disease claims.”

Download Issue PDF

Articles in this issue