At Natural Products Expo East 2021, which took place in Philadelphia, PA in September, Todd Harrison and Claudia Lewis, both partners at Venable LLP, discussed a collection of anticipated regulatory and legal developments on the horizon. Also up for discussion were some of the ongoing impacts that the COVID-19 pandemic has had on the regulatory status of a variety of dietary ingredients and finished products.
 
COVID-19 and Regulatory State of Affairs
Between a degree of flexibility offered by the U.S. Food and Drug Administration (FDA), and developments in the enforcement of health claims, the nutraceuticals industry should be aware of a number of key developments, which changes might last, and which adjustments are intended to be temporary.
 
Due to supply shortages experienced intermittently since the pandemic began, FDA has been more flexible with supply chain issues than before; while many changes in enforcement discretion were intended to be temporary, some may last, Harrison said.
 
For example, FDA has provided exceptions relevant to food and beverage market, now allowing what it considers to be minor substitutions, such as substituting unbleached flour for bleached flour, or one artificial flavor for another artificial flavor, Harrison said. “Nonetheless, it’s important to be careful because while minor changes may be fine from an FDA perspective, that might not necessarily be true when it comes to the perspective of a client.”
 
While some formulation changes are straight forward (such as having no allergens, making up less than 2% of the weight of a finished food, or not a “prominent” ingredient subject of label statements), other minor formulation changes fall into a greyer area, Harrison said. For example, “minor” changes that FDA currently considers acceptable include ingredients which aren’t “characterizing” of a product, changes which have no effect on voluntary nutrient or health claims, or have “no significant impact” on nutrition or function of finished food.
 
Beyond the obvious warnings hammered down by FDA regarding COVID-19 claims, there is some nuance when it comes to immunity-related health claims FDA is concerned with, Lewis noted. “On some more egregious COVID-19 claims, FDA has issued warning letters which state that the agency isn’t even sure that ingredients in question are dietary ingredients, as they did with NAC supplements, which has caused serious problems for companies with Amazon and a number of brick-and-mortar retailers.”
 
“FDA has been equally aggressive with certain immune support claims,” Lewis continued. “Certain contexts which might even suggest COVID have been targeted by warning letters. Twenty four months ago, if someone used the word ‘immunity’ it certainly wasn’t a high risk type of claim, but that’s completely changing due to FDA and FTC’s new focus and interpretation of these claims.”
 
“The word ‘immunity,’ and especially the word ‘respiratory,’ are persona non gratas,” Harrison said. “These words are ‘saying’ COVID, according to FDA’s thinking, and just because one brand will get away with a certain claim doesn’t mean other companies will.” When it comes to the two-pronged enforcement approach FDA and the Federal Trade Commission (FTC) have taken against COVID-19-related health claims, “FTC is naturally concerned about COVID claims and their main area of concern has to do with substantiation. However, the FDA essentially believes there are no forms of substantiation in existence for COVID, and these investigations are being heavily expedited.”
 
Food Labeling Modernization Act
Harrison shared a number of legal and ethical qualms he had with a new legislation proposal, a bill known as the Food Labeling Modernization Act (FLMA) which would require certain types of nutrition information to be included on front-of-pack labeling. While summary information in and of itself on basic nutrition facts is already covered on Nutrition Facts and Supplement Facts labels, and more prominent allergen declarations are straightforward, there would certainly be a number of ramifications and additional regulatory oversight FDA would be granted upon its passage.
 
For example, brands would be pressed by the agency for more information, even for simple structure/function health claims which have been a staple of marketing, Harrison said. “The legislation requires food manufacturers and importers to submit to FDA all information which is required to be on the label, and to submit updates to keep information on file current with FDA, but it also allows FDA to demand substantiation for express and implied health claims for food from the manufacturer, at which point the manufacturer has 90 days to respond with sufficient documentation.”
 
“This would turn everything upside down and on its head,” Harrison continued. With structure/function health claims being relatively open to interpretation based on nutritional profiles, and with FDA taking conservative stances when it comes to health claims on products in its jurisdiction, Harrison believes the agency would place much more severe restrictions on the types of health claims brands can make. “FDA is an agency which doesn’t really believe that nutrition matters,” Harrison said. “Further, they don’t have anyone at hand to do this, and it’s treading deeply into the jurisdiction of the FTC.”
 
Lewis echoed this sentiment, noting that the agency might not be properly equipped to devote resources to vetting every structure/function claim on the supplements market. “Even when DSHEA [Dietary Supplements Health and Education Act] was passed, the agency was totally overwhelmed. For that reason, I think this is one step backward. Foods don’t have express health claims to begin with, so I’m not sure what the purpose of this legislation actually is.”
 
Furthermore the FLMA would allow FDA to place warning labels on the front of packages, Harrison noted. However, this type of front-of-pack messaging can go awry, and has done so in the past. “Look at the increase in rates of diabetes and metabolic syndrome since the mid-80s – what happened back then? The FDA allowed companies to put ‘low fat’ claims on products which were simply stripped of fat and packed with simple carbohydrates – FDA didn’t work with the understanding that fat satiates and is part of a healthy diet, and obesity has gotten worse since.”
 
“Nutrition has continued to evolve […] there’s no one definition of health, and if so, what would it be? We don’t need Congress, or the FDA, who’ve done many things wrong over the years, telling us how to define it,” Harrison continued.
 
Class Action Concerns
Concern about the potential for class action lawsuits against products with certain health claims remains high in the nutraceuticals industry, Harrison and Lewis said.
 
With companies’ social media presence under scrutiny by law firms which target these health claims, some of which can be relatively ambiguous, it may be more important than ever to be wary of inferences, and contexts, in which certain health claims are made. “Social media at this time is definitely helping class action lawsuits rather than hurting it, and it’s feeding the perception that people have the ability in court to say that a consumer was deceived based on a social media post,” Lewis said.
 
“Even words such as ‘natural’ or ‘wholesome’ can be highly contextual when it comes to class action lawsuits,” Lewis said. Class actions have historically taken the lead on what kinds of claims can or cannot be legally made in the nutraceuticals industry, she added, and often serve as better guideposts in terms of avoiding litigation compared to warning letters, which are issued rather sparingly and with little enforcement action following them up.
 
Harrison noted that the definition for “natural,” in this context, differs depending upon which regulator you ask. USDA, for example, considers a “natural” ingredient to be one devoid of any artificial flavor or coloring, chemical preservative, or synthetic ingredient, and not more than “minimally” processed. On the other hand, FDA requested comments on how the agency should define “natural” in 2006 but has not issued a single rule or policy, and FTC holds no official position on marketing products as natural.
 
“Class action lawsuits seize upon these technical issues,” Harrison said. “The regulations surrounding these terms are outdated, archaic, and need to be updated, but no one does anything about it.”
 
“Some products have had low sugar claims, but have failed to mention that a food is not low-calorie. Even with calorie information, this is still something that class action lawsuits would target with ease,” Harrison said. Many class action suits specifically challenge characterizations of the presence of a certain ingredient as “healthy,” he noted, even though there are no clear rules or regulations that lay out which products can meet the definition of healthy.

---

Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at MMontemarano@RodmanMedia.com.