This leads to warning letters, competitor challenges and lawsuits, but it can be confusing to know how to discuss ingredients and products without crossing the compliance line or becoming an easy lawsuit target. In this article, I’ll review enforcement trends and best practices to help keep you out of trouble while continuing to educate your consumers and grow your business.
When reviewing content for regulatory marketing compliance, it’s important to look through the lens of different regulatory agencies or groups that can lead to issues. Here are some high-level bullet points to demonstrate the differences.
- FDA is primarily concerned with product safety and ensuring companies do not make disease claims, such as Alzheimer’s.
- FTC focuses on ensuring advertising is truthful, substantiated, and not misleading. To distinguish from the FDA, the FTC may allow dietary supplement disease claims if they are presented truthfully and have solid scientific substantiation, such as a well-powered Randomized Controlled Trial (RCT) on the finished product. This doesn’t mean companies should make disease claims about dietary supplements, but it helps to showcase the differences between these two regulatory agencies.
- NAD is a self-regulatory body under Better Business Bureau (BBB) programs. NAD assesses the truthfulness and accuracy of advertisements and provides a streamlined process for resolving advertising disputes.
- Plaintiff attorneys send demand letters or initiate class action lawsuits, which are expensive to defend and settle. The basis for these lawsuits often cites false advertising allegations, but it is common for compliant structure-function claims like “focus” to trigger lawsuits, as the cost of defending the case is often much more than a quick settlement.
FDA’s Small Entity Compliance Guide for Structure-Function Claims is a great reference for understanding FDA’s thoughts on what constitutes an allowable or disease claim. For example, it states that “mild memory loss associated with aging” is an acceptable structure-function claim while “severe memory loss associated with aging” would be a disease claim.
Interestingly, the following statement was ruled to be materially misleading in this recent Prevagen case ruling. The company is forbidden from making this product claim and any of the other challenged claims, which highlights that even if a company is not making ultra-high-risk disease claims, it still must have reliable and defensible scientific evidence. This is particularly true for memory-related claims.
- Example of forbidden claim in recent court rule: “Prevagen reduces memory problems associated with aging.”
“Focus” and “cognition” warning letter enforcement: Marketing statements related to “improved focus” or “enhanced cognition” are sometimes mentioned in FDA warning letters, but these are typically only cited when bold disease claims like depression are present. There have also been several warning letters issued to companies selling dangerous smelling-salt products that also make cognitive and focus claims. If there were no hazardous products, GMP issues or high-risk disease claims present, FDA probably wouldn’t have issued these warning letters.
- Crossing the line: Oftentimes, cognitive issues may be related to medical concerns like Alzheimer’s, dementia, fibromyalgia or traumatic brain injury. These types of statements tip the scale to a company receiving a warning letter.
“Concentration” claims: These types of claims are not typically enough to warrant an FDA warning letter.
- Crossing the line: There can be many reasons, such as stress, as to why people have trouble concentrating. “Occasional stress” is not a high-risk statement, but “chronic stress” is. This is because we all have stress from time to time, but ongoing or chronic stress is often the result of disease. Also, implying helping with concentration related to ADHD, or claiming to be better than drugs like Adderall is a great way to irritate FDA and elevate the likelihood of a warning letter.
“Brain Fog” claims enforcement: I am often asked if this is an allowable claim, and the answer is “it depends.” According to the Department of Health and Human Services (HHS), brain fog can be a symptom of long-haul COVID, which is recognized as a disability under the Americans with Disabilities Act (ADA). “Brain fog” without any connection to COVID or serious diseases is unlikely to attract a warning letter, in my opinion.
- Crossing the line: “Brain fog” linked to COVID symptoms is clearly a disease claim. This includes when hashtags such as #COVID or #LongHaul are added to a brain fog-related social media product post.
Litigation Triggers
Understanding litigation risks is where marketing compliance gets even more nuanced. For example, if a company makes substantiated and compliant structure-function claims, it may not be protected from lawsuit risk. This is especially true for claims made on packaging compared with secondary marketing such as websites or social media. Here, I explore some of the common litigation triggers in the cognition space and discuss how to mitigate your risk.
Quantifiable claims: A plaintiff attorney’s dream come true
Stay away from quantifiable numbers that increase the risk of scrutiny, like “85% memory improvement.” One reason is that the subjectivity of cognitive benefits, such as improvements in memory or cognitive function, makes them challenging to measure reliably, leaving claims vulnerable to being deemed misleading.
Clinically proven statements: A litigation magnet
Making on-package “clinically proven” claims is the quickest way to attract lawsuits or FTC attention. This is because the substantiation standard is not always clear unless a company has a well-powered, Randomized Controlled Clinical (RCT) that meets scientific agreement standards on all label claims. The Prevagen case can teach us a lot. Here is one of the noteworthy challenged statements that was a trigger for the case: “Prevagen is clinically shown to improve memory within 90 days.”
Avoid definitive terms: Difficult to substantiate
Absolute or definitive terms like “guaranteed” and “100% effective” should be avoided as they are difficult to substantiate. The courts will look at the consumer net impression and will include all label statements. For example, if a product label lists “improved sleep” and “100% effective,” a reasonable consumer would expect this to work for sleep every time, and the company would be expected to have competent and reliable scientific evidence supporting this.
Asa Waldstein is principal of the consulting company Supplement Advisory Group, a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. He is the founder of the compliance software company Apex Compliance. He also chairs the American Herbal Products Association’s (AHPA) Cannabis Committee. This article is informational only and does not replace competent legal or regulatory review. Learn more and contact him at AsaWaldstein.com.