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This is part 2 of the insights from Taking the stress out of claims in the US. Insight and content provided by Ivan Wasserman & Jennifer Adams of Amin Talati Wasserman.
According to the IPSOS Nutiani Consumer Wellness Research1 , 92% of Americans pay attention to product attributes when purchasing products to keep healthy, including health benefit claims.
Maintaining compliance in what is now a very complex regulatory landscape will not only ensure your products remain on the shelves, but also help build long-term brand credibility and consumer trust.
All marketing claims must be truthful, not misleading and adequately supported. Although the Food and Drug Administration (FDA) can regulate this, a claim’s accuracy is primarily overseen by a different agency: the Federal Trade Commission (FTC).
The FTC expects health claims to be supported by ‘competent and reliable scientific evidence’, also known as CARSE.
CARSE is defined as "tests, analyses, research, studies or other evidence-based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."
While CARSE appears to be a flexible standard, its enforcement history shows the FTC expects products that are making an unqualified structure/function claim to to be supported by at least one human clinical study that:
The above reflects the gold standard. That said, even studies that do not satisfy all these criteria may still play a role in substantiating a claim. Scientific evidence used to support a claim is looked at in its totality. It is possible that two or more studies that each have weaknesses may support a claim when combined. Conversely, it is possible that a claim may be rejected if a more robust study refutes its benefits.
The importance of a placebo control cannot be overstated, especially for subjective outcomes such as feelings of stress and calmness. While non-placebo-controlled studies provide helpful background information and are an important step in a clinical research plan, they are not likely to support health claims on their own.
When substantiating stress-related claims, key considerations will be the population studied and assessment tools used. Subjects should ideally be people who report feeling daily stress, but not in such a way that they qualify as having a stress-related disorder. As it is challenging to objectively measure feelings of stress or calmness, any subjective assessment tool used (e.g. questionnaires) must be validated.
Additional considerations arise if the substantiation for the claim is based on an ingredient rather than the product. Brands need to ensure the study on the ingredient is CARSE and applicable to the finished product’s target market. For instance, a robust study on an ingredient that involves only male subjects may not be CARSE for a product targeting women.
Another common issue is underdosing. If the product is providing less of the ingredient than what was included in the study, it is unlikely to meet the CARSE standard to support the claim.
In addition, all messaging must make it clear to consumers that the ingredient is the basis of the claim (e.g. “with ingredient X, to help you relax from daily stresses”).
Finally, it is important to use only scientifically backed ingredients from reputable suppliers. They should be willing share information on the quality of their products and accompanying evidence. The FTC will insist on reviewing the studies of suppliers, so brands should do the same when deciding on the source of their ingredients.
The main gatekeepers you need to be aware of:
The FTA and the FTC are not the only enforcers of compliance. Other regulatory groups to be aware of include:
The good news is that well substantiated stress-related claims are possible. Vet your suppliers, assess your substantiation, and with this greater understanding of what’s required, your compliance should be stress free.
Managing Partner, Amin Talati Wasserman
Offering a unique combination of legal acumen, marketing savvy, and deep industry knowledge, Ivan Wasserman serves as one of the nation’s premier attorneys for health, wellness, beauty and other consumer products.
Partner, Amin Talati Wasserman
With a food science background and a love for nutrition and wellness, Jennifer provides a unique perspective to her clients in the food, beverage, supplement, cosmetic, drug, and animal product industries.