The NUMBER ONE reason why supplements, cosmetics, pet health, superfood, and skincare brands conduct clinical trials is to receive credible and compliant product claims that please the FTC and FDA. Additionally, the NAD (National Advertising Division by the BBB -- Better Business Bureau) is also increasingly sending out warning letters to brands. The ultimate goal of these agencies is to protect consumers from misleading information. Navigating and implementing these guidelines can be nerve-wracking, and we believe that nothing in the clinical trial process causes brands so much anxiety than actually using their claims. Unfortunately, increasingly, brands don't use their claims at all, even though they're excellent because they are scared of legal action. But, while adhering to FTC regulations is a legal requirement, they can also be a pathway to building trust and credibility with consumers. Consumers are more savvy than ever before, and they reward transparency.
The following information is for informational purposes only and should not be considered legal advice.
Understanding FTC Regulations
The FTC’s primary goal is to prevent deceptive and unfair business practices. When it comes to product claims, this means ensuring that any claims made about a product's benefits or effectiveness are truthful, not misleading, and substantiated by reliable scientific evidence. Here are the key elements brands need to understand:
Truthful and Not Misleading:
All product claims must be honest and not omit any information that could make the claim misleading. For any claim a brand makes, the brand must provide evidence supporting this claim. To be on the safe side, Citruslabs recommends that you quantify your study results. If you conducted a study with Citruslabs, we help you pick out the best claims based on your study results and provide them in a transparent format. For example:
86% reported a reduction in the appearance of fine lines and wrinkles
10 lbs average weight change in eight weeks
93% had fewer hot flashes
23% reduction in cortisol levels
41% increase in Vitamin B12
57% showed a significant improvement in sleep quality, significantly greater than placebo
68% presented with clearer skin after 4 weeks
85% saw less hair shedding after 6 months
98% agree that their skin feels more hydrated
Substantiation:
Claims must be backed by reliable scientific evidence. Anecdotal evidence or customer testimonials are not sufficient. The FTC mentions that double-blind placebo-controlled studies are the gold standard of clinical trials. This is true. Many brands opt for this type of randomized controlled trial (RCT). However, these studies are expensive, and you run the risk that you won't get statistically significant results from a placebo. At Citruslabs, our opinion is that as long as you are TRANSPARENT about your study design, it's OK to start with a single group clinical study (or even perception study) and then work your way up to conduct an RCT later.
Clear and Conspicuous Disclosures:
Any necessary disclosures must be clearly and conspicuously presented so that consumers can easily understand them. This includes any qualifying information that might affect the consumer's understanding of the claim. For example, the FTC thinks that when consumers see a "clinical trial," they automatically think it is an RCT. This is why it's super important when you use claims that came from a single-group clinical trial or a perception study to disclose your study design and be transparent about it. Ideally, you also list your methodologies (how you collected the data, i.e., blood tests, questionnaires, trackers, microbiome testing, etc.), and some information about your study population.
Key Areas of Compliance
Health Claims:
Example: Claims that a supplement "boosts immune function" must be supported by scientific evidence demonstrating this effect.
Compliance Tip: Ensure that all health-related claims are substantiated by clinical studies, ideally RCTs that have been peer-reviewed and published.
Performance Claims:
Example: A cosmetic product claiming to "reduce acne by 50% in two weeks" must have clinical trial data to support this statement.
Compliance Tip: Conduct rigorous testing and maintain detailed records of all studies to substantiate performance claims.
Environmental Claims:
Example: Claims such as "eco-friendly" or "biodegradable" must be backed by evidence proving these environmental benefits.
Compliance Tip: Ensure environmental claims meet the FTC’s Green Guides, which provide guidance on making truthful environmental marketing claims.
Recent Regulatory Updates
The FTC periodically updates its guidelines to address new market trends and emerging products. Staying informed about these updates is essential for ongoing compliance. Recent areas of focus include:
CBD Products: With the rise of CBD products, the FTC has emphasized the need for strong scientific evidence to support health claims related to CBD.
Digital Advertising: As more brands use digital platforms for marketing, the FTC has updated guidelines on how to make clear and conspicuous disclosures in online advertisements.
Best Practices for Brands
Conduct Thorough Research: Before making any claims, conduct extensive research in the form of clinical trials and ensure that the evidence is robust and reliable. This might involve working with independent research organizations like Citruslabs.
Consult Legal Experts: Engage with legal experts specializing in FTC regulations to review your marketing materials and claims. This can help identify potential issues before they become regulatory problems. But be cautious when attorneys start to design your study. While they probably have good intentions, let actual researchers with content expertise design your study.
Stay Updated: Regularly review FTC updates and guidelines to ensure your brand remains compliant. Subscribe to FTC newsletters or follow industry news to stay informed about regulatory changes.
Implement Internal Controls: Develop internal processes for reviewing and approving marketing claims. This might include setting up a compliance team or using checklists to ensure all claims are substantiated and disclosures are clear.
Navigating FTC regulations on product claims can be challenging, but it is essential for building a reputable and trustworthy brand. You can avoid regulatory pitfalls and enhance consumer confidence by ensuring that your claims are truthful, substantiated, and clearly disclosed. Stay informed, consult experts, and implement robust compliance practices to navigate these regulations effectively and successfully.
For more detailed guidance or assistance with compliance, consider partnering with Citruslabs, a leading provider of clinical trial services for supplements, cosmetics, superfoods, pet health, and skincare brands. Our expertise can help ensure your product claims meet FTC standards and resonate positively with consumers. Contact us HERE.
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