FTC Counsel

Are you looking for FTC Counsel? The Federal Trade Commission (FTC) shares jurisdiction with the Food and Drug Administration (FDA) over foods, supplements, cosmetics, over-the-counter (OTC) drugs, and medical devices. While the FDA has jurisdiction over the products (including labeling), facilities (manufacturers, distributors), FTC has authority over the advertising of these same products. The FTC protects the public from unfair and deceptive business practices and competition, which includes ensuring consumers receive truthful and accurate information about product advertising.

Therefore, the FTC and the FDA require that all product claims be true, not misleading, and adequately substantiated. Our practice emphasizes helping businesses avoid FTC enforcement altogether by proactively evaluating their claims and reviewing evidence of substantiation before content goes live. At MyFDALawyers.com, PC, our FDA lawyers have extensive experience providing FTC counsel to businesses and entrepreneurs. We are here to help you navigate the full range of FTC matters for food cosmetics, supplement, drug, and medical device marketing. Contact us today for a confidential, no-obligation initial consultation to discuss your specific needs.  

An Overview of FTC Claims Regulation of Foods, Drugs, Medical Devices, and Cosmetics

The FTC plays a major role in the labeling and marketing of foods, dietary supplements, drugs, medical devices, and cosmetics. While the FDA oversees product safety, labeling, and manufacturing standards, the FTC ensures that advertising claims are truthful, non-deceptive, and substantiated by sufficient evidence. Here are some of the key points that businesses and entrepreneurs should be aware of:

1. Advertising Must Be Truthful and Not Misleading: The FTC requires that all promotional content for regulated products be both factually accurate and not likely to mislead consumers. Among other things, it includes statements made in print ads, television commercials, websites, social media, influencer content, and product packaging. Any omission or exaggeration that could materially affect a consumer’s purchasing decision could be a violation of FTC regulations. Careful advance review can help ensure promotional content meets these standards before publication.
2. Health and Efficacy Claims Must Be Substantiated With Reliable Evidence: Companies must have adequate substantiation for all objective claims. Particularly for health, wellness, or performance claims this means competent and reliable scientific evidence. Our team works closely with clients to evaluate substantiation strategies to reduce FTC scrutiny before marketing begins.
3. There are Serious Sanctions for Violations: The FTC has the authority to impose penalties against businesses that are engaged in any type of deceptive advertising. Notably, there can be significant penalties even for first-time violations. However, most adverse enforcement actions are avoidable. Our goal is to identify potential claim issues before they reach a regulator’s desk.

Beyond the FTC: The Role of the Better Business Bureau’s National Advertising Division

In addition to the FTC, the Better Business Bureau’s National Advertising Division (NAD) privately enforces FTC standards and then reports violations to the FTC, the FDA, and private class action attorneys. This can lead to significant regulatory, legal, and monetary consequences. The NAD reviews national advertising for truthfulness and accuracy and encourages voluntary compliance through a self-regulatory process. While NAD decisions are not legally binding, refusal to participate or comply can trigger formal FTC action. We help businesses prepare for NAD inquiries and structure their advertising to minimize the risk of scrutiny.

By hiring an attorney with both FTC and FDA experience, you can reduce your chances of facing FTC, FDA, and private enforcement actions. Our firm is committed to resolving issues before they arise. We focus our work on proactive compliance. Among other things, it includes evaluating claims, substantiation, and marketing strategy. You will also have a lawyer to represent you if the FTC brings a Civil Investigative Demand (CID) or NAD sends you an inquiry about your advertising. If you have any specific questions about an FTC matter, an FDA lawyer with experience handling these cases can help you determine the best course of action.

What to Know About FTC Claims Substantiation

The key to understanding FTC law is understanding the principle of “adequate substantiation,” which requires that advertisers have a reasonable basis for any express or implied claim before dissemination. This standard varies based on the nature of the claim, the type of product, the consequences of a false claim, and how consumers are likely to interpret it.

For health-related claims, the FTC applies a higher substantiation standard: “competent and reliable scientific evidence.” This generally means testing, analysis, research, or studies that have been conducted and evaluated in an objective manner by qualified experts, using procedures generally accepted in the scientific community. In practice, this often means well-controlled human clinical trials, particularly when claims involve disease treatment, prevention, or mitigation.

The substantiation must also match the claims made — both in terms of strength and specificity —  and advertisers must ensure they disclose material information that could affect consumer interpretation or use of the products. We help businesses align their claims and evidence before marketing begins, reducing enforcement risks by thinking like both the FTC and the consumer.

Terms to Familiarize Yourself With

To best understand FTC regulations for foods, dietary supplements, OTC drugs, medical devices, and cosmetics, it is useful to understand some of the most common terminology in the industry. Here are some of the most notable terms that you should familiarize yourself with:

• FTC – The Federal Trade Commission, which is tasked with regulating advertising, among other things. It ensures that consumers are not misled by false or unsubstantiated claims in the product marketing, including dietary supplements, human and animal foods, drugs, cosmetics, and medical devices. The FTC works alongside agencies like the FDA but focuses on advertising materials across all media platforms.
• CID – A Civil Investigative Demand, which the FTC may issue when it begins an investigation into whether a law has been violated. In the CID, the FTC will demand various documents. If you are at this stage, then you need legal representation immediately. With the right preemptive steps, businesses can often avoid reaching this stage entirely.
• NAD – The National Advertising Division of the Better Business Bureau is a private self-regulatory body that initiates cases on its own or after an industry member (i.e., your competitor) pays it a fee. When the NAD initiates a case, it demands evidence of claims substantiation. If the NAD is unsatisfied with the company’s substantiation, it will report the company to the FTC and/or the FDA and issue a negative press release. Class action attorneys monitor these press releases, looking for new class-action case opportunities.
• Class Action – A lawsuit where there are numerous plaintiffs, represented by a member of the group. Because of the number of plaintiffs, class action lawsuits can have some of the highest monetary awards. A core objective of our legal counsel is to help businesses avoid such lawsuits.

How an FDA/FTC Attorney Can Help

FTC regulation of marketing and labeling of foods, cosmetics, dietary supplements, OTC drugs, and medical devices can be challenging. You do not have to figure it all out on your own. An attorney experienced with the FDA, the FTC, and the NAD can help you before or after you have an advertising problem. We can represent you if you are facing FTC and NAD action. Bill Senior and Rick D. Quinn have decades of experience achieving FDA results for businesses, including handling issues involving the FTC. We are solutions-focused. Among other things, our FDA/FTC attorneys will help you and your business proactively build a compliant advertising strategy that reduces enforcement risk. Here is what our FTC compliance team can do:

• Conduct a comprehensive, confidential review of your website, advertising, and marketing materials.
• Review your product claims for potential FTC red flags before they are published.
• Assess your scientific substantiation and help you build substantiation files for key claims.
• Evaluate competitor NAD actions to predict areas of risk in your industry.
• Provide guidance on appropriate disclaimers and disclosures in digital and print advertising.
• Train your marketing team to understand FTC-compliant practices and avoid common liability traps.

The Bottom Line: We can help you avoid FTC and NAD issues before they happen by reviewing your claims, evaluating your claims substantiation, and helping you understand the risk associated with your marketing and advertising. Taking a proactive approach can save you money: our goal is to catch the risk before the regulators do so that our clients can avoid the time, cost, and stress of litigation. We have handled FTC/NAD-related cases for over a decade. We have also reviewed hundreds of labels with thousands of claims, and websites for foods, drugs, dietary supplements, medical devices, and cosmetics. Let us be your advocates and advisors.