Nutritional supplements (also known as “nutraceuticals”) refer to dietary or herbal supplements that contain products derived from food and natural sources. Popular types of supplements include, but are not limited to, weight loss and weight management supplements, memory and focus enhancers, and sports nutrition supplements.
Nutritional supplements are separate and apart from pharmaceuticals and are regulated by the FDA less stringently than conventional food and drug products. Regardless, the FDA is charged with taking action against any unsafe product on the market, and the FTC has taken action against supplement companies for misleading consumers about the product and its benefits. The advertising, labeling, and scientific substantiation requirements for supplements are complex and frequently change in small but important ways through court cases and amendments to existing law. In addition, many states have their own regulatory framework for nutraceuticals, which are based on FDA regulations, but applied differently. Accordingly, it is important for those engaged in the sale or promotion of supplements to obtain legal review of and advice on their product and marketing materials.
Our knowledge of FDA and FTC regulations and our years of experience representing internet marketers are of great benefit to our clients marketing nutraceuticals online.
Our knowledge of FDA and FTC regulations and our years of experience representing internet marketers are of great benefit to our clients marketing their products online.
Kronenberger Rosenfeld has ample experience advising clients in the supplements industry, including in the following areas:
The sale of nutraceuticals touches on both the FTC Act and the FDA’s Dietary Supplement Health and Education Act of 1994 (DSHEA). Determining which Act applies in certain circumstances can be difficult. Our firm regularly navigates this constantly-changing landscape. Among other services, we often review clients’ products and advertising materials for compliance with FTC guidelines and FDA regulations, and we provide counsel on how to achieve and maintain compliance. Where applicable, we advise clients on any modifications that need to be made to the product to stay within exceptions to the FDA regulations regarding dietary supplements. We stay apprised of recent developments in the law, including “trends” in FTC and FDA litigation regarding categorical subsets within the vast array of nutraceuticals. Our work helping clients achieve and maintain compliance avoids not only unwanted and costly government investigation, but potential consumer class action lawsuits as well.
One of the primary tenets to be considered by any nutraceutical merchant is the claims about the product made to existing and potential consumers. Under the law, all such claims must be backed by peer-reviewed scientific studies published in reputable journals. Many advertisers and resellers rely on the manufacturer to ensure this requirement is met without doing any follow-up research of their own to ensure it is sufficient under the law. Another common mistake is gross exaggeration of the findings in these studies—often by affiliate advertisers or others that do not understand the legal risks involved. To avoid such pitfalls and the resulting liability, Kronenberger Rosenfeld reviews the product, the product claims, and the relevant studies for regulatory compliance. In addition, we draft and/or review advertising agreements with third parties to ensure that (1) only approved product claims and advertising content may be used and (2) use of unapproved content shifts legal liability to the third party.
Supplements are often sold in bulk or on a subscription plan to ensure a continuing supply to the consumer. However, the enactment of the federal Restore Online Shoppers’ Confidence Act (ROSCA) and California's Automatic Renewal Law (ARL), as well as recent crackdowns by the FTC, have made the practice of “continuity” or “rebilling” a highly risky venture. We are familiar with and experienced in advising on ROSCA, the ARL, and the FTC’s requirements, and often review clients’ websites to ensure the necessary “clear and conspicuous” billing disclosures are made.
The most compelling endorsements of a product often come directly from those who have used the product. However, using consumer testimonials in advertising can lead to a wealth of legal problems, including right of privacy and copyright infringement claims, or investigation by the FTC. We provide our clients with the knowledge and forms necessary to ensure consumer testimonials are obtained and used in a legal manner.
Just as consumer testimonials help sell a product, a negative complaint can be incredibly detrimental, especially when it is posted in an online forum. We work with our clients to set up policies and procedures to avoid complaints, resolve consumer issues, and generally maintain a high approval rating. When needed, we act as liaisons with government authorities or entities such as the Better Business Bureau to resolve complaints initiated by consumers.
Unfortunately, we are also aware of an uptick in the use of false online complaints by a competitor to drive the client’s consumers to the competitor’s own product. We have experience litigating these matters to identify the source of the false complaints and hold the source accountable for the client’s resulting losses.
Even resellers of generic nutraceuticals invest substantial time and money developing the name of their product as well as the look and feel of their advertising and labeling. This intellectual property (IP) is valuable and worth protecting. We regularly file copyright and trademark applications for our clients and assist in managing their IP portfolios. When needed, we send Digital Millennium Copyright Act takedown notices and cease-and-desist letters to combat copyright and trademark infringement. We also have substantial experience litigating trademark infringement, copyright infringement, and cybersquatting disputes.
Online marketplaces managed by known retailers—such as the Amazon Marketplace—are growing in popularity for the sale of nutraceuticals due to their ability to reach new consumers and allow them to purchase the product through a familiar sales channel. However, trademark and copyright infringement is common on these websites as infringers capitalize on the client’s brand recognition by purporting to sell the client’s product, using the client’s product name and images, but mailing the consumer a different product entirely. Needless to say, in addition to infringement, this unlawful practice can result in an increase in consumer complaints and decrease in client’s sales. Tracking down infringers through marketplaces can be difficult, but our firm has been successful in this endeavor. We have developed a series of investigative procedures to document the activity, identify the wrongdoer, and hold them accountable, thereby protecting the clients’ IP, sales, and reputation.