Todd A. Harrison

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Todd Harrison, co-chair of Venable's FDA Group, guides clients through the myriad government regulations associated with food and drug labeling and marketing. Working extensively in the areas of food and dietary supplement safety, labeling, and advertising claims, Todd helps clients in the consumer products, drug and medical device, and dietary products industries comply with government regulations. He regularly achieves favorable results in defending clients against Federal Trade Commission (FTC) advertising complaints, enforcement actions, and prosecutions, and overcoming competitor challenges in courts and other fora.

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Join us as we offer a sneak peek into select chapters from the newly released 14th edition of Venable’s Advertising Law Tool Kit, which helps marketing teams navigate their organization’s legal risk. Want more? Click here to download the entire Tool Kit.

Advertising Claims Substantiation

Objective advertising claims must be supported by prior substantiation. These claims—whether express or implied—generally concern measurable or otherwise verifiable attributes of a dietary supplement, food, device, or cosmetic. When an advertisement includes such claims, marketers must have a “reasonable basis” for them. As a general guideline, a reasonable basis means possessing the level and type of substantiation that experts in the relevant field would consider adequate to support the claim. Extra caution is required for health-related claims, including structure/function claims, or other assertions that consumers cannot readily assess for themselves (such as statements that a product “supports normal cholesterol levels”) which must be supported by competent and reliable scientific evidence. The amount and type of evidence needed will depend on the nature of the claim and what experts in the field would deem appropriate. This is a flexible standard and does not necessarily require a product-specific clinical study

Continue Reading Inside the Ad Law Tool Kit: Advertising Claim Substantiation

The Federal Trade Commission (FTC) issued warning letters to ten companies for alleged deceptive review practices, indicating its intent to step up enforcement of its relatively new Consumer Review Rule (16 C.F.R. Part 465) (“the Rule”).

The warning letters have implications for all direct-to-consumer sellers. For industries that rely heavily on consumer reviews, including dietary supplement, health and wellness, and beauty/personal care companies, the FTC’s action is particularly significant. These industries often market using consumer reviews, influencer endorsements, testimonials, and before-and-after content—practices that now carry increased regulatory risk. While the warning letters do not constitute formal findings of liability, they underscore the FTC’s readiness to pursue civil penalties of up to $53,088 per violation against the recipients (an amount that will likely increase in 2026 with inflation-adjusted civil penalties).

Continue Reading FTC Signals Heightened Enforcement of New Consumer Review Rule

On March 10, the Department of Justice (DOJ) moved to drop a lawsuit filed on behalf of the Federal Trade Commission (FTC) against Xlear, which marketed a line of over-the-counter saline nasal spray products touted to treat and prevent COVID-19 and similar viruses.

The DOJ filed the lawsuit in October 2021, alleging that Xlear violated the FTC Act and the COVID-19 Consumer Protection Act by disseminating claims that the FTC argued were false and misleading.

Despite a July 2020 warning from the FTC that the company’s COVID-19-related claims violated the FTC Act, Xlear continued to make various COVID-19 treatment and prevention claims, including that in vitro studies conclude that their sinus “nasal spray is ‘an effective…and replicable means to deactivate SARS-CoV-2…to an undetectable amount of infectious virus.'”

Continue Reading DOJ Dismisses Lawsuit Over COVID Nasal Spray False Advertising

Recent trends indicate that consumers and the U.S. government are paying more attention to where products are sourced from.  

The Biden administration, for example, has made efforts to raise federal procurement standards for products “Made in America.” Specifically, the administration in March announced a final rule that outlined gradual increases to the “Made in America” requirement. As of October 25, the rule requires that federally procured products under the Buy American Act must have 60% of the value of their component parts manufactured in the United States. Under the prior rules, the Buy American Act only required that products contain 55% component parts manufactured in America in order to qualify for federal procurement. The threshold will further increase to 65% in 2024 and 75% in 2029.

Continue Reading An Update to “Made in USA” for Federally Procured Products and FTC’s “Made in USA”

An increasing number of celebrities and social media personalities are endorsing the use of cannabidiol (CBD) products through social media. Many of these “influencers,” however, fail to take into account and comply with the complex regulatory environment surrounding CBD advertisements, which can have consequences for CBD companies themselves. In the United States, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) both limit the use of certain language in CBD endorsements. As these advertisements attempt to reach the broadest possible audience, possible violations are especially noticeable to regulators, who have stepped up their enforcement efforts in this area.

What is CBD?

With the passage of the 2018 U.S. Farm Bill, hemp-based CBD products were removed from the Drug Enforcement Administration’s list of scheduled substances, thereby decriminalizing the possession of such CBD products. The Farm Bill defines hemp as a strain of the Cannabis sativa plant species that does not contain more than 0.3% of the psychoactive component tetrahydrocannabinol (THC). Instead, hemp has significantly higher concentrations of CBD. The legalization of recreational and medicinal marijuana in certain states refers to the cannabis plant containing high levels of THC, which may also contain some CBD. Certain states, such as California, have stringent requirements regarding advertising cannabis products, but these rules do not apply to hemp-based CBD products.Continue Reading CBD Advertisements: What CBD Companies and Celebrity Influencers Need to Know

Agency Denies Industry Petition and Publishes Revised Draft Guidance

The U.S. Food and Drug Administration (FDA) appears set to ramp up enforcement efforts against companies selling homeopathic products. Since 1988, FDA’s enforcement decisions have been made within the framework of Compliance Policy Guide (CPG) § 400.400. Under this policy, the agency generally limited enforcement actions to products that were either inappropriately labeled or manufactured in violation of good manufacturing practice (GMP) regulations. Publication of the new draft guidance document, which officially withdraws CPG 400.400, is the latest signal that the regulatory landscape is changing – perhaps dramatically.

The agency first revealed a new attitude toward homeopathic drugs with the issuance of a draft guidance in December 2017, which laid out a new “risk-based” model of enforcement that would guide agency decisions on homeopathic products. As we previously reported, this effectively rolled back the permissive framework of the CPG, although the agency noted that the CPG would not be withdrawn until the draft guidance is finalized. Not surprisingly, the homeopathic industry pushed back. One group (Americans for Homeopathy Choice) filed a petition urging the retention of the Compliance Policy Guide and the preservation of FDA’s pre-guidance homeopathy framework.Continue Reading FDA Puts Homeopathic Industry on Notice – No More Lax Enforcement

With the ink on the president’s signature barely dry, the commissioner of the U.S. Food and Drug Administration (FDA) – Dr. Scott Gottlieb – issued a statement letting everyone know that the agency is aware of the implications of the Agriculture Improvement Act of 2018 (a/k/a the Farm Bill). As we reported last month, CBD derived from hemp may not be “marijuana” any longer, but the laws that the FDA enforces continue to prohibit (at least, in the FDA’s view) the manufacture and distribution of foods and dietary supplements containing CBD. Dr. Gottlieb took this opportunity to reiterate the agency’s position, noting that “it’s unlawful under the [Federal Food, Drug and Cosmetic Act] to introduce food containing CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”

The commissioner also indicated, however, that the agency will initiate a process for reexamining current policy, stating:Continue Reading CBD Update: The FDA Commissioner Cannot Ignore the Buzz – But Is Further Deregulation on the Horizon?

orange splashWhich foods deserve to be labeled as “healthy?” The FDA considered this question at a public meeting on March 9th.

This public meeting was the latest stop on the FDA’s journey to redefine the term “healthy” in food labeling. The journey started almost 2 years ago in March 2015 when KIND received a warning letter from the FDA stating that many of its products labeled “healthy” were misbranded. KIND’s products, of which nuts are a primary ingredient, exceeded the “low saturated fat” threshold required to make the nutrient content claim “healthy” under FDA regulations.Continue Reading Process to Redefine “Healthy” Moves Forward with FDA Public Meeting

Marketers of consumer products, including foods, beverages, dietary supplements, OTC drugs, and cosmetics, should be evaluating their products, including product packaging, for the presence of bisphenol A (BPA) without delay. On May 12, 2016, the one-year grace period permitted by California’s Office of Environmental Health Hazard Assessment (OEHHA) ends, and companies whose products expose California consumers to BPA must provide a Proposition 65 (Prop 65) reproductive toxicity warning to those consumers.

Importantly, California has not yet established a maximum allowable dose level (MADL) (i.e., a safe harbor level) for BPA, so a product that exposes consumers to any amount of BPA will be required to carry a warning for reproductive toxicity in females unless the company marketing the product has established an MADL in compliance with California regulations. As a reminder, Proposition 65 requires “clear and reasonable” warnings prior to exposure.Continue Reading Have You Evaluated Your Products and Product Packaging for BPA Content? A Prop 65 Warning is Required Beginning in May