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Last week, President Trump signed a presidential memorandum, “Addressing Misleading Direct-To-Consumer Prescription Drug Advertisements.” The memorandum invokes the U.S. Food and Drug Administration’s (FDA) authority to regulate prescription drug advertising, noting that the agency has historically required manufacturers, packers, or distributors to provide consumers with materially complete information regarding the benefits and risks of the advertised drug.

In the memorandum, Trump directs Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. to take “appropriate action” to ensure transparency and accuracy in direct-to-consumer drug advertising, including increasing the amount of information that must be disclosed regarding the risks associated with the drug. The Commissioner of Food and Drugs is also directed to take appropriate action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions.Continue Reading Prescription Drug Advertising Under Scrutiny: New FDA and HHS Enforcement Actions

Consider these six options for challenging your competitors’ advertising and marketing claims—each with its own advantages and disadvantages.
Continue Reading Event in Review: Why Can They Say That, but I Can’t? How to Challenge Your Competitors’ Advertising While Avoiding Being Targeted

Episode 2 of the Ad Law Tool Kit Show, “Marketing FDA-Regulated Products,” is now available. Listen here, or search for it in your favorite podcast player.

The Federal Drug Administration (FDA) regulates the marketing of a lot of things we use every day—dietary supplements, cosmetics, and medical devices. But their regulatory classification isn’t always clear, leading to confusion for marketers.

In this episode, I talk to Venable partner Todd Harrison about how marketers need to understand such regulations to avoid trouble, considering aspects like claims aligning with regulations, social media impact, and necessary FDA clearance for medical devices.Continue Reading Listen to Episode 2 of Venable’s Ad Law Tool Kit Show—“Marketing FDA-Regulated Products”

The COVID-19 crisis has spawned a new wave of predatory behavior toward consumers, with the marketing of coronavirus-related products and untested cures. Regulators have responded to these behaviors swiftly and in a variety of ways. Richard Cleland, assistant director – division of advertising practices at the Federal Trade Commission (FTC), and Venable attorneys Melissa Steinman and Kristen Klesh addressed the advertising enforcement trends stemming from the COVID-19 pandemic and offered their reflections on best practices for consumer protection.

How has the FTC addressed consumer complaints?

The FTC’s response to COVID-19-related violations has been a combination of education and enforcement. The agency recorded more than 130,000 complaints in approximately the first half of 2020; unsubstantiated health claims and health fraud are the main areas of concern. The FTC has issued more than 300 warning letters and has seen a high compliance rate (around 95%) with this course of action. These letters address claims that businesses are promoting the cure or treatment of COVID-19 through:

  • dietary supplements or treatment in medical or wellness clinics in the form of herbal teas, essential oils, vitamins, zinc, immunity boost IVs, chiropractic, homeopathic, other therapies, virus-killing “zappers,” and colloidal silver
  • anti-vaccine messaging

The FTC has also filed three federal court actions related to COVID-19 consumer fraud and the agency is conducting extensive consumer education campaigns related to health fraud and coronavirus scams. The FTC website examines various types of health and economic fraud related to the epidemic.Continue Reading Ad Law in the Age of COVID-19 and Regulatory Reactions

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

As COVID-19 becomes a more prevalent part of everyday life, federal and state regulators have made it clear that they will aggressively enforce consumer protection laws against companies that seek to take improper advantage of the COVID-19 pandemic.

In a March 26, 2020, statement, Federal Trade Commission Chairman Joe Simons strongly condemned businesses who engage in unfair and deceptive business practices during the COVID-19 pandemic. Chairman Simons stated that the FTC was working with federal and state law enforcers, consumer advocates, and business owners to protect consumers from companies who seek to take advantage of consumer fears regarding COVID-19. As we previously blogged, the FTC, along with the Food and Drug Administration, began taking action against these companies by issuing warning letters to seven sellers of unapproved or misbranded products which claimed that their products could treat or prevent COVID-19. In their respective statements regarding these warning letters, the FTC and FDA indicated that these warnings were only a first step and committed to aggressively pursuing companies who seek to take advantage of consumers during this national emergency. The FTC also published information about Coronavirus-related complaints from consumers, noting the significant number of Coronavirus-related complaints reported from consumers this year.Continue Reading Federal Trade Commission and State Regulators Issue Warnings to Companies that Deceptively Advertise COVID-19-Related Products and Services

Growing concern over the coronavirus (COVID-19) has seeped into the regulatory and legal world. Agencies and plaintiffs’ attorneys are targeting companies that claim their products can treat or prevent COVID-19. As people search for health products to counter the growing threat of coronavirus, companies should keep in mind that any advertising claims made must be substantiated. Health claims trying to trade on the panic caused by the virus will be closely monitored and pursued by law enforcement and the plaintiffs’ bar.

A few days ago, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) issued seven joint warning letters to companies making allegedly unapproved and unsupported advertising claims related to their products’ ability to treat or prevent the coronavirus. The letters state that any advertising claims trumpeting a product’s ability to treat COVID-19 “are not supported by competent and reliable scientific evidence” — which is required under the FTC Act.Continue Reading FTC, FDA, State AGs, and Class Action Lawsuit Clean Up Claims that Products Can Treat or Prevent Coronavirus

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

Two Executive Orders Continue Trump Administration Efforts to Restrain Agency Policymaking

Last week, President Trump signed two executive orders designed to limit the ability of federal agencies to make and enforce policy through the use of guidance documents. While this may seem like a mere technical issue, the ramifications could be significant.

A federal agency may issue a guidance document for a variety of reasons. Some agencies, such as the U.S. Food and Drug Administration (“FDA”), use it as the primary instrument for announcing and explaining significant policies. Many FDA guidance documents clarify agency positions regarding complex and ambiguous laws and regulations governing the broad range of companies it regulates. This includes manufacturers and marketers of food, dietary supplements, cosmetics, drugs and medical devices.

Some question whether agencies (including FDA) have gone too far. Agencies are supposed to promulgate a regulation when creating a new rule. In contrast, an agency may convey an interpretation of a currently existing rule through the issuance of a guidance document or other, less formal means. While it is often challenging to distinguish a new rule from an interpretation, the distinction has serious implications. The cost, time and effort required to publish a guidance document are far lower. Notably, a regulation may only be finalized after the agency has received and addressed all public comments. No such requirement exists for guidance documents.Continue Reading A New Challenge for FDA?