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

By Mokkie (Own work) [CC BY-SA 3.0], via Wikimedia Commons
Countless Cosmetic and Dietary Supplement Products Implicated

Effective Friday, December 4, the California Office of Environmental Health Hazard Assessment (OEHHA) listed Aloe vera (non-decolorized whole leaf extract) and goldenseal root powder as carcinogens on its list of

This week, FDA finally published a December 2012 warning letter on its website, showcasing its first-ever enforcement action based on a company’s social media activity.  In the letter, FDA interprets a dietary supplement company “liking” a consumer testimonial posted to its Facebook website as an implied endorsement of the underlying claim content.

The offending post,