Receiving an FDA warning letter is stressful and urgent for any company operating in regulated spaces. These letters point to specific compliance gaps and, if left unaddressed, can lead to costly enforcement. This guide lays out a clear, practical path …
The regulatory framework for dietary supplement claims is set by the FDA to protect consumers and promote truthful marketing. This article explains the differences among structure/function claims, health claims, and disease claims, and outlines the definitions, regulatory requirements, and business …
FDA compliance services help companies operating in food, drug, and cosmetic markets navigate federal rules and reduce regulatory risk. These services make sure products meet safety and performance expectations and help protect public health. With regulators increasing scrutiny, a clear …
Navigating FDA requirements is essential for companies that make or sell food, dietary supplements, cosmetics, or over-the-counter (OTC) drugs. Meeting those rules protects consumers and preserves trust in the marketplace. This guide breaks down the core obligations for each product …
On March 27, 2023, the U.S. Food & Drug Administration (FDA) announced that it will no longer be accepting submissions to its Voluntary Cosmetic Registration Program (VCRP). Starting in 1972, VCRP has been the only type of submission that is …
On December 20, 2019, changes to the minimum tobacco-sale age were signed into law, increasing the federal minimum age for tobacco sales from 18 to 21. The U.S. Food & Drug Administration (“FDA”), the Agency responsible for enforcing age-related sale …
On September 9, 2019, the U.S. Food & Drug Administration (FDA) issued a Warning Letter to JUUL Labs, Inc. (JUUL), in connection with the marketing of its exceedingly popular e-cigarette products. According to the FDA, JUUL is alleged to have …
On February 11, 2019, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease” (“FDA Warning”). Found here, the FDA Warning notifies …
In response to growing concerns over sesame allergies, the U.S. Food & Drug Administration (“FDA”) is reportedly considering adding sesame to the list of major food allergens. Since the enactment of the Food Allergen Labeling and Consumer Protection Act of …
On October 5, 2018, the internet went abuzz with news that La Croix, a refreshing favorite to millennials and soccer moms alike, was targeted with a high-profile class action suit. Arguing that La Croix’s labeling failed to live up to …