In the midst of continued enforcement regarding coronavirus marketing, FDA sent a warning letter to NeuroXPF concerning advertising for its CBD products alleging that they can boost immune systems to help consumers avoid contracting the virus. Citing the need to take “urgent measures to protect consumers” in the midst of the coronavirus outbreak, FDA advised
FDA Updates Enforcement Discretion Policy For Gowns, Gloves, and Other Apparel
FDA took action earlier this week to relax regulatory standards for gowns, hoods, and surgeons’ and patient examination gloves during the pandemic. The policy applies to the following products:
Table 1
| Classification Regulation |
Device Type | Product Code6 |
Class |
| 21 CFR 878.4040 | Conductive Shoe and Shoe Cover | BWP | I (exempt) |
| 21 CFR 878.4040 | Operating-Room Shoes |
FDA Updates Enforcement Policy for Face Masks and Respirators
On March 25, FDA issued immediately effective guidance regarding its enforcement policy for face masks and respirators. In light of widespread reports of mask and respirator shortages, the purpose of the guidance is to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (N95 respirators)
FDA Releases Industry Guidance Regarding Adverse Event Reporting During COVID-19
On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary
FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and that made unsubstantiated, deceptive claims in violation of the FTC Act. In addition to the 11 joint warning letters
State AGs and the New Administration
As we discussed in recent interviews with Nutritional Outlook and Natural Products Insider, FTC enforcement against supplement companies is likely to evolve into something much more reasonable under the new administration. State attorney general activity, however, is likely to become more aggressive – or at least more widespread. State regulators may perceive a need
Dietary Supplement Advertising
Did you know Kelley Drye’s Advertising Law practice produces a newsletter, Dietary Supplement Advertising, to help marketers of dietary supplements stay out in front of regulatory challenges. Click here to access our Publication Sign Up and select Dietary Supplements to subscribe. Find contents from the latest issue below:
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STATE
DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug
On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research. This move is expected to expand and diversify the supply of marijuana for research use. Under the current policy, the only authorized marijuana manufacturer is the University of Mississippi, which operates under a contract with the
FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules
On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously released rules governing current good manufacturing practice, hazard analysis and risk-based preventive controls for human food and animal food (“the
The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts
On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S. Postal Inspection Service, the IRS, the Department of Defense, and the U.S. Anti-Doping Agency. The event was flush with provocative