Co-Authored by Sharath Patil
Background on Securing Information Technology & Communications Supply Chains
Co-Authored by Sharath Patil
Background on Regulatory Review
U.S. federal laws come from a wide array of sources. They are generally organized under the following order of authority: 1) the U.S. constitution, 2) statutes passed by Congress, 3) treaties ratified by Congress, 4) case law, 5) executive orders, 6) regulations, and 7) agency guidance. After Congress has provided a federal agency with a policy mandate, an agency is empowered to promulgate regulations to provide detailed and binding rules on those matters.
For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.
Co-Authored by Denise Calle
Chemence Inc., a glue maker, is once again in a sticky situation with The Federal Trade Commission (FTC) for allegedly making deceptive claims that its products are made in the United States. In a proposed Consent Order, Chemence agreed to pay $1.2 million for its violation of the FTC Act for violating a 2016 federal court order to cease deceptive marketing tactics, as well as mandated an annual compliance report. The FTC now seeks Public Comment on the proposed consent agreement. The comment period closes on February 8, 2021. Thereafter, FTC will decide whether it should withdraw from the agreement or make it final and force Chemence to pay the $1.2 million penalty.