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Consumer Product Matters A product safety and consumer related regulation and litigation blog

Tag Archives: FDA Final Rule

FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress

Posted in Federal Regulations, Food & Drug Administration (FDA), Tobacco Products, U.S. Congress

As we’ve previously written about, 2016 represented a regulatory sea change for manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS), who became subject to FDA oversight and requirements under the May 2016 Deeming Rule for tobacco products. In Monday’s Federal Register, FDA issued a final rule to exclude products derived… Continue Reading

E-Cigarette Makers Contending with New CPSC and FDA Regulations

Posted in Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Federal Regulations, Food & Drug Administration (FDA)

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other interested parties, including dozens of plaintiffs in lawsuits stemming from battery explosions and other injuries.  Newly enacted Federal requirements for ENDS and their components and parts… Continue Reading

The Last Set of Major FSMA Regulations Are Done!

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Supply Chain Risk Management

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of FSMA (our posts on the… Continue Reading

A Decade Later, Rules for the Sanitary Transportation of Food Finally Finalized by FDA

Posted in Distributors, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Retailer Product Safety, Supply Chain Risk Management

Last week, FDA finalized new food safety regulations seeking to ensure the sanitary transport of human and animal food, as required under the Food Safety Modernization Act (FSMA). The final Sanitary Transportation of Human and Animal Food Rule will affect shippers, loaders, carriers, and receivers of food transported by rail or motor vehicle in the… Continue Reading

FDA Defines “Gluten-Free:” Consumers and Manufacturers Both Win

Posted in Food & Drug Administration (FDA), Food and Beverage, Litigation, Manufacturer Product Safety

On August 5, 2013 the FDA issued its final rule on the voluntary labeling of food gluten-free. This is good news for both consumers and manufacturers. The rule, promulgated under the Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”), provides that food can be labeled “gluten-free,“ “no gluten,” “free of gluten,” or “without… Continue Reading