On November 30, FDA’s Center for Veterinary Medicine (CVM) released a draft guidance, “Using Relative Supersaturation to Support ‘Urinary Tract Health’ Claims for Adult Maintenance Cat Food,” to provide recommendations for how pet food companies manufacturers can use relative supersaturation (RSS) methodology to support urinary …
Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) …
For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table. Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. § 180.30, its interim authorization of the use of …
On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. More specifically, the proposed rule, if finalized, would: Amend 21 C.F.R. § 1.281(b)(10) to require that prior …
On August 7, 2023, a little less than five months before the registration and listing of cosmetic product facilities and products becomes mandatory, FDA announced the availability of a draft guidance regarding the new facility registration and product listing requirements under the Modernization of Cosmetic …
On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, was introduced. This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act), is an effort to create an approval process for ingredients …
FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. As anyone familiar …
On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG reflects the three major laws and regulations that …
For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. At the federal level, the Center of Veterinary Medicine (CVM) …
On April 13, the Federal Trade Commission (“FTC” or “Commission”) issued a press release that it had sent letters to “almost 700 marketing companies that they could face civil penalties if they can’t back up their product claims.” FTC indicates that the notices were sent to companies …
Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. Though not …
On Dec. 20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). FTC staff prepared the new Guidance to update and replace Dietary Supplements: An Advertising Guide for Industry, issued in 1998 (“1998 Guidance”). The new Guidance provides the first update …
On December 23, 2022, when many of us were distracted by the cold weather, Congress passed the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act of 2023. FDORA includes, as subtitle E, the Modernization of Cosmetics Regulation …
On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. As we reported previously, here, and here, as a result of …
Early Nov. 2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the …
