On November 12, the U.S. Food & Drug Administration (“FDA”) announced that it is soliciting public comments on how the Agency should define the term “natural” and regulate its use in food labeling. The FDA has engaged the public’s input …
FDA Bans Trans Fats
FDA Issues Final Determination Concerning Partially Hydrogenated Oils The U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of …
Potential Changes to FDA Regulation of Homeopathic Drugs
On April 20, 2015 the Food and Drug Administration (FDA) heard testimony regarding homeopathic drugs and the Agency’s role in the regulation thereof. These two-day long hearings come after the FDA received over 1,500 public comments about the possibility of …
Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics
On March 31, 2015, Attorney Katherine Giannamore, of The Law Office of Katherine Giannamore, P.A., was interviewed by Ryan Nelson of “The Rose Sheet” about the challenges that companies face when marketing cosmetic products. “The Rose Sheet” is one of …
FDA Warns of Marketing Cosmetics with Drug Claims
The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) …
FDA Stops Company from Marketing Unapproved New Drugs
On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. …
FDA Guides on General Wellness and Low Risk Devices
On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health …
Overview of FDA’s Final Menu and Vending Labeling Rules
Menu and Vending Labeling Rules On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring that calorie counts be listed on menus and menu boards in certain restaurants and vending machines (menu and vending labeling …
USDA Organic Labeling
The United States Department of Agriculture (USDA) oversees the National Organic Program and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural …
FDA Food Allergen Labeling
When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, …