On February 11, 2019, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease” (“FDA Warning”). Found here, the FDA Warning notifies …
FDA Warning Issued to Fraudulent and Unapproved Flu Products
On March 2, 2018, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA warns of fraudulent and unapproved flu products (“FDA Warning”). Found here, the FDA Warning is aimed at notifying the public of …
Sample Response to FDA Tobacco Warning Letter
No One-Size-Fits-All Approach, No Sample Response to a FDA Tobacco Warning Letter Getting a FDA Warning Letter for your tobacco business can be confusing. Responding to a FDA Tobacco Warning Letter can be even more confusing and time-consuming for a …
FDA Untitled Letters: FDA Warnings with a Twist
The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA Warning Letters. Referred to as FDA Untitled Letters, these letters must be taken seriously, as the terms of FDA Untitled …
FDA Regulation of Aromatherapy and Essential Oil Products
Aromatherapy and essential oil products are becoming more popular by the day, and marketing these products in compliance with federal regulations must be a key consideration for marketers and distributors of these products. On September 22, 2014 the U.S. Food …
FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations
The U.S. Food and Drug Administration (FDA) has been ramping up their enforcement efforts against tobacco retailers in recent months for compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) by issuing countless tobacco warning letters in connection …
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. …
Court Issues Injunction after FDA Warning Letter Issues Persist
On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration (“FDA”) regulations and mandated standards (Current Good Manufacturing Practices …