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 Consultant Food Services
Our FDA Consultant Food and Beverage Services are comprehensive, to help our clients develop products that are compliant with federal laws and regulations. From ingredient reviews to label reviews, FDA registration and marketing reviews, we have FDA Consultant – Food …
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 …
Cosmetic Products and the FDA
FDA Regulation of Cosmetics Products Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food …
FDA Imports: Tradeoff — Less Vigilance for More Diligence
The U.S. Food and Drug Administration (FDA) has found its ability to inspect and re-inspect all of the entities involved in food importing in a slow decline, resulting in delays for those dealing in FDA imports. Troubled by its inability …
District Court sides with Industry on Dietary Supplement Substantiation
A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. …
FDA Clears Device via De Novo Process
On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy. Marketed under the name the DigniCap® Cooling System, the …
FDA “Natural” Food Labeling
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 …
What’s in a Name? Everything, for “Standard” FDA Food Labeling
FDA Particular words mean everything to the U.S. Food and Drug Administration (FDA). It takes great pains and uses specific words to proclaim its position, and clarify what it names something, especially when it comes to setting a standard. Most …