All products regulated by the Food and Drug Administration (FDA) must meet the same requirements, whether imported from abroad or produced domestically. Contact the The Law Office of Mahmud Yennes, PLLC for assistance with FDA Compliance and Regulatory Guidance Services.
Regulatory Guidance Services
The FDA regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm.
Contact our firm for
- Removal from a red list
- Addition to a green list of an Import Alert
- Holds and Detention
- And Recalls
The FDA regulates the content and form of labels for industries in food, cosmetics, dietary supplements, devices and drugs. The FDA reviews labels for compliance and ensure all under review must meet the basic requirements to be in the market. Contact the The Law Office of Mahmud Yennes, PLLC for assistance with FDA Compliance and Regulatory Guidance Services.
Elements and requirements by commodities differ, our firm will assess and review your specific product by outlined regulations to ensure compliance. Some of these include (but are not limited to) the following:
- OTC Drugs
- Dietary Supplements
- OTC Devices
The FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or the Agency’s regulations is by an FDA-issued warning letter.
The FDA finds that a manufacturer has significantly violated the FDA regulations, the FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a time frame for the company to inform the FDA of its plans for correction. the FDA then checks to ensure that the company’s corrections are adequate. Matters described in the FDA warning letters may have been subject to subsequent interaction between the FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.
There are many types, some examples include:
- Tobacco Retail Warning Letters
- Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies)