FDA Animal Regulation Requirements

FDA Animal Regulation Requirements

 

The manufacture and distribution of food additives and drugs that are given to animals is regulated by the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM). CVM is responsible for regulating drugs, devices, and food additives given not only to pets (companion animals), but also animals for human consumption, such as poultry, cattle, swine, chickens, turkeys, and others.

Our firm can assist you with all aspects of veterinary products regulation, manufacture, approval, and marketing.We can guide you through the registration and listing of drug establishments, medicated feed mill licenses, abbreviated new animal drug applications (ANADA), new animal drug applications, product labeling, claims, and promotion, navigation of genetically engineered animal regulations, approval of drugs for aquaculture, import and export of veterinary products, response to regulatory enforcement actions, warning letter response, and assisting with compliance of parallel state laws and regulations.

Labeling Review:FDA regulations require that certain information appear on food and dietary supplement labels, such as statement of identity, net quantity of contents, and ingredient information. The information must also be formatted in accordance with the regulations. By law, companies may make three types of claims on their products: health claims,structure/function claims, and nutrient content claims. Different requirements generally apply to each type of claim. Unless specifically allowed by regulation, a company is prohibited from making labeling claims that imply its food products diagnose, cure, mitigate or prevent disease.

Our firm conducts label and ingredient reviews for all functional foods and dietary supplements in accordance with FDA regulations. This includes review of structure/function claim, health claims, and nutrient content claims, as well as the formatting of the labeling.

The firm also can help you file a 30-Day Structure/Function Claim Notification with the FDA for your dietary supplements.

Advertising Review: Our firm provides advertising counseling for your animal products to ensure conformance with regards to third-party testimonials and websites, social media, claim substantiation (amount of scientific support) and various other Federal Trade Commission (FTC) regulations.

Facility Registration and Prior Import Notice: The FDA requires facilities that manufacture, process, pack or store foods and dietary supplements marketed in the U.S. file registrations with FDA. Under the Bioterrorism Act, foreign food and dietary supplement manufacturers must also register with the FDA and provide prior notice of import before their products arrive in the U.S. We can assist you with registration and  filing Prior Import Notices and will work closely with your Customs broker to ensure compliance with the Bioterrorism Act and Prior Import Notice requirements.

Export Certificates: Struggling to determine whether you need a n Export Certificate to  Foreign Governments, Certificate of Exportability, or Certificate of a Pharmaceutical Product? Not sure whether to use Form 3613a or 3613b? We can help you apply for the right export certificate for your animal food, drug, or medical device. Our firm offers the experience to make the process simple and straightforward, eliminating confusion on forms and what attachments to include. Whether your already selling the product in the US or only looking to export we can help.

Warning Letter & Border Detention Assistance: If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to “fix” a deficiency so that you wouldn’t have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast. We can help you respond and take appropriate actions so you can get back to business. Contact the firm as soon as possible for a free initial consultation.

Drug and Dietary Supplements: The FDA requires all food products to solely be offer for taste, aroma, and nutrition. There is no dietary supplement category for animals like there is for humans. If a food product’s claims go too far, it may be classified as a new drug. We can help you assess a nutrtional supplement and guide you through the process to enter the market.

 

Contact us to learn more about our animal regulatory practice.