How Can Diaz Trade Law Help My Company Meet FDA Requirements?
Assistance includes pre-compliance (assisting to successfully bring your product to market in the U.S.) as well as assistance in successfully navigating FDA enforcement actions. We provide FDA compliance assistance for food, dietary supplements and alcoholic beverages; over-the-counter drugs; cosmetic and medical device companies. The purpose of “Pre-Compliance” assistance is to assure your product is marketable in the U.S., prior to entry, to assist in preventing costly and timely delays. Pre-compliance services for food products include product and label review, U.S. Agent services for foreign food facilities registration with the FDA, and potential registrations with the FDA.
Navigating FDA Enforcement
FDA is the federal agency that is responsible for overseeing most of the U.S. food supply. FDA is responsible for protecting the public health by ensuring the safety and security of our nation’s food supply; this is a vital part of FDA’s mission and a primary task of FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
The U.S. FDA Food Safety Modernization Act (“FSMA”) gives the FDA greater authority to prevent food safety problems and concerns, and increases the agency’s enforcement powers in order to achieve higher rates of compliance with the law’s requirements. The FSMA also gives FDA new powers to hold imported foods to the same standards as domestic foods and to suspend food facility registration numbers for non-compliance.
The FDA has several requirements for domestic and international facilities. A major requirement is that all domestic and foreign facilities that manufacture, process, pack, or hold food or beverages for importation or distribution in the U.S. update their registration with the FDA biennially. This must be followed in order to avoid suspension of your facility registration and delays upon importation.
The FDA requires that foods sold in the U.S. are safe, wholesome and properly labelled. This includes foods produced domestically, as well as imported foods. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA’s jurisdiction.
The FDA requires that your food, beverage and/or dietary supplement label is accurate and in compliance with FDA’s rules and regulations. The FDA does not pre-approve labels.
Our team ensures that:
- Food and beverage labels comply with FDA’s laws and regulations,
- All required nutrition and ingredient labeling requirements are included,
- Layout and design restrictions are met
- You are advised of any non-compliant claims on your product,
- You are advised of color additive rules and compliance with certification requirements.
- Review your product label,
- Determine if any drug claims appear on your product,
- Review the FDA’s Code of Federal Regulations (21 C.F.R.)
- Review applicable Federal Register Notices
- Review the VCRP Cosmetic Ingredient Dictionary
- Review relevant Guidance Documents
- Review the U.S. FDA Labelling Manual, as well as
- Applicable Warning Letters and Import Alerts issued by U.S.
Over the Counter (OTC) Drugs
How Can Diaz Trade Law Help you Import Alcohol?
To import alcohol into the U.S. you must meet several requirements:
- Complete an Importers Basic Permit with the TTB
- Depending on your business model, complete a Wholesalers Basic Permit with the TTB
- Obtain a TTB-issued Certificate of Label Approval (COLA) for each unique product/label.
- Alcohol is treated as a food by the U.S. FDA, therefore you must also register as a food facility under FDA’s Food Facility Registration before importing or distributing alcoholic beverages in the U.S.
All importations of medical devices must comply with vast FDA regulations. FDA defines a “medical device” under the Food Drug and Cosmetic Act (FD&CA) as an instrument, machines, implants, in vitro reagents, and similar or related articles, including component parts or accessories which are:
- 1. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
- 2. intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Medical devices fall into one of three classes.
- Class 1 medical devices are those with the lowest level of risk associated with them. If a Class 1 medical device failed or became defective, there would be no significant injury or harm to the patient or user.
- Class 2 medical devices carry greater risk. If a Class 2 medical device failed or became defective, there would be a risk that the patient or the user could be injured or harmed. Typically a 510(k) application is required. To obtain 510(k) clearance, Diaz Trade Law assists in filing an application to the FDA including scientific and technical information proving to the FDA that your medical device is “substantially equivalent” to a device already legally marketed in the United States.
- Class 3 medical devices carry the greatest risk. If a Class 3 medical device failed or became defective, there would be a risk of serious injury or death to the patient or the user. Typically a Pre-Market Approval (PMA) is required.
Diaz Trade Law performs the following services for medical device products:
- Label reviews
- Product assessments – to assure you correctly identify your product code and device class; and in our assessment we advise you of the regulatory requirements necessary to import your medical device.
- Importer of Record (IOR) Registration
- Manufacturer Registration
- Device Listing
- Premarket Notification (510(k)). If a 510(k) submission is necessary, we assist with the process and submission.
CONTACT DIAZ TRADE LAW
Note: If you have documents you would like us to review, please email docs@DiazTradeLaw.com