Food

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 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 significant 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 to avoid suspension of your facility registration and delays upon importation.

Our 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.

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, and
• You are advised of color additive rules and compliance with certification requirements.
• You are meeting registration requirements
• If you act as the Foreign Supplier Verification Program (FSVP) Importer, you have a FSVP plan in place

Foreign Supplier Verification Program (FSVP) Services

The U.S. FDA Food Safety Modernization Act (FSMA) provided the FDA greater authority to prevent unsafe food from entering the U.S. and increased the FDA’s enforcement powers. The FSMA also gave FDA the power to hold imported foods to the same standards as domestic foods and to suspend a food facilities registration for non-compliance.

One of the many requirements under FSMA is that food importers (or their agents) must develop a Foreign Supplier Verification Program (FSVP) to provide adequate assurances that their foreign suppliers are producing compliant food. Importers covered by the FSVP regulation must put in place foreign supplier verification programs (FSVPs) to verify that their foreign suppliers are producing food using processes and procedures that provide the same level of public health protection as those required under the preventive controls (for human or animal food) or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling (21 CFR 1.502(a)).

For more information on FDA requirements visit FDA’s website on importing food here.

A qualified individual must develop your FSVP. This qualified individual must have the education, training, or experience (or combination thereof) necessary to perform the activity, and must be able to read and understand the language of any records reviewed in performing an activity.

A Preventive Controls Qualified Individual (PCQI) is a person that has successfully completed adequate training or is otherwise qualified through job experience to develop and implement a food safety plan. A PCQI manages important aspects of the food safety program and ensures that preventive controls are effective and proper records are maintained. Diaz Trade Law has trained PCQI specialists that are qualified to develop, review, and/or implement your FSVP.

FDA is actively performing FSVP inspections. Many inspections are resulting in warning letters as the importers do not have the required FSVP in place. Diaz Trade Law can assist you in preparing for your FDA inspection, working to develop, review, and/or implement an effective FSVP so that you are prepared for your FDA inspection.

Want more information? Check out our webinar: “Importing Food in Compliance with U.S. FDA and Surviving a FSVP Audit.”

Want to learn more?

• Food Importers: How to Import Food Compliantly & Survive a FSVP Audit
• FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations

Cosmetics

Dietary Supplements

The FDA regulates both dietary ingredients and finished dietary supplement products. These products are regulated under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations.

Our team ensures that your dietary supplement products meet all requirements under FDA regulations.

Want to learn more?

• Dietary Supplement Labeling Do’s and Don’ts

Over the Counter (OTC) Drugs

Alcohol

Medical Devices

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, depending on the Class of the medical device you are importing, the submission types will differ.

• 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.

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment. Additionally, some medical devices require premarket submissions depending on use and classification. At the time of importation, the FDA will verify that these requirements are met.

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.

Want to learn more?

• Importing Medical Devices in Compliance with the U.S. FDA
• Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?
• Don’t Let FDA Target Your Medical Device Company
• Tips on FDA’s Medical Device Registration Process
• Does Your Medical Device Have a Unique Device Identification (UDI)?
• What Do Contact Lenses, Dental Floss, and Pacemakers Have in Common?
• FDA Launches New Webpage to Promote Use of Symbols in Labeling of Medical Device
• Medical Device Registration Made Easy!