DIAZ Trade Law

Customs & International Trade Law Expert

U.S. Food and Drug Administration (FDA)

If you import a food, cosmetic, dietary supplement, medical device, over the counter drug or alcohol, your merchandise is regulated by the FDA. Diaz Trade Law provides a full array of FDA services tailored to both domestic and foreign companies to help you ensure you meet FDA requirements prior to importation.
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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.

Call 305-456-3830 or email info@diaztradelaw.com.

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 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.

Dietary Supplements


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.

Cosmetics

The FDA regulates cosmetics; however, the FDA’s legal authority over cosmetics is different from other products regulated, such as drugs, biologics, and medical devices. Under FDA’s Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics must not be “adulterated” or “misbranded.” For example, they must be safe for consumers when used as directed in their labelling or under customary conditions of use, and they must be properly labelled and not mislead consumers. Companies and individuals who market cosmetics have a legal responsibility for the safety and labelling of their products.

The FDA strictly regulates the ingredients and labelling of cosmetics. Diaz Trade Law performs an in depth label and ingredients review to assist companies in complying with the FDA’s extensive requirements.
We provides the following services:
  • Importing
  • 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.

Although cosmetics are not subject to any premarket approval from the FDA, the FDA recommends that firms participate in FDA’s Voluntary Cosmetic Registration Program (VCRP). The VCRP is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US. Through the VCRP, Diaz Trade Law submits Cosmetic Product Ingredient Statement (CPIS) filings and Registration of Cosmetic Product Establishments.
Diaz Trade Law provides Labelling and Claim Review and VCRP Registration and Ingredient Statement filing on behalf of cosmetic companies.
Important FDA Regulations Regarding Cosmetics
21 C.F.R. Parts 700-799

Over the Counter (OTC) Drugs

There are many FDA regulations that apply to drugs; these regulations are substantially different from the ones that regulate food and cosmetics. Under the Federal Food Drug and Cosmetic Act (FDCA), “drugs” are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”. Drugs are also described as “articles intended to affect the structure or any function of the body of man or other animals.” The definition of drugs used by the FDA looks at the intended use of the product, rather than the nature of the product. Therefore, any ingested or topical product that is marketed as a beneficial drug-like product will be regulated by the FDA as a drug.

The regulations that are imposed on drugs vary according to the class of drug. All drug labels must comply with the FDA’s strict regulations. The FDA regularly stops and examines drug shipments. Importations of drug products are checked for valid FDA drug establishment registration and drug listing numbers.

Diaz Trade Law will review your drug label for compliance with FDA regulations and assist with the FDA drug establishment registration and drug listing requirements.

Medical Devices


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.

Important Regulations for Medical Devices

Alcohol

Alcoholic beverage imports, distribution, storage and wholesaling are regulated in the U.S. primarily by Alcohol and Tobacco Tax and Trade Bureau (TTB). The TTB issues permits for companies to operate as an importer and wholesaler of alcoholic beverages in the U.S. TTB also strictly regulates the labels that appear on all alcoholic beverages. Each state and municipality has additional laws that may further regulate alcoholic beverage distribution, importation, storage, wholesale and retail operations. Also, each state and municipality may issue its own permit to allow businesses to perform these business operations.

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.

Our team assists with all TTB permits, and label reviews and assists in completing the COLA.

Alcohol and Tobacco Tax and Trade Bureau (TTB) Useful Links:

Dealing with FDA Enforcement Issues

What happens if you do Not Meet FDA Requirements Prior to Importation?
Examples of enforcement actions by the FDA may include Notices of FDA Action detaining goods upon entry, being placed on the FDA’s Import Alert (“red light”) list, warning letters, FDA’s inspections, and liquidated damages claims issued by U.S. Customs and Border Protection (“CBP”) for an underlying FDA violation.

Call 305-456-3830 or email info@diaztradelaw.com.

CONTACT DIAZ TRADE LAW

Call 305-456-3830

Note: If you have documents you would like us to review, please email docs@DiazTradeLaw.com