Food & Drug Administration

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

Regulatory

Food

The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. 21 U.S. Code § 321(f).

  1. Food Facility Registration – Under the Bioterrorism Act, the FDA requires that domestic and foreign facilities engaged in the manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility. Registration is done once, however, renewal is required biennially. The food facility registration number is provided to FDA and United States Customs and Border Protection in advance of imported food via “FDA prior notice.”Our firm can assist you with filing and renewing your food facility registration.
  2. United States Agent – Foreign food and beverage manufacturers who require a food facility registration are also required to appoint a United States agent. The FDA may contact the United States regarding the foreign manufacturer.Our firm frequently acts as a United States Agent to ensure compliance with FDA laws and regulations.
  3. Labeling – 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 Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements.Our firm handles labeling matters so that your products comply with FDA requirements.
  4. Canned Food – In addition to the other FDA requirements, commercial processors of shelf stable acidified foods and low-acid canned foods register each manufacturer and file scheduled processes with the FDA for each product, product style, container size and type and processing method.A low-acid canned food (LACF) is any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85.Our firm assists with filing scheduled processes with the FDA.
Cosmetics

A cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

  1. Labeling – The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing cosmetic products under FDA’s jurisdiction. All cosmetics marketed in the United States must comply with the labeling requirements.Our firm can prepare and/or review your cosmetic labels in order to comply with FDA regulations.
  2. Cosmetic and a Drug – Certain products meet the definitions of both a cosmetic and drugs. In these situations, the products must comply with both FDA cosmetic regulations and FDA drug regulations.Our firm assists with meeting both categorical FDA regulations.
Dietary Supplements

FDA regulates both finished dietary supplement products and dietary ingredients.A dietary supplement is a product intended for ingestion that contains a “dietary ingredient” intended to add further nutritional value to (supplement) the diet. A “dietary ingredient” may be one, or any combination, of the following substances:

  • a vitamin
  • a mineral
  • an herb or other botanical
  • an amino acid
  • a dietary substance for use by people to supplement the diet by increasing the total dietary intake
  • a concentrate, metabolite, constituent, or extract

See http://www.fda.gov/AboutFDA/Transparency/Basics/ucm195635.htm.

  1. Labeling – The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Dietary Supplement Health and Education Act of 1994 (the DSHEA) are the Federal laws governing dietary supplements under FDA’s jurisdiction. All dietary supplements marketed in the United States must comply with the labeling requirements.Our firm can prepare and/or review your dietary supplement labels in order to comply with FDA regulations.
  2. New Dietary Ingredient – The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements containing “new dietary ingredients” notify the Food and Drug Administration about these ingredients. A “new dietary ingredient” is a dietary ingredient that was not in the United States food supply in a chemically unaltered form before October 15, 1994. Generally, the notification must include information indicating that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.Our firm assists in determining whether the new dietary ingredient notification requirements apply to your dietary supplements and if so, submit a new dietary notification with FDA.
Medical Devices

FDA regulates all medical devices. A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • 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
  • 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 of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
  1. Labeling Labeling regulations with respect to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations. Labeling of a medical device is dependent upon the type of medical device it is. Further, labeling includes all printed matter accompanying the article, thus advertising is included within the definition of printed matter.Our firm reviews your medical device and its applicable labeling requirements to be in compliance with the FDA.
  2. Registration and Listing Owners or operators of establishments or facilities that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration. A foreign establishment must identify a United States Agent.Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.Our firm assists with the registration, acting as a United States Agent, and listing process for your medical device.
  3. Device Classification FDA classifies medical devices based on the health risks associated with the use of device. Devices are classified under Class I, Class II, or Class III.
    • Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls.
    • Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness.
    • Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed.

    Our firm reviews your medical device and offers advice on the FDA classification process.

  4. 510(k) Clearances Section 510(k) of the Food, Drug and Cosmetic Act (the FD&C Act) requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least ninety (90) days in advance (known as Premarket Notification – also called PMN or 510(k)).This notification allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories or it is a “new” medical device (not in commercial distribution prior to May 28, 1976) and requires a classification determination.Our firm assists medical device manufacturers in the premarket notification process.
Color Additives

Under theFederal Food, Drug, and Cosmetic Act (the FD&C Act), generally color additives are subject to FDA approval/certification before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time.

Our firm reviews your color additives, confirms certification, and or exemption for FDA compliance.

Enforcement

Notice of FDA Action

Regulated products must comply with the FDA’s Food, Drug and Cosmetic Act. Any products entering the United States that are found to be or are suspected of being non-compliant are detained for further physical examination. The FDA district office issues a “Notice of FDA Action.” This notice specifies the nature of the violation (e.g. Misbranding or Adulteration) and gives the consignee or owner of the product an opportunity to respond and provide evidence as to the admissibility of the product or to request recondition (FDA Form 766).

In the notice there typically is a “Response By” date by which you must submit your response. If you do not respond by the specified date, the FDA will issue another Notice of FDA Action that will refuse admission of the product. You will be ordered to export the product elsewhere or destroy the product within (ninety) 90 days (See Notice to Mark and/or Notice to Redeliver). Further, it is highly difficult to have the FDA rescind a refusal once one has been issued.

Our firm handles FDA detentions, refusals, and reconditioning requests, to help your FDA regulated goods get released.

Import Alert Removal

An FDA Import Alert is a list of firms and their products and that appear to be in violation of the Food Drug and Cosmetic Act (the FD&C Act). The FDA is providing a warning to importers around the world that the company’s products present safety concerns.

The FDA is able to automatically detain said products at the border, also known as Detention Without Physical Examination (“DWPE”). Although many products flagged with an Import Alert can still be imported into the U.S., it becomes a delayed process for importers.

If the FDA opts to refuse a shipment as a result of the importer doing nothing about an automatic detention, the shipment is either exported or destroyed. It is also possible for the FDA to request United States Customs and Border Protection to seize the detained products.

The FDA has set-up a comprehensive Import Alert page allowing users to search by company name, country and other criteria.

If a company is placed on the FDA’s Import Alert (a.k.a. Red List), it cannot be removed until sufficient evidence is produced, showing the merchandise meets FDA compliance requirements.

The exact methods used for removal may be listed in the Import Alert. Generally, FDA requires that at least five consecutive shipments enter the U.S., with at least one of those being audited for compliance by the FDA.

In addition to the auditing process, a Petition is to be filed directly with the FDA, requesting removal from the list. Important information included in a Petition includes the specifics of the products in question, their entry numbers, remedial measures taken to resolve the import alert issues, and a variety of other relevant documentation.

Our firm frequently prepares and files petition for removal from the FDA Import Alert list.

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