FAQ

The FDA (Food and Drug Administration) is an agency of the United States government tasked with regulating a variety of commodities to protect the American public from harmful products. Their jurisdiction includes, but is not limited to, human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

Firms and products that are listed on an FDA Import Alert are automatically detained by FDA without the added step of FDA conducting an inspection, examination or sampling of the product. FDA automatically detains products on FDA Import Alert without physical examination (also called Detention Without Physical Examination or DWPE).

Customs brokers assist importers in “clearing” their imported goods through the border into the US. This involves preparing documents and/or electronic filings, calculating (and usually paying) duties, taxes, and fees, to Customs on behalf of the importer, and facilitating communication between the importer/exporter and governmental authorities.

FDA has the authority to inspect any establishment that manufactures, processes, packs, or holds food, drugs, devices, tobacco products, or cosmetics for interstate distribution (subject to some limitations related to pharmacies).

The United States Department of Agriculture (USDA) is a department within the federal government whose website describes its mission as “promoting agricultural production” and “to preserve our Nation’s natural resources.” The agencies under the umbrella of USDA “help keep America’s farmers and ranchers in business and ensure that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled” while also ensuring “the health and care of animals and plants and the health of the land.”

The United States Customs and Border Protection (CBP) is a federal law agency within the Department of Homeland Security. Among other responsibilities, CBP collects import duties, regulates and facilitates lawful international trade, and enforces various U.S. laws and regulations governing imported and exported goods on its own behalf as well as on the behalf of partner governmental agencies such as FDA, EPA, Fish and Wildlife, etc. In addition, CBP screens imported shipments at the borders for illegal substances, infested produce, and regulatory violations (among other things) in its efforts to combat illegal immigration, weapons and narcotics smuggling, and illegal importation.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) is a bureau of the United States Department of the Treasury whose website describes its mission as protecting “the public by enforcing the provisions of the Federal Alcohol Administration Act (FAA Act) to ensure that only qualified persons engage in the alcohol beverage industry.” TTB also regulates production, importation, and sale of alcohol. In addition, the manufacture and importation of tobacco falls under TTB as well.

Accession numbers are unique FDA identifiers for electronic product reports found in FDA’s radiation emitting electronic product database. They are assigned by the Center for Devices and Radiological Health (CDRH) and provided to electronic product manufacturers and assemblers in response to electronic product report submissions.

FDA issues Export Certificates and registers food, drug, tobacco, and medical device facilities, but FDA does not issue permits for importing food or dietary supplements. Such permits are issued by USDA/APHIS.

FDA requires that all facilities engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. provide FDA with information on the location and activities of the facility and submit to routine inspections. FDA requires companies to renew their registration every two years.

When a Food, Medical Device, Tobacco, or Drug establishment registers with FDA, the Agency issues a number that is a unique identifier for that registration. A registration number confirms that a facility is subject to FDA inspection.

“FDA registered” does not mean “FDA approved.” FDA requires all food, drug, medical device, and tobacco facilities to “register” by providing essential information about their physical location, products, and processes, and agreeing to submit to periodic FDA inspections. A registered company is not necessarily compliant with FDA regulations.

The Food Safety Modernization Act (FSMA) represents a major overhaul of the food regulations to meet the challenges of the 21st century. The Act includes the Final Rule on Accredited Third-Party Certification, Foreign Supplier Verification Programs (FSVP), the Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration, the Final Rule on Preventive Controls for Animal Food, the Final Rule for Preventive Controls for Human Food, the Final Rule on Sanitary Transportation of Human and Animal Food, and the Standards for Produce Safety Final Rule.

The Foreign Supplier Verification Program (FSVP) is part of the Food Safety Modernization Act (FSMA). It requires food importers to verify through inspections and written protocols that all links in their supply chain are observing FDA food safety practices in the preparation and transportation of food.

HARPC stands for “Hazard Analysis and Risk-Based Preventive Controls,” one of many provisions of the Food Safety Modernization Act (FSVP). This is also known as the Preventive Control Rule (PCR).

A warning letter notifies a responsible individual or firm that the FDA considers one or more products, practices, processes, or another of its activities to be in violation of the Federal Food, Drug and Cosmetic Act. According to FDA resources, this provides individuals and firms “an opportunity to take voluntary and prompt action to correct violations before FDA initiates an enforcement action.”

A “detained” shipment is a shipment that has been stopped at a port or point of entry into the U.S. while FDA or the CBP is making a determination as to whether the goods are admissible.

A “refusal” is FDA’s final decision that a detained shipment is in violation of FDA regulations. The Agency issues a Notice of FDA Action to inform the importer that their shipment must be either destroyed or exported within 90 days of the date of the Notice.

FDA’s asserts that the agency “does not approve, certify, license, or sanction individual food companies, products, or labels.”

FDA asserts that the agency “does not approve, certify, license, or sanction individual food companies, products, or labels.” FDA requires any company wishing to sell food in the U.S. to register, and through periodic inspections and postmarket enforcement action, the Agency holds the food manufacturers and importers responsible for producing food that is safe and properly labeled for public consumption.

FDA approves new drugs, biologics, food additives, color additives, and medical devices that pose a high risk of harm to the user. However, FDA does not do the testing to determine the safety and effectiveness of a product. This is the responsibility of the manufacturer. FDA experts review the results of the clinical studies and grant or deny approval based on their analysis of the data. FDA does not approve companies, food, cosmetics, or dietary supplements.

FDA does not approve cosmetics. See “What requires FDA approval?” for a more detailed explanation.

FDA defines a “medical device” as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; (2) 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; (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve 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.” 21 United States Code section 321(h).

When a medical device company registers with FDA, it must list all of the devices which it intends to introduce into the U.S. market. FDA assigns to each device a unique confidential 6-digit listing number that is preceded by the letter “D” (e.g. D287405).

Medical devices are assigned to one of three classifications depending on the level of oversight necessary to ensure the safety and effectiveness of the device. A Class 1 device (e.g. non-powered breast pumps, tongue depressors, etc.) poses little risk of harm to the user, and so they are only subject to minimal controls and most are exempt from premarket approval or notification requirements. Devices that are considered moderate risk are Class 2, and the manufacturer must demonstrate that it is “substantially equivalent” to a legally marketed device that does not require premarket approval. Class 3 devices are high-risk such as mechanical heart valves. The manufacturer must prove by way of scientific evidence, including clinical trials, that the device is safe and effective for its intended use before it can enter the market.

FDA requires the manufacturer of high risk, Class 3 devices to perform the scientific tests to verify the safety and effectiveness of the medical device the company wishes to market. FDA experts will review the data and grant or deny approval based on their analysis of evidence. See the answer to “How are medical devices classified?”

A “510(k) submission” is made to FDA by a manufacturer or distributor of a medical device that is not subject to premarket approval. The “510(k)” includes information demonstrating that the medical device to be marketed is substantially equivalent to another medical device that is currently sold legally in the U.S. Substantial equivalence means that the 510(k) sponsor must demonstrate that their device has the same intended use as the legally marketed device and has the same technological characteristics. If the technology differs, they must demonstrate that it raises no new questions of safety and effectiveness.

A 510k approval can take anywhere from 1 to 18 months. The preparation required for a 510k submission usually takes a number of months. Once FDA has received the 510k submission documents, the Agency will respond within 90 days, but this response is not necessarily an approval. Often FDA will request more information or pose questions about the submission which will “stop the clock.”

When a company registers with FDA as an Acidified Food/Low-Acid Canned Food processor, the registration requires them to outline the individual processes that are used to produce each food item. FDA assigns a number known as a “Submission Identifier” (SID) to each process.

LACF is an acronym that stands for Low-Acid Canned Food.

FDA requires all drug, medical device, tobacco, and food facilities, to register using the FDA’s Unified Registration and Listing System (FURLS). There is no fee for registering, and anyone can set up a FURLS account to submit a facility registration or you can hire a third party like FDAImports to complete the registration.

FDA has the authority to take samples of regulated products that are offered for entry into the U.S. and examine them to determine whether they meet FDA standards. FDA pays the owner for the sample. If the sample is found to be deficient in some way, FDA issues a Notice of FDA Action.

Food Facility Registration numbers are the private possession of the facility owner, and the public has no access to them. If you own a food facility and have lost the registration number, you must contact FDA FURLS help desk. Registration numbers for Medical Device Facilities are accessible through the FDA Establishment Registration and Device Listing database found here. The registration number of a Drug Establishment can be found here.

FDA does not issue food safety certificates or certificates of FDA approval. Firms that specialize in FDA compliance, like FDAImports.com LLC, often issue their own certificates verifying that a company is following procedures and producing products that meet FDA standards. These certificates can be valuable in facilitating business with suppliers or customers.

Though dietary supplements are considered “food,” FDA regulates them under a different set of regulations than those governing conventional food. FDA regulates both finished dietary supplements and dietary ingredients under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Dietary supplement manufacturers and distributors are responsible for evaluating the safety of their products and labeling them properly before they are marketed. FDA is authorized to take action against any dietary supplement on the market that is adulterated or misbranded.

The answer depends on whether Customs is making the determination as to whether a good is admissible, or whether the determination is being made by another agency. If Customs is making the determination, it has 30 days to determine whether a good is admissible or not. If it has not made the determination within the 30 days, the good is deemed to be excluded, and an importer can file a protest of that deemed exclusion. However, if the determination as to admissibility is being made by another agency (e.g. FDA), there are no time limits on Customs’ detention; rather, any time limits are determined by whatever law governs that agency’s determination. In theory, if there are no time limits that apply to that agency’s determination as to admissibility, Customs could detain the merchandise indefinitely, although there could be some due process arguments raised.

U.S. Customs and Border Protection does not require a license to import goods into the U.S. However, different government agencies require permits and licenses depending on the type of goods one is importing. FDAImports can help you determine what permits are necessary for your shipment.

GRAS is an acronym standing for Generally Recognized As Safe. FDA uses this designation to indicate that a food additive is considered safe by industry experts and is exempted from usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

“Clearance delay” or “Package available for clearance” means that Customs and Border Patrol (CBP) held the package for examination and assessment.

Conditional Release is the recognition that all goods released by CBP are released “conditionally” and may be recalled through the issuance of a Notice of Redelivery. The Conditional Release period extends for 30 days from the time of CBP release of the shipment.

The FDA has offices and employees across the United States and even in some foreign countries, but the main offices are located in Montgomery and Prince Georges Counties in Maryland. Additional buildings and employees are located around the Washington, D.C. area. The address of FDA Headquarters is:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

FDA is an arm of the executive branch of the United States federal government. As such, they are authorized to implement the laws or statutes made by Congress. In order to enact statutes such as the Food Safety Modernization Act (FSMA), FDA is empowered to create regulations that are published in the Federal Register. These regulations are intended to ensure the safety of food, drugs, cosmetics, and medical devices in the United States.

Form 483 or “Notice of Inspectional Observations” is a report issued to the management of a facility after an FDA inspection detailing those things that the inspector deems to be violations of FDA regulations.

A Class 1 device (e.g. non-powered breast pumps, tongue depressors, etc.) is a medical device that poses little risk of harm to the user and, consequently, minimal controls are sufficient to assure safety and effectiveness. Most Class 1 devices are exempt from premarket approval or notification requirements.

An Active Pharmaceutical Ingredient is the component of a pharmaceutical drug that is biologically active.

Devices that are considered moderate risk are Class 2, where minimal controls are not sufficient to assure safety and effectiveness. They are subject to “special controls.” In a premarket notification (510(k)) the manufacturer must demonstrate that it is “substantially equivalent” to a legally marketed device that does not require premarket approval.

Class 3 devices are high-risk medical devices such as mechanical heart valves. The manufacturer must prove by way of scientific evidence, including clinical trials, that the device is safe and effective for its intended use before FDA will approve it to enter the market.

The law allows a 180-day period for FDA to review a premarket approval (PMA) application. If FDA has significant questions, that time can be extended.

You contact FDA by phone, email, or in writing. The information is here.

Bioterrorism is terrorist activity involving the release of viruses, bacteria, or other toxic biological agents that can sicken or kill people and animals.

FDA has published a number of “recipes” or monographs for drugs intended to cure conditions that are common and amenable to self-diagnosis. If a drug manufacturer creates a product for external pain relief that conforms to the monograph for external pain relievers, it can be sold directly to consumers (“over-the-counter”) without a prescription. A Prescription must be purchased from a licensed pharmacist, and it must have been prescribed by a doctor or other licensed medical practitioner.

FDA has placed the burden on food manufacturers and distributors to produce food that is safe and properly labeled. Food facilities are required to register with FDA, and FDA conducts periodic inspections to verify that the facilities are operating according to current Good Manufacturing Practices (cGMP). Likewise, FDA inspects imported food at points of entry into the U.S., and utilizes recalls, corrections (e.g. relabeling), and removals to ensure that the food in the U.S. is safe and properly labeled.

A company is FDA compliant when its products and procedures are in accord with FDA standards for that industry.

FDA does not issue food safety certificates or certificates of FDA approval. Firms that specialize in FDA compliance, like FDAImports.com LLC, often issue their own certificates verifying that a company is following procedures and producing products that meet FDA standards. These certificates can be valuable in facilitating business with suppliers or customers.