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FDA Compliance and Importation

There are several components to look out for and ensure you abide by when importing items such as food or electronics into the United States. There are different procedures and protocols to reference to, when dealing with goods that may have a higher probability of being turned away at the gates because it is non-compliant with the rules of its class. Food, medical devices, and cosmetics, are a few the categories examined here as well as the proper steps to gain approval to import legally into the United States.

A. FOOD

  1. IMPORTING FOOD INTO UNITED STATES

When importing food products into the United States, shipments must comply with the Custom of Border Protection’s (CBP) procedures of the importation process.

FDA is not authorized to approve, license, or sanction individual food imports, products, labels, or shipments. However, importers must comply with its regulations as well. The FDA may detain shipments if the shipments were found not to be in compliance with the U.S. requirement. Also, imported food products are subject to FDA inspection at U.S. ports of entry.

There are two conditions that need to be met by the importers to import foods into the United State: the facilities that produce, store, or otherwise handle the products must be registered with the FDA, and prior notice of the shipments must be provided to the FDA.

  1. FOREIGN FOOD FACILITY REGISTRATION

FDA requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to be registered with FDA. There is no fee for registration. Please note that the foreign packer or holder of the food must register if the foreign facility packs or holds food after the last foreign manufacturer/processor of the food. Even if a second foreign facility is only performing a minimal activity, such as putting on a label, both facilities must be registered. If there are multiple manufacturers, all facilities are required to be registered.

A U.S. agent, who lives in or maintains a place of business in the U.S. and is physically present in the U.S. for the registration, can be designated and authorized to register the foreign facility.

The following is the link to register with the FDA: https://www.access.fda.gov/oaa/logonFlow.html

  1. PRIOR NOTICE TO THE CBP

FDA requires a prior notice to be made before the food is imported or offered for import into the U.S. Prior notice can be provided by notifying the CBP, by filing for notice through customs broker.

  1. GENERALLY RECOGNIZED AS SAFE (GRAS)

Ingredients designated as Generally Recognized as Safe (GRAS), are safe to import to the United States. The basis of a GRAS product may be either (1) from scientific procedures or (2) in the case of a substance used in food prior to Jan 1, 1958, through experience based on common use in food. Also, GRAS requires common knowledge about the substance throughout the scientific community and must understand the safety of substances directly or indirectly added to food.

For ingredients that are not GRAS, it is recommended to get approval from the FDA. It is also recommended to get a lab report or conduct a scientific analysis on Gingko Powder to demonstrate its safeness in food products.

  1. LABELING

Food products distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. All labeling information required by law or regulations must be in English. The following information must appear on the packaging:

  • An identity An identity statement

Indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration. The statement of identity must appear on the front label, or location that is most likely to be seen by the consumer at the time of purchase. 

  • An accurate statement of the net quantity of ingredients

The label on each package of the food product shall bear a declaration of the name of each ingredient in descending order of predominance by weight. The ingredient that is most prevalent by weight is listed first, and the ingredient that is least prevalent by weight is listed last.

The declaration shall appear on packaging in letters not less than 1/16 inch in height and without obscuring design, vignettes, or crowding.

  • An accurate statement of the net quantity of nutrients

The label on each package of food products shall bear a Nutrition Facts label, which lists the name of all nutrients contained in the product. The heading “Nutrition Facts” must be the largest font size in the nutrition label.

  • Name and place of business

Including the street address, city, state, and ZIP Code. If the name and address are not those of the manufacturer, the label must say “Manufactured for…” or “Distributed by…,” or similar wording expressing the facts.

B. MEDICAL DEVICES

  1. UNIQUE DEVICE IDENTIFICATION (UDI)

Since 2013, FDA has no longer issued NDC labeler codes for medical devices and the device identification system has been replaced by the UDI system. To be issued an UDI, an FDA-accredited issuing agency should be contacted. Currently, there are only three such agencies.

In our case, the client would need to contact one of the three FDA-accredited issuing agencies to apply for an UDI.

  1. ESTABLISHMENT REGISTRATION AND LISTING

Owners or operators of places of business 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. The annual registration user fees for fiscal year 2019 was $4,884 and fiscal year 2018 was $5,236. The annual registration user fees for fiscal year 2021 is $5,546. If a device requires a premarket approval or notification before being marketed in the U.S., then the owner or operators should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE). All registration must be submitted electronically.

For domestic establishments, all contract manufacturers/packagers, contract sterilizers, any importers who further the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user must register, Re-labelers, re-manufactures, and re-processors must also register.

For foreign establishments, all contract manufacturers/packagers, contract sterilizers, foreign exporters of devices located in foreign country, specification developers, re-labelers, re-manufactuers, and re-processors must register.

  1. 510(K) CLEARANCES FOR MEDICAL DEVICE

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance. This premarket notification allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. For a 510(k) cleared submission, it is not legal to advertise it as “FDA-approved,” rather it should called a “510(k) cleared device.”

Under the FDAMA, FDA exempted all Class I devices from the requirement of premarket notification, unless the device is intended for a use that is of substantial importance in preventing impairment to human health or presents a potential unreasonable risk of illness or injury. Also, FDA has the authority to directly exempt certain Class II devices rather than first down-classifying them to Class I. Under 63 FR 3132, a listing of Class II devices has been exempted from the premarket notifying. Furthermore, pre-amendments Class III devices for which general controls or special controls are sufficient to ensure safety and effectiveness will eventually be down classified to either Class I or to Class I. However, the Class III devices, that are not appropriate for reclassification, will remain in that class and will be subject to either premarket approval (PMA) or product development protocol notification (PDP) requirements.

A 510(k) submitter should submit two copies of its 510(k) to CDRH’s or CBER’s Document Control Center (DCC). One of the two copies must be an electronic copy. When the DCC receives the submission of 510(k), a unique control number or “510(k) number” will be assigned. It is a number that starts with a letter “K” and is followed by 6 digits. Once the proper user fee has been paid and a valid eCopy has been provided, the DCC will email an acknowledgment letter to the contact person on the 510(k) submission.

The acknowledgement Letter will identify the date of the receipt and the 510(k) number assigned to the submission. However, the Acknowledgment Letter is not a marketing clearance letter.

After sending the Acknowledgement Letter, the appropriate branch of DCC will conduct the acceptance review and the substantive review. The result of the acceptance review will be received within 15 days of the submission to the appropriate branch. A substantive review is a comprehensive review of the 510(k) submission and conducted after the acceptance review. The substantive review occurs within 60 calendar days of receipt of the 510(k) submission. After the substantive review, the reviewer may choose if an interactive review is necessary. An interactive review is a review that allows the reviewer to request additional information. The decision of the 510(k) will be made in around 90 calendar days.

 In a typical 510(k) application, the following forms may be submitted:

  • Premarket Notification Class III Certification and Summary
  • Premarket Notification Truthful and Accurate Statement
  • Premarket Notification 510(k) Statement
  • Exempt Device Review Form
  • Indication of Use

            The FDA doesn’t have a statutory requirement on conducting scientific research on the product. However, it is recommended to advise the client to conduct a scientific research on the product about its ingredients and characteristic of the products in order to complete the detail descriptions of the 501(k) applications.

            The following data from the scientific research may be needed:

  • All ingredients
  • Appearance, specific gravity, pH value, and solubility
  • Packaging unit and packaging material (bottle and cap)
  • Sterility
  • Chemicals that formulated the device
  • Effects of the chemicals that formulated the device
  • The period of the shelf-life (Shelf-Life Stability Report may be needed)
  • Dosage form, dosage per use, method of use, area of use, prescription/OTC, environment of use, solvent, humectants/moisturizers, and sweeteners/humectants
  • Flavor, buffers, colorant, thickeners/binders, surfactant, and preservatives

Also, it is recommended to the client to conduct a bench test comparing the device and a predicate device.

  1. PREMARKET APPROVAL (PMA)

Unlike a 510(k) application that is needed to prove that the device is “substantially equivalent” to a predicate device, a PMA application is for a new or modified device to prove to the FDA that it is safe and effective. PMA devices can be legally advertised as “PMA-approved” or “FDA-approved.”

In an application of PMA, the standard is higher than a 510(k). In addition to laboratory studies, a human use data from a formal clinical study is required. FDA usually makes its decision on the application within 180 days.

  1. IMPORT PROCESS FOR ALL MEDICAL DEVICES

All medical devices that are imported into the U.S. must meet CBP requirements in addition to FDA. Any products that do not meet FDA regulatory requirement may be detained. A custom broker should be contacted to prepare the necessary documents to import all medical devices.

If a product appears to be non-compliant, the FDA district office will issue a “Notice of FDA Action.” The owner or consignee is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. If the owner fails to submit evidence that the product is in compliance or fail to submit a plan to bring the product into compliance, FDA will issue another “Notice of FDA Action” to reject the admission of the products. Within 90 days, the products must be exported or destroyed.

 FDA may examine certain devices to assure their safety and effectiveness. A “Notice of FDA Action” will be issued to notify the importer. An FDA laboratory will examine the product to check if the product is in compliance.

  1. HUMANITARIAN DEVICE (HDE) APPROVAL

A HDE application is similar in both form and content to a premarket approval (PMA) application but is exempt from the effectiveness requirements of a PMA. However, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The HDE application must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

Once HDE application is approved, the marketing of the humanitarian use device (HUDs) is approved. A HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States each year. On the labeling for a HUD, it must state that the device is a humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.

C. COMESTICS

  1. FACILITY REGISTRATION

Currently, there is no mandatory requirement in registering the facility that manufactures, packs, or distributes the cosmetic products. If a company would like to register on a voluntary basis, it can participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP).

  1. IMPORTING

Cosmetic products and ingredients, other than color additives, do not need FDA approval before they enter the U.S. However, they must not be adulterated or misbranded. They must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled.

It should be aware that some personal care products meet the definition of drugs or the definition of both cosmetic and drugs. Under the U.S. law, a drug product is subject to requirements such as premarket approval.

A cosmetic product may be refused entry into the United States if it appears not to comply with applicable U.S. laws and regulations in any way. The following are the common reasons for refusal:

  • Ingredients or contaminants that cause the product to be unsafe
  • Color additive violations: All color additives must be approved by FDA for the intended use; some must not be used unless they are batch-certified in FDA’s laboratories. Misuse of color additives makes a product adulterated.
  • Prohibited and restricted ingredients: Violating the restrictions on the use of these substances makes a cosmetic adulterated
  • Microbial contamination: Sterility is not required for cosmetic products, but microbial contamination can pose a health hazard and therefore make a product adulterated
  • Labeling violations, such as deficiencies in the ingredient declaration, or failure to include all required labeling information in English
  • Claims that cause a product marketed as a cosmetic to be subjected to regulation as a drug under U.S. law
  1. PROHIBITED INGREDIENTS

It is against the law to use any ingredient that makes a cosmetic harmful when used as intended. The following lists are the ingredients that are specifically prohibited or restricted by the FDA:

  • Bithionol
  • Chlorofluorocarbon propellants
  • Chloroform
  • Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide)
  • Hexachlorophene
  • Mercury compounds
  • Methylene chloride
  • Prohibited cattle materials
  • Sunscreens in cosmetics
  • Vinyl chloride
  • Ziconium-containing complexes
  1. COLOR ADDICTIVES

If the cosmetic product contains a color additive, the product must be approved and certificated by FDA. To be approved by FDA, the product must comply with a specific regulation addressing a substance’s use, specifications, and restrictions. In addition to approval, a number of color additives must be batch certified by FDA if they are marketed in the U.S. to be batch certified, it means that FDA chemists have analyzed a sample from the batch and found that it met the requirement. All the requirements to be approved and certified are stated in the Code of the Federal Regulations.

A color certification account can be opened to obtain Batch Certification. To do this, the company needs to email letter with the name of the company, all addresses of the manufacturers, businesses and warehouses, contact information for company representative who will sign request letter, and, if foreign companies contact information for the U.S. agent. The email should be sent to [email protected].

During the Batch Certification’s process, FDA will evaluate the physical appearance and chemically analyze it for purity, moisture, residual salts, unreacted intermediates, colored impurities other than the main color, any other specified impurities, and the heavy metals lead, arsenic, and mercury. When it is found that the sample meets the requirements of the regulations, the FDA issues a certification, which identifies the color additive, the batch weight, the uses for which the color additive is certified, the name and address of the owner, and other information as required. The evaluation and analyses typically take less than five business days.

To determine whether the product needs FDA Batch Certification, this link provides the details.

  1. LABELING REQUIREMENTS

No cosmetic may be labeled or advertised with statements suggesting the FDA has approved the product. Even if an establishment voluntarily registered itself through the FDA’s VCRP, it cannot label itself as “FDA approved.” All required information on the label must be in English. On the label, there should be an identity statement, which indicates the nature and use of the product. In addition to the identity statement, the label should include an accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure.

Also, the following must appear on the information panel:

  • Name and place of manufacturer’s, packer’s, distributor’s business
  • Distributor statement such as “Manufactured for…” or “Distributed by…”
  • Material facts
  • Warning and caution statements
  • Ingredients

Bulk cosmetics are permitted to import the cosmetics without labeling and must label them in the United States before marketing them if the person introducing the shipment is the operator of the establishment where the shipment is going to be repackaged and labeled.

If you believe you may be in a legal situation pertaining to intellectual property rights and require an experienced attorney specializing in this field, please contact The Wang IP Law Group, P.C. We have attorneys familiar with the intricacies of importations and FDA involvement that can ultimately allow you to legally sell and distribute your products and goods.

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Wang IP Law Group, P.C. is a Los Angeles based full service legal firm that specializes in intellectual property law (patent, trademark, copyright, and licensing agreement), business and commercial litigation, and a wide range of other legal matters including immigration, real estate, and landlord/tenant cases. Our multilingual attorneys represent clients from all over California and internationally from China, Taiwan, Hong Kong, Japan, and Israel.

If you have questions or would like a consultation in regards to the content of this publication, please contact us by calling (888) 827-8880 or email us at [email protected]. For more information about the firm and the services please visit www.TheWangIPLaw.com.

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