CSMS #42590577 - Filing Entries of Hand Sanitizers for FDA - U.S. Customs & Border Protection
The U.S. Food and Drug Administration (FDA) is providing this update to clarify expectations regarding filing entries of hand sanitizers.
FDA has recently become aware that some entries of hand sanitizers have been disclaimed to FDA, and the full message set was not filed for FDA review. Additionally, we are aware that some entries of hand sanitizers have been transmitted as cosmetics instead of drugs.
Hand sanitizers are drugs regulated by the FDA and are generally considered as over-the-counter (OTC) drug products. Hand sanitizers (and other drugs) imported into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR). As such, entries of hand sanitizers are required to be filed with the FDA upon importation with the appropriate PG Message set data for OTC drug products. Importers/entry filers should not disclaim entries of hand sanitizers.
Regarding the COVID-19 public health emergency, the FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) do not affect the requirement to file entries of hand sanitizers with the FDA, or the product specific requirements verified by FDA at the time of entry.
As described in the temporary policies, foreign manufacturers whose drugs, including over-the-counter drugs, are imported into the United States are required to register with FDA and submit a listing of drugs in commercial distribution, before the drugs are imported (as required by section 510 of the FD&C Act and 21 CFR Part 207).
For more information on the drug importation process, please see: https://www.fda.gov/industry/regulated-products/human-drugs.
Tips to Help Entry Submission:
The FDA product code is determined according to the hand sanitizer’s active ingredient. For example:
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Active Ingredient in OTC Hand Sanitizer
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FDA Product Code
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Ethyl Alcohol
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62HAL05
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Isopropyl Alcohol
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62FAL23
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Benzalkonium Chloride
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62HAL99
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ACE requirements for the electronic transmission of drug products to FDA can be found in the FDA Supplemental Guide beginning on page 79. OTC drug products are transmitted using PG-01 Government Agency Program Code “DRU” and PG-01 Government Agency Processing Code “OTC”.
FDA is issuing this message as part of its continued outreach efforts to assist the import community; please make this information available to importers of record, consignees, manufacturers, shippers and other stakeholders.
CSMS #42615473 - Information: Suspension of $1.3 Billion Worth of Goods for Trade Preference under the Generalized System Of Preferences (GSP) for Thailand as Outlined in Presidential Proclamation 9955, Dated October 25, 2019 - U.S. Customs & Border Protection
BACKGROUND
On October 25, 2019, the President issued Presidential Proclamation (PP) 9955 modifying trade benefits under the Generalized System of Preferences (GSP) for Ukraine and Thailand, designating the Republic of Mali’s country status under the African Growth Opportunity Act (AGOA), and implementing the name change of “Macedonia” to “North Macedonia.” This proclamation was published in the Federal Register on October 31, 2019 (84 FRN 58567). The specific modification for Thailand is denoted below:
- THAILAND - The duty-free treatment accorded under GSP to certain products from Thailand are withdrawn because the country is not taking steps to afford its workers internationally recognized worker rights.
INFORMATION
THAILAND
With respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern daylight time on April 25, 2020, the General Note of the Harmonized Tariff Schedule of the United States (HTS) is modified. The list of products excluded from GSP eligibility for Thailand is found in Annex 2 of PP 9955 (https://www.federalregister.gov/documents/2019/10/31/2019-24008/to-modify-duty-free-treatment-under-the-generalized-system-of-preferences-and-for-other-purposes)
For questions, contact the Trade Agreements Branch at FTA@CBP.DHS.gov.
For more information on the GSP program, visit USTR’s website at
http://ustr.gov/issue-areas/trade-development/preference-programs/generalized-system-preference-gsp
Note: The direct link to PP 9955 is available at
http://www.whitehouse.gov/presidential-actions/presidential-proclamation-modify-duty-free-treatment-generalized-system-preferences-purposes-2/.
Federal Register Notice 84 FR 58567 reflecting PP9955 was published on October 31, 2019 at
https://www.federalregister.gov/documents/2019/10/31/2019-24008/to-modify-duty-free-treatment-under-the-generalized-system-of-preferences-and-for-other-purposes.
Federal Register Notices:
USITC Releases Database of Imported Products Needed for COVID-19 Response and Related Tariff and Trade Information - U.S. International Trade Commission
The U.S. International Trade Commission (USITC) today released the results of its investigation to identify imported products related to the response to the COVID-19 pandemic and provide trade-related information for them, including their 10-digit Harmonized Tariff Schedule (HTS) numbers and the source countries and applicable rates of duty of those HTS numbers.
The investigation, COVID-19 Related Goods: U.S. Imports and Tariffs, was requested by the U.S. House of Representatives’ Committee on Ways and Means and the U.S. Senate Committee on Finance in a letter received on April 7, 2020.
In requesting the investigation, the lawmakers asked the USITC to “provide a report to the Committees and the (U.S. Trade Representative (USTR)) that identifies imported goods related to the response to COVID-19, their source countries, tariff classifications, and applicable rates of duty so as to assist the Committees and USTR in proposing or taking appropriate and responsive actions.”
In response, the USITC, an independent, nonpartisan, factfinding federal agency, produced a database that provides the following information for each product it identified:
- the 10-digit HTS number the article is imported under;
- its description;
- general duty rate;
- any special or additional rates of duty imposed on the article, and the dates on which the rates were imposed, and the authorities under which they were imposed;
- whether any such duties have been suspended and, if so, the date of suspension as well how the long suspension is scheduled to last;
- the total range of duty rates imposed on such articles, including any special or additional rate of duty; and
- the major countries of origin for each HTS number identified, and the import value of that HTS number from each country for the years 2017-2019.
As requested, the USITC’s database allows the information to be sorted by the fields listed above. It also includes a “plain English” description or examples of products that fall within the identified HTS numbers and citations to sources consulted in identifying the products.
COVID-19 Related Goods: U.S. Imports and Tariffs (Investigation No. 332-576, USITC publication 5047, April 2020) is available on the USITC's Internet site at https://www.usitc.gov/publications/332/pub5047.xlsx.
At the Committee’s request, the USITC will provide any updated data runs on its website through June 30, 2020.
Anyone interested in tracking updates to the database can sign up for automatic email notifications when changes are made through the USITC’s self-subscribe email notification system. Users can create or update an existing account and select “COVID-19 Related Goods: U.S. Imports and Tariffs Updates” to subscribe to the updates.
USITC general factfinding investigations, such as this one, cover matters related to tariffs or trade and are generally conducted at the request of the U.S. Trade Representative, the House Committee on Ways and Means, or the Senate Committee on Finance. The resulting report conveys the Commission’s objective findings and independent analyses on the subjects investigated. The Commission makes no recommendations on policy or other matters in its general factfinding reports. Upon completion of each investigation, the USITC submits its findings and analyses to the requester. General factfinding investigation reports are subsequently released to the public, unless they are classified by the requester for national security reasons.
Ceramic Tile from China Injures U.S. Industry, Says USITC - U.S. International Trade Commission
The United States International Trade Commission (USITC) today determined that a U.S. industry is materially injured by reason of imports of ceramic tile from China that the U.S. Department of Commerce (Commerce) has determined are subsidized and sold in the United States at less than fair value.
Commissioners Rhonda K. Schmidtlein, Jason E. Kearns, and Amy A. Karpel voted in the affirmative. Chairman David S. Johanson voted in the negative. Commissioner Randolph J. Stayin did not participate in these investigations.
As a result of the Commission’s affirmative determinations, Commerce will issue antidumping and countervailing duty orders on imports of this product from China.
The Commission also made a negative finding concerning critical circumstances with regard to imports of this product from China. As a result, imports of ceramic tile from China will not be subject to retroactive antidumping duties.
The Commission’s public report Ceramic Tile from China (Inv. Nos. 701-TA-621 and 731-TA-1447 (Final), USITC Publication 5053, May 2020) will contain the views of the Commission and information developed during the investigations.
The report will be available by June 2, 2020; when available, it may be accessed on the USITC website at: http://pubapps.usitc.gov/applications/publogs/qry_publication_loglist.asp.
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UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, DC 20436
FACTUAL HIGHLIGHTS
Ceramic Tile from China
Investigation Nos. 701-TA-621 and 731-TA-1447 (Final)
Product Description: Ceramic tile (e.g., flooring tile, wall tile, paving tile, hearth tile, porcelain tile, mosaic tile, flags, finishing tile, etc.) contains a mixture of clay and other minerals that is fired so that the raw materials are fused together into a finished product that is less than 3.2 cm (1.3 inches) thick. All ceramic tile is subject to the scope regardless of end use, surface area, and weight; whether glazed or unglazed; water absorption coefficient; extent of vitrification; and whether or not on a backing. Ceramic tile may also include decorative features that may in spots exceed 3.2 cm (1.3 inches) in thickness. Ceramic tile “slabs” or “panels” are larger than 1 square meter (11 square feet). Subject merchandise also includes ceramic tile that undergoes minor processing (e.g., beveling, cutting, trimming, staining, painting, polishing, finishing, additional firing, etc.) in a third country prior to importation into the United States, or undergoes minor processing after importation into the United States.
Status of Proceedings:
- Type of investigations: Final-phase countervailing duty and antidumping investigations.
- Petitioners: American Wonder Porcelain, Lebanon, TN; Crossville Inc., Crossville, TN; Dal‐Tile Corp., Dallas, TX; Del Conca USA Inc., Loudon, TN; Florida Tile Inc., Lexington, KY; Florim USA, Clarksville, TN; Landmark Ceramics, Mount Pleasant, TN; and StonePeak Ceramics, Chicago, IL.
- USITC Institution Date: Wednesday, April 10, 2019.
- USITC Hearing Date: Tuesday, March 30 – Thursday, April 10, 2020 (conducted through written statements, testimony, questions and responses, and oral closing arguments).
- USITC Vote Date: Thursday, April 30, 2020.
- USITC Notification to Commerce Date: Tuesday, May 21, 2020.
U.S. Industry in 2018:
- Number of U.S. producers: 13.
- Location of producers’ plants: Alabama, California, Kentucky, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, and Texas.
- Production and related workers: 3,399.
- U.S. producers’ U.S. shipments: $1.3 billion.
- Apparent U.S. consumption: $3.5 billion.
- Ratio of subject imports to apparent U.S. consumption: 17.6 percent.
U.S. Imports in 2018:
- Subject imports: $624.4 million.
- Nonsubject imports: $1.7 billion.
- Leading import sources: Brazil, China, Italy, Mexico, and Spain.
CBP Rochester Seizes Counterfeit COVID-19 Test Kits - U.S. Customs & Border Protection
ROCHESTER, N.Y. – U.S. Customs and Border Protection (CBP) officers seized counterfeit COVID-19 test kits during the inspection of express-consignment shipments. This is the latest in several shipments that have contained counterfeit test kits.
CBP officers at the Rochester Airport were conducting inspections of express-consignment shipments and selected a package for further examination. The secondary inspection of the package resulted in the discovery of 25 COVID-19 test kits that have not been approved by the U.S. Food and Drug Administration (FDA). Since March, CBP officers at the Rochester Airport have discovered more than 600 COVID-19 test kits that are not approved by the FDA.
The FDA has issued Emergency Use Authorization (EUA) to about 50 companies that are allowed to develop and distribute COVID-19 test kits. The companies that created the test kits in these shipments have not been given authorization by FDA to sell them in the United States. As a result, the kits were seized for violations of the Federal Food, Drug, and Cosmetic Act.
“I’m proud of the continued efforts of our CBP officers here in Rochester,” said Rochester Port Director Ronald Menz. “They work day in and day out to protect our community and prevent illicit items, like these test kits, from entering where they could cause harm or give false results.”
CBP Agriculture Specialists Intercept Several Invasive Pests on the Northern Border - U.S. Customs & Border Protection
PEMBINA, N.D. — U.S. Customs and Border Protection Agriculture Specialists (CBPAS) issued 193 emergency action notifications during the first quarter of 2020. Emergency action notifications are issued when containers are found with prohibited pests.
CBPAS in Portal found a propagule of mission grass on wood packing material from Vietnam. This federal noxious weed is an invasive species that spreads by seed. Native to tropical Africa, mission grass has been introduced in several countries as feed for cattle only to quickly invade cultivated fields and overtake crops.
Also in Portal, CBPAS targeted a rail shipment. During the inspection, several wood boring beetle trails were carved into the wood on one of the pallets holding the cargo. Following the trails resulted in finding four live wood boring beetle larvae. The larva was identified as longhorn beetles. Longhorn beetles are some of the most destructive pests of wood, causing losses to the timber industry, wildlife habitat, as well as urban landscapes.
During an inspection of a rail container in International Falls, Minnesota, CBPAS intercepted cast exoskeletons of larval khapra beetles. Khapra beetle is one of the most destructive pests of stored seeds, grains, and grain products in the world. Larvae of khapra beetle are covered in fine hair, which contaminate and spoil the products they infest, causing skin irritation and gastrointestinal distress if consumed. This tiny beetle can live in a larval state for up to seven years with minimal food and is highly resistant to insecticides.
Because of this, phytosanitary action is required when it is intercepted alive, dead, or if the cast exoskeleton is found.
Additionally, CBPAS in Pembina encountered citizens of Ghana returning to their residence in the United States. Various food items were declared including dried fish, papaya, spices, and snacks. While inspecting their luggage, a package was identified that contained bushmeat. Bushmeat is a term given to unidentified wildlife for human consumption from Africa. The wildlife in many cases is not preserved or prepared in a way that would kill disease and can be a source of many communicable diseases including Ebola. The bushmeat was seized and destroyed.
“These agriculture seizures show the significant priority Customs and Border Protection (CBP) places on our agriculture inspection program at our ports of entry,” said Pembina Area Port Director Jason Schmelz.
“Preventing harm to domestic crops and vegetation is an important role our Agriculture Specialists provide this country.”
CBP Agriculture Sspecialists are the front line in the fight against the introduction of harmful insects and diseases into the U.S. They safeguard American agriculture by stopping plant pests and exotic foreign animal diseases that could harm vital agriculture resources at our nation’s borders.