C-AIR TIMES ISSUE #666 - Friday, January 22, 2021 08:15

U.S. and UK Conclude Arrangement to Strengthen End-to-End Supply Chain Security - U.S. Customs & Border Protection

WASHINGTON — The United States and the United Kingdom have concluded an arrangement to formally recognize one another’s authorized economic operator programs.

“This arrangement will take U.S.-UK cooperation on supply chain security to the next level,” said William A. Ferrara, Executive Assistant Commissioner of the U.S. Customs and Border Protection Office of Field Operations. “Mutual recognition of the U.S. and UK authorized economic operator programs will mitigate risks, improve information sharing, and eliminate red tape for our partners in the trade community.”

“This is a great achievement and testament to three years of hard work by U.S. Customs and Border Protection and Her Majesty’s Revenue and Customs Officials, to ensure that U.S. and UK AEO traders can continue to benefit from our trading relationship,” wrote Her Majesty’s Revenue and Customs in a statement.

Authorized economic operator programs allow low-risk members of the trade community who meet internationally-recognized supply chain security standards to enjoy trade facilitation benefits. Under this arrangement, U.S. Customs and Border Protection will accept the validation of UK Authorised Economic Operators (AEO) and grant them approval status in the Customs Trade Partnership Against Terrorism (CTPAT). Her Majesty’s Revenue and Customs will likewise accept the validation of CTPAT members and grant them approval status as AEOs.

CTPAT is a voluntary, public-private partnership through which members of the trade community cooperate with CBP to protect the supply chain, identify security gaps, and implement specific security measures and best practices. By meeting stringent supply chain security requirements, CTPAT members enjoy benefits including risk mitigation and shorter wait times at U.S. borders. Since its inception in 2001, CTPAT has grown to include more than 11,400 certified partners throughout the trade community. More information about CTPAT is available at CBP.gov.

AEO status is an internationally recognized quality mark that indicates that a business’s role in the international supply chain is secure and has customs control procedure in place that meet international standards and criteria. More information about AEO status is available at GOV.uk.

This mutual recognition arrangement builds on the Customs Mutual Assistance Agreement (CMAA) that the United States and the United Kingdom concluded in December 2020. CMAAs are bilateral agreements that provide a legal framework for the exchange of information and evidence to assist countries in the enforcement of customs laws, including duty evasion, trafficking, proliferation, money laundering and terrorism-related activities.

Federal Register Notices:

Foundational Rules Provide Additional Information on the Minimum Requirements for Premarket Tobacco Product Applications and Substantial Equivalence Reports Reviewed by the Agency

Today (1/19/21), the U.S. Food and Drug Administration finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.

“The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn, M.D.

“These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”

PMTA Final Rule

A PMTA is a type of application for any new tobacco product seeking an FDA marketing order. The FDA expects all premarket applications for electronic nicotine delivery systems (ENDS) products will be submitted through the PMTA pathway. However, the FDA has also issued authorizations for combustible cigarettes, smokeless tobacco and non-combusted cigarettes through the PMTA pathway.

Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the new tobacco product(s) would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The agency’s evaluation includes such things as reviewing a tobacco product’s components, ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled, findings from consumer perception research (if conducted), and the applicant’s description of marketing plans for the product.

The PMTA final rule helps ensure these applications contain sufficient information for the FDA’s evaluation, including details on the physical aspects of a tobacco product and information on the product’s potential public health risks. The final rule describes the information an applicant must include in a PMTA for the FDA to complete a substantive review of an application. It also formalizes both the procedures the agency will follow when reviewing PMTAs and the postmarket reporting requirements for applicants that receive marketing granted orders. The final rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.

In addition to content and format requirements, the final rule formalizes the general procedures the FDA follows when evaluating PMTAs, including application acceptance, application filing and inspections. The final rule also describes PMTA-related requirements for submitting application amendments, the time for review, withdrawal of applications, changes in ownership, post-market reporting, the maintenance of records, the FDA’s communications with an applicant and the FDA’s disclosure procedures and electronic submission requirements.

The final rule also explains how applicants may submit a supplemental PMTA or a resubmission, which would improve efficiency in certain situations by not requiring the submission of a new PMTA. For example, a supplemental PMTA could be submitted when an applicant is seeking authorization for a modified version of a tobacco product for which they have already received a PMTA marketing granted order. A resubmission can be submitted to address application deficiencies following the issuance of a marketing denial order.

The FDA has finalized this rule after receiving and reviewing comments during the public comment period for the proposed rule, issued on Sept. 20, 2019. The final rule is based on the agency’s experience reviewing several types of premarket applications, including SE Reports, requests for exemptions from demonstrating SE, modified risk tobacco product (MRTP) applications, and PMTAs. The FDA has received and reviewed thousands of premarket applications for tobacco products, that range widely in the level of detail they contain. This experience has been helpful in developing the rule, which describes the information an applicant must include in a PMTA for the FDA to complete a substantive review of an application.

The FDA will also withdraw its September 2011 draft guidance, because the topics described in the guidance are addressed in the final rule.

SE Final Rule

The FDA expects SE to continue being the most commonly utilized pathway for applications for cigarettes, smokeless tobacco, cigars, hookah tobacco and roll-your-own tobacco.

In order for a new tobacco product to be found substantially equivalent, the FDA must determine either that it has the same characteristics as a predicate tobacco product, or that it has different characteristics than the predicate tobacco product but does not raise different questions of public health.

As explained in the SE final rule, the SE Reports that the FDA has received range widely in the level of detail they include. Some of these reports include very little information on the comparison of the new tobacco product with a predicate tobacco product while other reports include much more.

The SE final rule provides additional information on the minimum requirements for the content and format of SE Reports, allowing for greater predictability and efficiency for all stakeholders. The goal is for the final rule to bring greater uniformity to the consistency and completeness of SE Reports, and make the tobacco product review process more effective and efficient, providing applicants with a better understanding of the level of detail that an SE Report must contain.

The SE final rule helps ensure SE Reports contain sufficient information for the FDA to evaluate the comparison of the new tobacco product to a predicate tobacco product. This rule will help ensure that an SE Report provides information necessary for the FDA to determine whether the new tobacco product is substantially equivalent to a tobacco product that is commercially marketed (other than for test marketing) in the U.S. as of Feb. 15, 2007, as required by law.

The final rule also addresses the FDA’s communications with the applicant, the retention of records that support the SE Report, confidentiality of an SE Report, how an applicant can amend or withdraw an SE Report, how an applicant may transfer ownership of an SE Report to a new applicant, electronic submission of the SE Report and amendments.

Additional Updates

Both of these final rules are effective 30 days after publication in the Federal Register. The finalization of these rules helps ensure that all PMTAs and SE Reports that begin scientific review contain the basic information the agency needs to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. The FDA will continue to work on a separate rule for MRTP applications. That rule, when final, will provide details for those who seek to market a tobacco product as modified or lower risk, including how to organize and submit an MRTP application. The agency also will also continue efforts to assist industry in complying with federal tobacco regulations through meetings, webinars and guidance documents.

By Sept. 9, 2020, manufacturers of deemed new tobacco products – including e-cigarette products – that were on the market as of Aug. 8, 2016 were required to submit a premarket application to the FDA. However, the agency is currently enjoined from enforcing premarket requirements for premium cigars. The agency continues to process the large number of submissions received and has already begun reviewing many applications. In the coming weeks, the FDA intends to provide a more detailed update on the agency’s progress since the Sept. 9, 2020 deadline.

40,000 Unapproved Prescription Pills Stopped by CBP Officers in Minnesota - U.S. Customs & Border Protection

MINNEAPOLIS — U.S. Customs and Border Protection (CBP) officers in Minneapolis recently seized a shipment containing more than 40,000 prescription pills worth more than $12,000.

On January 11, CBP officers inspected a shipment arriving from Laos. The parcel, manifested as Tiffy Dey, was inspected to determine if the goods were admissible in accordance with CBP regulations. CBP officers found 15,000 Amoxicillin pills, 10,000 Indomethacin tablets, 5,000 Norpramin Paracetamol and Verakhai-i Paracetamol Tablets, 4,000 Tiffy Dey Paracetamol Tablets, 1,020 Neo Codeine pills and 500 Dexamethasone Acetate pills; a total of 40,520 pills.

This shipment contained commercial quantities of over-the-counter medications with no FDA notification and one schedule II medication which had no prescription or FDA notification. The U.S. Food and Drug Administration prohibits the importation, by mail or in person, of fraudulent prescription and nonprescription drugs and medical devices. The shipment was addressed to a residence in Brooklyn Park.

Medications purchased from online sources can be improperly produced and not meet pharmacological specifications and safeguards that ensure the protection of human health. Prescription medications manufactured by non-regulated foreign companies often contain dangerous contaminants or ineffective compounds, and though their packaging and labeling can be similar to genuine products, inconsistent ingredients and sub-par quality controls can cause harm to consumers.

“Protecting and safeguarding consumers from inferior products is vital component of CBP’s border security mission,” said Augustine Moore, Area Port Director-Minneapolis. “This is a testament to the commitment made by our officers to keep dangerous goods out of the country.”

Counterfeit and/or fake medications are substandard and can cause significant harm. These products are then packaged and labeled to look like the real thing.

$8 Million in Fake Cartier Bracelets seized by CBP in Cincinnati & Louisville on the Same Day from the Same Shipper Heading to the Same Address - U.S. Customs & Border Protection

CINCINNATI — As E-Commerce is a growing segment of the U.S. economy, and consumer habits continue to change, U.S. Customs and Border Protection (CBP) officers continue to stop shipments that contain illicit goods that pose economic security risks. On January 14, in two separate locations, Cincinnati, Ohio, and Louisville, Kentucky, CBP officers halted shipments, arriving from Hong Kong, which contained more than 800 counterfeit designer bracelets.

CBP officers in Cincinnati detained two parcels heading to a residence in West Palm Beach, Florida. CBP officers inspected the parcels to determine the admissibility of its contents in accordance with CBP regulations.

Inside the first box officers found 267 Cartier bracelets, and the other box contained another 137 Cartier bracelets.

On the same night, officers in Louisville were inspecting different parcels to determine their admissibility. A shipment arriving from same location in Hong Kong and heading to the same residence in West Palm Beach, Florida as Cincinnati’s parcel, was inspected and found to contain 401 Cartier rings and bracelets.

The jewelry pieces were reviewed by an import specialist who determined the items were counterfeit. If these items were real, the total MSRP for Cincinnati’s seizure would have been over $4.17 million, while Louisville’s seizure would have been more than $4.55 million; a total of $8.72 million

“This is a significant seizure for CBP, but unfortunately, CBP officers see counterfeit shipments like this every day,” said Richard Gillespie, Port Director-Cincinnati. “I’m extremely proud of these officers determination in stopping illicit shipments, and our commitment to protecting the American economy.”

“Driven by the rise in E-commerce, the market for counterfeit goods in the United States has shifted in recent years from one in which consumers often knowingly purchased counterfeits to one in which counterfeiters try to deceive consumers into buying goods they believe are authentic,” said Thomas Mahn, Port Director-Louisville.. Consumers are unaware that they’re buying a dangerous product as the counterfeit is just that good.”

U.S. Customs and Border Protection (CBP) has the authority to detain, seize, forfeit, and ultimately destroy merchandise seeking entry into the United States if it bears an infringing trademark or copyright that has been registered with the U.S. Patent and Trademark Office (USPTO) or the U.S. Copyright Office (USCOP), and has subsequently been recorded with CBP. As an intellectual property right (IPR) owner, you can partner with CBP to receive border enforcement of your registered trademarks and copyrights through CBP’s e-Recordation Program. There are several steps an IPR owner can take to ensure their trademarks and copyrights are enforced at all U.S. Ports of Entry.

Every year, CBP seizes millions of counterfeit goods from countries around the world as part of its mission to protect U.S. businesses and consumers. These goods include fake versions of popular products, such as smartphones and related accessories, electronics, apparel, shoes, cosmetics, and high-end luxury goods, as well as goods posing significant health and safety concerns, such as counterfeit pharmaceuticals, bicycle and motorcycle helmets, medical devices, supplements and other consumables. Sold online and in stores, counterfeit goods hurt the U.S. economy, cost Americans their jobs, threaten consumer health and safety, and fund criminal activity. Visit the National IPR Coordination Center for more information about IPR including counterfeiting and piracy.

Nationwide in Fiscal Year 2020, CBP seized 26,503 shipments containing goods that violated intellectual property rights. The total estimated value of the seized goods, had they been genuine, was nearly $1.3 billion. CBP has established an educational initiative to raise consumer awareness about the consequences and dangers that are often associated with the purchase of counterfeit and pirated goods. Information about the Truth Behind Counterfeits public awareness campaign can be found at
https://www.cbp.gov/FakeGoodsRealDangers.

50,000 Unapproved Vaping Pens Seized by CBP Officers in Chicago - U.S. Customs & Border Protection

CHICAGO – U.S. Customs and Border Protections officers at Chicago O’Hare’s International Mail Branch recently seized 50,000 dragster Mountain Vape Pens. The shipment, originated from Hong Kong, and was destined for a residence in Alexandria, Kentucky.

The FDA determined the shipment violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) as misbranded consumer goods being imported by an unauthorized agent. Tobacco products imported or offered for import into the United States must comply with all applicable U.S. laws. Read more about the FDA’s regulations governing e-cigarettes and other tobacco products.

The shipment was seized on January 19, and was mis-manifested as Lithium Ion Battereies, a common practice used by smugglers. CBP believed the shipment was intentionally improperly labeled in order to avoid detection. Additionally, CBP presumes the products are being sold without authorization. CBP continues to work diligently to stop non-legitimate products from entering the U.S. The pens had an MSRP of $450,000.

“Our officers are dedicated to identifying and intercepting these types of shipments that could potentially harm our communities,” said Shane Campbell, Area Port Director-Chicago. “Customs and Border Protection’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers, and we will continue to work with our consumer safety partners to identify and seize unsafe and illicit goods.”

Last year the FDA announced an increased enforcement priority of electronic nicotine delivery systems, and issued detailed guidance to the industry of these new enforcement priorities that regulate the unauthorized importation of tobacco products.

CBP provides basic import information about admissibility requirements and the clearance process for e-commerce goods and encourages buyers to confirm that their purchases and the importation of those purchases comply with any state and federal import regulations.

CBP conducts operations at ports of entry throughout the United States, and regularly screens arriving international passengers and cargo for narcotics, weapons, and other restricted or prohibited products. CBP strives to serve as the premier law enforcement agency enhancing the Nation’s safety, security, and prosperity through collaboration, innovation, and integration.