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    • 5th Ed. Vol. 1 Chpt. 1
    • 5th Ed. Vol. 1 Chpt. 2
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    • 5th Ed. Vol. 1 Chpt. 30
    • 5th Ed. Vol. 1 Chpt. 31
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    • 5th Ed. Vol. 1 Chpt. 37
    • 5th Ed. Vol. 1 Chpt. 38
    • 5th Ed. Vol. 1 Chpt. 39
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    • 5th Ed. Vol. 1 Chpt. 42
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    • 5th Ed. Vol. 1 Chpt. 44
    • 5th Ed. Vol. 1 Chpt. 45
    • 5th Ed. Vol. 1 Chpt. 46
    • 5th Ed. Vol. 1 Chpt. 47
    • 5th Ed. Vol. 1 Chpt. 48
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    • 5th Ed. Vol. 1 Chpt. 50
    • 5th Ed. Vol. 1 Chpt. 51
    • 5th Ed. Vol. 1 Chpt. 52
    • 5th Ed. Vol. 2 Chpt. 1
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    • 5th Ed. Vol. 2 Chpt. 28
    • 5th Ed. Vol. 2 Chpt. 29
    • 5th Ed. Vol. 2 Chpt. 29-2
    • 5th Ed. Vol. 2 Chpt. 30
    • 5th Ed. Vol. 2 Chpt. 31
    • 5th Ed. Vol. 2 Chpt. 32
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      • 5th Ed. Q.’s 1-299
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        • 5th Ed. Q. 400
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      • 5th Ed. Q.’s 450-499
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      • 5th Ed. Q.’s 500-549
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Home > Product Regulation
IEEPA’s Extraterritorial Reach (LawCustoms Stream Excerpt)
Published December 14, 2020 by Yuri Starikov

IEEPA’s Extraterritorial Reach (LawCustoms Stream Excerpt)

Video segment from November 24, 2020 LawCustoms Stream discussing “long-arm” or extraterritoriality reach of International Emergency Economic Powers Act (“IEEPA”). Full version of the stream is available here. Links used during this segment: United States v. Sihai Cheng, 392 F. Supp. 3d 141, 152 (D. Mass. 2019) http://justice.gov/usao-ma/pr/extradited-chinese-national-sentenced-nine-years-providing-us-goods-iran-support-its wcvb.com/article/chinese-man-accused-of-illegal-exports-to-iran-appears-in-court/8213213# scholar.google.com/scholar_case?case=9548260546660076953&q=392+F.+Supp.+3d+141&hl=en&as_sdt=6,33 Pressure transducers manufactured by MKS Instruments, Inc. Pressure transducers can be used in gas centrifuges to enrich uranium and produce weapons-grade uranium and are therefore subject to strict export controls. mksinst.com/g/productsnewbostonpost.com/2016/01/27/chinese-man-sentenced-in-boston-for-role-in-iran-nuke-plot-iranian-co-organizer-goes-free/ Extradition Seminar Extradition Statute 18 USC 3181 Please remember to join our weekly stream. Stream is held on Tuesdays at 5:30 p.m. EST (New York Time). Link and details are available at lawcustoms.com/

Read More IEEPA’s Extraterritorial Reach (LawCustoms Stream Excerpt)

Product Regulation Training & Development

IEEPA

Ignorance of the Law IS a Defense under IEEPA (LawCustoms Stream Excerpt)
Published December 7, 2020 by Yuri Starikov

Ignorance of the Law IS a Defense under IEEPA (LawCustoms Stream Excerpt)

Video segment from November 24, 2020 LawCustoms Stream discussing implications of the culpable mental state under criminal portion of the International Emergency Economic Powers Act (“IEEPA”). Full version of the stream is available here. Links used during this segment: Sec. 1705: Penalties United States v. Zhi Yong Guo, 634 F.3d 1119, 1123 (9th Cir. 2011) US Attn. Office Press Release Sentence of 5 years in federal prison Manufacturer United States v. Quinn, 401 F. Supp. 2d 80, 101 (D.D.C. 2005) Please remember to join our weekly stream. Stream is held on Tuesdays at 5:30 p.m. EST (New York Time). Link and details are available at www.LawCustoms.com

Read More Ignorance of the Law IS a Defense under IEEPA (LawCustoms Stream Excerpt)

Product Regulation Training & Development U.S. Federal Agencies Uncategorized

IEEPA

Published August 18, 2017 by Yuri Starikov

CBP Update on “Reasonable Suspicion” under Enforce and Protect Act of 2015

CBP announced various findings with respect to suspected antidumping duty evasion under Enforce and Protect Act of 2015 (“EAPA”), a law which offers parties (allegedly) injured by imports of merchandise subject to antidumping/countervailing (ADD/CVD) duty evasion to ask CBP for a help.  Pursuant to EAPA, which is part of Trade Facilitation and Trade Enforcement Act of 2015, CBP promulgated a new part under Title 19: Part 165 – Investigation of Claims of Evasion of Antidumping and Countervailing Duties.  These findings are under case numbers 7191, 15135/7175, 7184, 7189. Findings dealt with investigations of alleged evasions of wire garment hangers and diamond saw blades and should be a must read literature for importers dealing with antidumping/countervailing duties because importers that deal high risk ADD/CVD merchandise are introduced into investigation process by CBP.  In turn, knowledge of process, can help importers to mitigate possibility of “fire and fury” under EAPA. One of the things that CBP will look for is a sign of transhipment of ADD/CVD merchandise through non-ADD/CVD territory.  As a part of investigation, CBP will focus on Shipper/Manufacturer.   CBP will review individuals who have a stake in ownership of the legal entity or entities, and whether any of these…

Read More CBP Update on “Reasonable Suspicion” under Enforce and Protect Act of 2015

Product Regulation U.S. Federal Agencies

Antidumping Customs and Border Protection Inspection

Published July 16, 2017 by Yuri Starikov

Update on FDA Reporting for Low Value Products

News for low value ($800 or less) importers of: Cosmetics; Dinnerware (including eating and/or cooking utensils); Radiation emitting, non-medical devices (e.g. microwaves, televisions, CD players, etc.); Biological samples for laboratory testing; Food, excluding ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in air tight containers intended to be stored at room temperature. Pursuant to CSMS #17-000388, “a release may be issued without notification to FDA for the purposes of determining entry admissibility under section 801(a) of the Federal Food, Drug & Cosmetic Act (the Act), if the shipment is valued at or below the current de minimis level (currently $800).”  Sec. 801(a) submission (21 U.S.C. § 381(a)), previously made via FDA Form 701 (CSMS #94-001260), and currently made via CBP Forms 3461/3461ALT/7501 where information is forwarded to FDA through CBP’s Automated Commercial Environment (ACE), provides for examination or sampling of an article offered for import. This does not mean, however, that $800 or less food shipments are exempt from prior notice (21 U.S.C. § 381(m)) requirements by virtue of its low value.  Low value is not a factor.  But! Prior notice exemption factors – 21 C.F.R. § 1.277 – are: Food for an individual’s personal use…

Read More Update on FDA Reporting for Low Value Products

Product Regulation U.S. Federal Agencies

Customs and Border Protection Food and Drug Administration Food Drug and Cosmetic Act Food Products

Published December 7, 2016 by Yuri Starikov

FDA’s Adverse Event Reporting System

Keeping with spirit of open government and that people deserve to know, Food and Drug Administration took an additional measure to spread knowledge through Adverse Event Report Data.  According to FDA’s press release, “[t]his is information that was once only available through Freedom of Information Act (FOIA) requests, but will now be easily available to researchers, consumers, and health professionals.”  The data comes in the form of .csv file.  From producer’s / distributor’s stand point, the most harmful piece of information comes in the column marked as “PRI_Reported Brand/Product Name.”  While at times overly broad, some line items list in sufficient details the product name and brand.  For example, “POLAND SPRINGS SPRING WATER” is on the list to have allegedly caused “DIARRHOEA, ABDOMINAL PAIN, RIGORS, NAUSEA” to a 29 year old male on December 2, 2003.”  Good question is how it will affect imports or prospective food imports?  FDA’s press release potentially provides answer as follows: The goal of CAERS is to provide indications, or “signals” of potential hazards. FDA uses these adverse event reports to monitor the safety of foods, including conventional foods and dietary supplements, and cosmetics. This information can, and has, led to investigations of specific products,…

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Product Regulation U.S. Federal Agencies

Food and Drug Administration Food Products

Published October 14, 2016 by Yuri Starikov

DOJ’s Voluntary Self-Disclosure Guidance for Export Control & Sanctions

Department of Justice (DOJ) October 2, 2016 guidance reaffirms its position to treat U.S. export controls and sanctions violations as an attack on the U.S. national security and DOJ’s Yates Memo guiding prosecutors to “promote greater accountability for individual corporate defendants” such as directors and employees of the company.  Guidance also places jurisdictional chart for actors involved in voluntary self-disclosure (VSD). Ordinarily, when an organization voluntarily self-discloses violations of U.S. export controls and sanctions, it presents its VSD to the appropriate regulatory agency under the procedures set forth in the agency’s regulations. * * *  Business entities should continue to submit VSDs to the Department of State, Directorate of Defense Trade Controls (DDTC) for violations of the International Traffic in Arms Regulations (ITAR); to the Department of Commerce, Bureau of Industry Security (BIS) for violations of the Export Administration Regulations (EAR); and to the Department of the Treasury, Office of Foreign Assets Control (OFAC), for violations of U.S. sanctions regulations. But, submission to the particular agency may not be enough!  If violation is “done with knowledge that it is illegal,” then VSD should also be submitted to Counterintelligence and Export Control Section of the DOJ’s National Security Division.  Guidance goes…

Read More DOJ’s Voluntary Self-Disclosure Guidance for Export Control & Sanctions

Product Regulation U.S. Federal Agencies

Department of Commerce Department of Justice Directorate of Defense Trade Controls Office of Foreign Assets Control

Published October 2, 2016 by Yuri Starikov

HTSUS 4202 Interpretative Methodology under Otter Products

On August 24, 2016, in Otter Products v. US,  Court of Appeals for the Federal Circuit (CAFC) agreed with the Court of International Trade (CIT) decision that protective cases for smartphones that are specifically designed to fit these smartphones are not classifiable under HTSUS heading 4202.  For Otter Products, LLC this decision lowered duty from 20% to 5.3%, allowing them to use HTSUS 3926.90.99 (other articles of plastic provision).  Perhaps more interesting, if not important, outcome of the opinion is the analysis and well-reasoned attack on the part of both plaintiff and defendant. HTSUS 4202 heading provides for: Trunks, suitcases, vanity cases, attache cases, briefcases, school satchels, spectacle cases, binocular cases, camera cases, musical instrument cases, gun cases, holsters and similar containers; traveling bags, insulated food or beverage bags, toiletry bags, knapsacks and backpacks, handbags, shopping bags, wallets, purses, map cases, cigarette cases, tobacco pouches, tool bags, sports bags, bottle cases, jewelry boxes, powder cases, cutlery cases and similar containers, of leather or of composition leather, of sheeting of plastics, of textile materials, of vulcanized fiber or of paperboard, or wholly or mainly covered with such materials or with paper: Since smartphone cases are not specifically provided under heading notes,…

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Court of Appeals for the Federal Circuit Court of International Trade Customs and Border Protection Harmonized Tariff Schedule Classification HTS Heading 4202

Published September 27, 2016 by Yuri Starikov

When you see “healthy” on food package, what does it mean?

Food and Drug Administration (FDA) continues to brainstorm the regulatory framework surrounding the word “healthy” on food products.  September 2016 guidance advises that the “healthy” nutrient content claim can be used if the food: Meets specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, sodium, as well as requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber; The criteria are linked to elements in the Nutrition Facts label and serving size regulations; When used with an explicit or implicit claim or statement about a nutrient (e.g. “healthy, contains 3 grams of fat”), suggests that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations. As FDA continues to develop “healthy” definition ingredients, it seeks comments from the public. Federal Register Notice for the Guidance for Industry  Federal Register Notice for the Request for Information Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages “Healthy” on Food Labeling 

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Published September 20, 2016 by Yuri Starikov

FDA Posts 2016 FSMA Renewal Announcement

Food and Drug Administration posted Biennial Registration Renewal.  All food facilities must renew their registration with FDA from October 1, 2016 through December 31, 2016.  FDA renewal post is available at http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm324780.htm. Registration requirement applies to domestic (U.S.) and foreign (non-U.S.) food facilities. Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.  

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Food and Drug Administration Food Drug and Cosmetic Act Food Products

Published April 12, 2016 by Yuri Starikov

19 C.F.R. 12.42 Hammer: Battle of Ideas, Exploitation, Elimination of Competition

Last week entities associated with “Cotton Campaign” filed a petition alleging that entities such as Ikea sell products from Turkmenistan that are made through use of forced labor. The complaint is based on CBP regulation under 19 C.F.R. § 12.42, stating in relevant part: (b) Any person outside the Customs Service who has reason to believe that merchandise produced * * * is likely to be, imported into the United States and, if the production is with the use of forced labor * * * that merchandise of the same class is being produced in the United States in such quantities as to meet the consumptive demands of the United States may communicate his belief to any port director or the Commissioner of Customs. Every such communication shall contain, or be accompanied by, (1) a full statement of the reasons for the belief, (2) a detailed description or sample of the merchandise, and (3) all pertinent facts obtainable as to the production of the merchandise abroad. If the foreign merchandise is believed to be mined, produced, or manufactured with the use of forced labor or indentured labor under penal sanctions, such communication shall also contain (4) detailed information as to the…

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