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08

CBP Officers in San Juan Seize 10,000 Counterfeit Toys
U.S. Customs & Border Protection

SAN JUAN, Puerto Rico U.S. Customs and Border Protection (CBP) field operations officers completed the seizure of 10,000 counterfeit toy dolls arriving in a shipment from China.  The estimated domestic value of the shipment is $41,250.

CBP’s highly trained officers inspected a container whose contents appeared to be non-compliant U.S. Consumer Product Safety Commission (CPSC) requirements.   CBP import specialists examined samples of the items that were determined to be counterfeit.

“This high value seizure is one of many successes marking CBP’s longstanding commitment to combating importation of illicit merchandise bearing counterfeit trademarks in San Juan,” said Edward Ryan, Assistant Director of Field Operations for Trade in Puerto Rico and the US Virgin Islands. “Our CBP officers and import specialists are committed to preventing counterfeit goods from entering the commerce of the United States.”

In fiscal year 2015, the San Juan Field Office seized 287 shipments for violations of Intellectual Property Rights (IPR), with a combined domestic value of $747,416.

Trade in these illegitimate goods is associated with smuggling and other criminal activities, and often funds criminal enterprises. CBP protects businesses and consumers every day through an aggressive IPR enforcement program

CBP targets and seizes imports of counterfeit and pirated goods, and enforces exclusion orders on patent-infringing and other IPR violative goods.

The flow of counterfeit and pirated goods is a global problem that requires vigorous collaboration between customs agencies and rights owners to ensure effective intellectual property enforcement at the border.  Working with CBP provides many benefits for rights owners of patents, copyrights, and trademarks to ensure maximum intellectual property rights protection.


When Component Part Testing Can Be Used and Which Textile Products Have Been Determined Not to Exceed the Allowable Lead Content Limits: Amendment; Delay of Effective Date; and Reopening of Comment Period
Consumer Product Safety Commission

Action: Direct final rule; delay of effective date and reopening of comment period.

Summary: The Consumer Product Safety Commission (“Commission” or “CPSC”) published a direct final rule (“DFR”) and notice of proposed rulemaking (“NPR”) in the same issue of the Federal Register on October 14, 2015, clarifying when component part testing can be used and clarifying which textile products have been determined not to exceed the allowable lead content limits. Because the comment period deadline for the DFR was stated incorrectly on regulations.gov, the Commission is reopening the comment period to accept comments submitted by January 13, 2016, and is delaying the effective date of the DFR to February 12, 2016.

Dates:  The effective date of the direct final rule published on October 14, 2015, at 80 FR 61729, which was delayed from December 14, 2015, until January 13, 2016 by a document published on November 19, 2015 at 80 FR 72342, November 19, 2015, is further delayed from January 13, 2016, until February 12, 2016. The rule will be effective unless we receive a significant adverse comment. If we receive a significant adverse comment, we will publish notification in the Federal Register withdrawing this direct final rule before its effective date. The comment date is extended to January 13, 2016.

Addresses: You may submit comments, identified by Docket No. CPSC-2011-0081, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through: http://www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

Supplementary Information

On October 14, 2015, the Commission published a DFR and an NPR in the Federal Register, clarifying when component part testing can be used and clarifying which textile products have been determined not to exceed the allowable lead content limits. (DFR, 80 FR 61729 and NPR, 80 FR 61773). In response to a request for additional time to comment, the Commission published a document extending the comment period until December 14, 2015, and providing that unless the Commission receives a significant adverse comment by December 14, 2015, the rule would become effective on January 13, 2016. 80 FR 72342. The comment period for the DFR was stated incorrectly on regulations.gov as January 13, 2016. Therefore, the Commission is publishing this document to reopen the comment period to allow for submission of comments until January 13, 2016, and delaying the effective date, accordingly, to February 12, 2016.


USITC: News Releases and Documents
United States International Trade Commission

The Federal Trade Commission has issued its biennial report to Congress on the use of the Do Not Call Registry by both consumers and businesses over the past two years.

As of September 30, 2015, the National Do Not Call Registry had more than 222 million active registrations, an increase of more than 4.9 million registrations from the previous fiscal year. In FY 2015, 2,504 businesses and other entities paid Registry access fees totaling more than $13.3 million. Another 20,596 entities accessed the Registry without paying a fee because they access five or fewer area codes or are a charity. Similar numbers of entities utilized the Registry in FY 2014 and paid access fees of more than $13.5 million.

This year’s report addresses: 1) the impact of the five-year re-registration requirement which was eliminated in 2007; 2) how the FTC is responding to new technologies that have increased the number of illegal telemarketing calls made to numbers on the Registry; 3) issues regarding number portability and abandoned telephone numbers; and 4) the impact of the established business relationship exception on consumers and businesses.

The report notes that the DNC Registry exists to provide consumers with a choice regarding whether or not to receive telemarketing calls. Accordingly, the FTC works to keep it accessible and effective for both consumers and telemarketers.

The Commission vote authorizing the report to Congress was 4-0.


Lumosity to Pay $2 Million to Settle FTC Deceptive Advertising Charges for Its “Brain Training” Program
Federal Trade Commission


Company Claimed Program Would Sharpen Performance in Everyday Life and Protect Against Cognitive Decline

The creators and marketers of the Lumosity “brain training” program have agreed to settle Federal Trade Commission charges alleging that they deceived consumers with unfounded claims that Lumosity games can help users perform better at work and in school, and reduce or delay cognitive impairment associated with age and other serious health conditions.

As part of the settlement, Lumos Labs, the company behind Lumosity, will pay $2 million in redress and will notify subscribers of the FTC action and provide them with an easy way to cancel their auto-renewal to avoid future billing.

“Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “But Lumosity simply did not have the science to back up its ads.”

According to the FTC’s complaint, the Lumosity program consists of 40 games purportedly designed to target and train specific areas of the brain. The company advertised that training on these games for 10 to 15 minutes three or four times a week could help users achieve their “full potential in every aspect of life.” The company sold both online and mobile app subscriptions, with options ranging from monthly ($14.95) to lifetime ($299.95) memberships.

Lumosity has been widely promoted though TV and radio advertisements on networks including CNN, Fox News, the History Channel, National Public Radio, Pandora, Sirius XM, and Spotify. The defendants also marketed through emails, blog posts, social media, and on their website, Lumosity.com, and used Google AdWords to drive traffic to their website, purchasing hundreds of keywords related to memory, cognition, dementia, and Alzheimer’s disease, according to the complaint.

The FTC alleges that the defendants claimed training with Lumosity would 1) improve performance on everyday tasks, in school, at work, and in athletics; 2) delay age-related cognitive decline and protect against mild cognitive impairment, dementia, and Alzheimer’s disease; and 3) reduce cognitive impairment associated with health conditions, including stroke, traumatic brain injury, PTSD, ADHD, the side effects of chemotherapy, and Turner syndrome, and that scientific studies proved these benefits.

The complaint also charges the defendants with failing to disclose that some consumer testimonials featured on the website had been solicited through contests that promised significant prizes, including a free iPad, a lifetime Lumosity subscription, and a round-trip to San Francisco.

The proposed stipulated federal court order requires the company and the individual defendants, co-founder and former CEO Kunal Sarkar and co-founder and former Chief Scientific Officer Michael Scanlon, to have competent and reliable scientific evidence before making future claims about any benefits for real-world performance, age-related decline, or other health conditions.

The order also imposes a $50 million judgment against Lumos Labs, which will be suspended due to its financial condition after the company pays $2 million to the Commission. The order requires the company to notify subscribers who signed up for an auto-renewal plan between January 1, 2009 and December 31, 2014 about the FTC action and to provide a means to cancel their subscription.

The Commission vote authorizing the filing of the complaint and proposed stipulated order was 4-0, with Commissioner Julie Brill issuing a separate concurring statement. The FTC filed the complaint and proposed order in the U.S. District Court for the Northern District of California, San Francisco Division.

The FTC is a member of the National Prevention Council, which provides coordination and leadership at the federal level regarding prevention, wellness, and health promotion practices. This case advances the National Prevention Council’s goal of increasing the number of Americans who are healthy at every stage of life. This case is part of the FTC’s ongoing efforts to protect consumers from misleading health advertising.

NOTE: The Commission authorizes the filing of a complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. A stipulated order has the force of law when signed by the district court judge.


US Marshals Seize Dietary Supplements Containing Kratom
U.S. Food & Drug Administration

The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.

“We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will continue to exercise our full authority under law to take action on these new dietary ingredients, especially if they ignore the notification requirements, as part of our commitment to protecting the health of the American people.”

Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.

In February 2014, the FDA issued an import alert  that allows U.S. officials to detain imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.

In January 2016, the FDA administratively detained RelaKzpro under the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Food Safety Modernization Act (FSMA). Under its administrative detention authority, the FDA can detain a food or dietary supplement product if the agency has reason to believe the product is adulterated or misbranded. The agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.  

The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Illinois alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.

The FDA is warning consumers not to use any products labeled as containing kratom. Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA’s MedWatch program by:

  • completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
  • downloading the form, completing it and then faxing it to 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Port Authority Announces Funding Commitment to Replace Oldest Trucks Calling on Port of NY/NJ
Port of New York/New Jersey

The Port Authority announced today that it will commit $1.2 million to supplement the $9 million the agency expects to receive in federal grant funding to assist truckers operating the oldest trucks serving the Port of New York and New Jersey to buy newer, more environmentally friendly vehicles.

The emissions benefits to be realized from the newer trucks will build on a 33 percent reduction in port emissions pollutants already realized since 2006. As a result of its seaport environmental initiatives, the Port Authority received the EPA sponsored Northeast Diesel Collaborative’s Breathe Easy Leadership Award in 2012.

The $10.2 million in funds for the agency's Truck Replacement Program will provide grants for a portion of the replacement truck cost with the goal of replacing approximately 400 trucks with model year 1994 and 1995 engines that now call on the port. New trucks registered to operate in the port will be required to meet or exceed federal Environmental Protection Agency on-road emissions standards for 2007 model year heavy-duty diesel-fueled engines. The approximately 400 newer trucks would result in emissions reductions of approximately 184 tons of fine particulate matter and 3,843 tons per year of nitrogen oxides over the remaining useful lives of the vehicles being replaced. This is the equivalent of taking more than 56,000 automobiles off the road each year, based on an Environmental Protection Agency formula.

In addition, the Port Authority has proposed a modification to the rules and regulations for operating at its marine terminals (tariff). The modifications would deny access to trucks with model year 1994 and 1995 engines effective January 1, 2018, and also to require that effective March 1, 2016, new trucks seeking to serve the port terminals must be equipped with a 2007 or newer model year engine. These proposed changes to the tariff will be posted on the Port Authority website and available for comment to the Port Authority during a 30-day period beginning in February 2016. Comments can be submitted at publiccomments@panynj.gov.

The Port Authority also has established as a goal that all trucks serving its marine terminals be equipped with 2007 or newer engines, and is working closely with financial institutions to explore whether low-interest loans can be made available to truckers for the replacement of trucks serving the port with model year 1996 to 2006 engines. The Port Authority also will continue to pursue additional grant funding in support of the Truck Replacement Program.

"Our goal is to balance the need to efficiently and effectively move goods to and from our port terminals, while continuing to be good environmental stewards to the communities that surround our port facilities," said Port Authority Port Commerce Director Molly Campbell. "We believe our plan achieves this balance and will ensure that we continue to systematically address this issue for all stakeholders.”

Since the Truck Replacement Program began in 2010, the Port Authority has facilitated the replacement of 429 trucks with newer models. The program has resulted in an estimated emission reduction of 157 tons of fine particulate matter and 4,122 tons of nitrogen oxide for the remaining useful life of the vehicles which were replaced.

In addition to the truck program, the Port Authority, through its Clean Air Strategy for the Port of New York and New Jersey, has implemented other emission reduction actions at its port facilities, including the investment of more than $600 million in environmentally friendly rail facilities at all of its port terminals – including the recently approved rail facility to serve Global Terminal in Jersey City – which are funded primarily through the agency's Cargo Facility Charge. In addition, the agency has provided incentives to modernize cargo-handling equipment and to encourage the use of low-sulfur fuel in ocean-going vessels as well as to attract the cleanest vessels to the port; and incentives to retrofit port switcher locomotives with ultra low emitting GenSet engines.
 
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