Collaborating Across Borders: North American Regulators Working Together to Protect Children from Harmful Toys
U.S. Consumer Product Safety Commission
MEXICO CITY – Shoppers across North America are gearing up for the holiday toy shopping season, and federal regulators in the United States, Mexico and Canada are joining forces to help consumers shop with confidence. The U.S. Consumer Product Safety Commission (CPSC), Health Canada and Mexico’s Consumer Protection Federal Agency (PROFECO) are holding their Third North America Consumer Product Safety Summit in Mexico City this week, and protecting young children from dangerous and illegal toys is a shared goal among the safety agencies.
Collaboration among the regulators has taken place through joint industry trainings, consumer outreach and education, and three trilateral recall announcements of harmful toys and children’s products. Additional efforts have included joint oversight of product supply chains and timely responses to emerging product hazards. The vision for creating a safer marketplace for consumers across the continent includes: (1) strong safety standards that are enforced, (2) inspections at import, and (3) an emphasis on quality safety manufacturing overseas.
"As we approach the holiday season, our three jurisdictions are working as one to protect children in all three nations from harmful toys," said CPSC Chairman Elliot F. Kaye. "Despite our real advances in toy safety, we are still finding too many violative toys at our borders. All consumers, regardless of which of our three nations they come from, deserve us working together to protect them. This is why working toward seamless surveillance across North American borders is a critical part of our collaboration with Health Canada and PROFECO.”
"In today's global marketplace, close collaboration between countries is important for keeping Canadians safe,” said Dr. Jane Philpott, Minister of Health, Health Canada. “I look forward to continuing Health Canada's partnership with the CPSC and PROFECO on our shared goals for consumer product safety, including promoting toy safety this holiday season. As a mom and as Canada's new Minister of Health, I'm committed to helping keep families safe."
“Coordinated work among the consumer protection agencies in our region is the starting point to successfully face, in the near future, the challenges presented by the global economy; and, at the same time, assure every consumer that not only are their rights safeguarded, but also that the law exists to assist and protect them,” said Lorena Martínez, Mexico’s Federal Attorney for Consumer Protection (Profeco). “Only by strengthening strategic alliances and sharing efforts and experience, we will reach our mutual goals.”
In addition to working with Health Canada and Profeco, CPSC works closely with the U.S. Customs and Border Protection (CBP) to keep violative products off of store shelves and out of consumers’ homes. In the past six years, the U.S. government has stopped more than 17 million units of about 6,200 different toys that violated applicable standards from coming into the United States.
Click here to view the North American joint statement.
Here are some safety tips for all consumers to keep in mind this holiday season:
- Magnets – Children's magnetic toys are covered by a strong safety standard that aims to prevent magnets from being swallowed. High-powered magnet sets that have small magnets are dangerous and should be kept away from children. Whether marketed for children or adults, building and play sets with small magnets should also be kept away from small children.
- Balloons - Children can choke or suffocate on deflated or broken balloons. Children can also be strangled by a balloon string. Keep deflated balloons away from children younger than 8 years old. Discard torn balloons immediately.
- Small balls and other toys with small parts - For children younger than age 3, avoid toys with small parts, which can cause choking.
- Scooters and other riding toys - Riding toys, skateboards and in-line skates go fast, and falls could be deadly. Helmets and other safety gear should be worn properly at all times, and they should be sized to fit. Avoid riding scooters on streets or roadways.
Once gifts are open:
- Keep toys appropriate for older children away from younger siblings.
- Battery charging should be supervised by adults. Chargers and adapters can pose thermal burn hazards to young children. Pay attention to instructions and warnings on battery chargers. Some chargers lack any mechanism to prevent overcharging.
FDA Releases Groundbreaking Food Safety Rules to Produce Farms and Imported Foods to Modernize and Strengthen Food Safety System
U.S. Food & Drug Administration
The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules implementing the bipartisan Food Safety Modernization Act that, for the first time, establish enforceable safety standards for produce farms and make importers accountable for verifying that imported food meets U.S. safety standards. The Agency also issued a rule establishing a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities. These final rules will help produce farmers and food importers take steps to prevent problems before they occur.
An estimated 48 million people (1 in 6 Americans) get sick each year from foodborne diseases, according to recent data from the U.S. Centers for Disease Control and Prevention. Approximately 128,000 are hospitalized, and 3,000 die each year. Over the past few years, high-profile outbreaks related to various foods, from spinach to peanut products, have underscored the need to make continuous improvements in food safety.
The new rules released today – referred to as the Produce Safety rule, the Foreign Supplier Verification Programs rule, and the Accredited Third-Party Certification rule – are key elements of the comprehensive food safety overhaul envisioned in the 2011 bipartisan FDA Food Safety Modernization Act (FSMA). FSMA directs the FDA and food producers to prevent problems across the entire food system, rather than waiting to act until illness occurs. The new rules formalize industry accountability and best practices for food importers and the produce community.
“The recent multistate outbreak of Salmonella in imported cucumbers that has killed four Americans, hospitalized 157 and sickened hundreds more, is exactly the kind of outbreak these rules can help prevent,” said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine. “The FDA is working with partners across the government and industry to prevent foodborne outbreaks. The rules will help better protect consumers from foodborne illness and strengthen their confidence that modern preventive practices are in place, no matter where in the world the food is produced.”
The Produce Safety rule establishes science-based standards for growing, harvesting, packing, and holding produce that are designed to work effectively for food safety across the wide diversity of produce farms. The standards in the final rule include requirements for water quality, employee health and hygiene, wild and domesticated animals, biological soil amendments of animal origin (such as compost and manure), and equipment, tools, and buildings. When followed, the standards are designed to help minimize the risk of serious illness or death from consumption of contaminated produce. Public comments and input received during hundreds of farm visits, meetings and listening sessions have shaped the rule into one that will reduce the risk of harmful contamination while also allowing appropriate flexibility for farmers and producers.
The Foreign Supplier Verification Programs rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards and that they are achieving the same level of food safety as domestic farms and food facilities. In 2013, USDA estimated that imported food accounted for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans. The final rule ensures that importers conduct verification activities (such as audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records) based on risks linked to the imported food and the performance of the foreign supplier.
The FDA has also finalized a rule on Accredited Third-Party Certification, which is part of FSMA’s new food import safety system. This rule establishes a program for the accreditation of third-party certification bodies (auditors) to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. To prevent potentially harmful food from reaching U.S. consumers, the FDA can require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.
“The ultimate success of FSMA depends on full funding of the President’s FY 2016 budget request,” Taylor said. “This will help us train FDA and state food safety staff on the new system, fund our state partners to work with farmers on produce safety, provide technical assistance to small farms and food businesses, and successfully implement the new import system that U.S. consumers deserve and Congress envisioned.”
The FDA has finalized five of the seven major rules that implement the core of FSMA. Today’s historic rules build on the preventive controls rules the FDA finalized in September 2015, which mandate modern preventive practices in food processing and storage facilities. These rules work together to systematically strengthen the food safety system and better protect public health.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring 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.
FDA Takes Action to Protect Consumers from Potentially Dangerous Dietary Supplements
U.S. Food & Drug Administration
The U.S. Food and Drug Administration, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.
Led by the U.S. Department of Justice, the sweep included the FDA, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency.
An 11-count indictment was unsealed earlier today against USPlabs, a Dallas, Texas company that formerly manufactured highly popular workout and weight loss supplements. The indictment charges USPlabs, S.K. Laboratories Inc. and their operators with a variety of charges related to the sale of those products. The defendants were arrested/surrendered to the U.S. Marshal’s Service today. Along with the arrests, FDA and IRS special agents seized assets in dozens of investment accounts, real estate in Texas, and a number of luxury and sports cars.
The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. To the contrary, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.
The indictment also alleges that USPlabs and its principals told the FDA in October 2013 that it would stop distribution of OxyElite Pro, once the product had been implicated in an outbreak of liver injuries. The indictment alleges that, despite this promise, USPLabs engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation.
“This joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely marketed as dietary supplements,” said Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations and policy. “The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to protect Americans and bring justice.”
In November 2013, the FDA warned consumers not to use certain USPlabs products thatwere found to contain a new dietary ingredient that had not been shown to be safe for use by consumers. The ingredient, aegeline, is a synthetic version of an alkaloid (a chemical compound) that exists, in natural form, in a tree that grows in parts of Asia. In addition, the products had adverse events linked to acute liver failure or non-viral hepatitis so severe that several patients needed liver transplants, and one resulted in death.
“The Justice Department and its federal partners have joined forces to bringing to justice companies and individuals who profit from products that threaten consumer health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer. “The USPlabs case and others brought as part of this sweep illustrate alarming practices the Department found—practices that must be brought to the public’s attention so consumers know the serious health risks of untested products.”
Also as part of the sweep, the DOJ announced it filed a complaint in federal court in the District of New Jersey, on behalf of the FDA, against Bethel Nutritional Consulting Inc. of New York and New Jersey and the company’s president and vice-president. According to the complaint, Bethel and its officers distributed adulterated and misbranded dietary supplements and unapproved new drugs throughout the United States. The defendants have agreed to be bound by a consent decree of permanent injunction that orders them to cease operations until the FDA determines that they are in compliance with laws applicable to dietary supplement manufacturing, labeling, and distribution.
FDA inspections of Bethel’s operations have revealed deviations from current good manufacturing practice regulations, resulting in adulterated dietary supplements, and deviations from labeling requirements, causing the dietary supplements to be misbranded.
The FDA has also determined that Bethel distributed unapproved new drugs, because the company made medical claims that certain dietary supplement products were intended to cure, mitigate, treat, or prevent diseases, or to affect the structure or function of the body.
Additionally, certain tainted products falsely marketed as dietary supplements by Bethel contained potentially harmful active pharmaceutical ingredients, including sibutramine and lorcaserin. Sibutramine was an active pharmaceutical ingredient in Meridia, a drug approved by the FDA in 1997 for prescription treatment of obesity. Meridia was removed from the market in 2010 because of risks of serious adverse cardiovascular events, including heart attack and stroke. Lorcaserin is the active pharmaceutical ingredient in Belviq, a drug approved by the FDA in 2012 for chronic weight management in some overweight or obese adults. Lorcaserin may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Lorcaserin may also cause disturbances in attention or memory.
The FDA continues to warn consumers about the risks associated with some over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients. These products are most frequently marketed for sexual enhancement, weight loss and body building.
Within the last year, the FDA also sent warning letters to manufacturers selling dietary supplements that contain BMPEA and DMBA, two ingredients that do not meet the statutory definition of a dietary ingredient as well as to several companies selling pure powdered caffeine products that the agency determined to be dangerous and present a significant or unreasonable risk of illness or injury to consumers.
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.
Two Years in Prison for Smuggler of Cups Made from Rhino Horn
U.S. Fish & Wildlife Service
An antiques dealer has been sentenced to two years in prison for his role in a wildlife trafficking scheme in which he purchased and smuggled 16 ceremonial cups carved from rhinoceros horns and worth more than $1 million from the United States to China. The man was arrested as part of Operation Crash, a continuing investigation by the Service to detect, deter and prosecute those engaged in the illegal killing of rhinoceros and the unlawful trafficking of rhinoceros horns.
News Release
Two Years in Prison for Smuggler of Cups Made from Rhino Horn
U.S. Department of Justice
Represents Largest-Ever Criminal Foreign Bribery Fine
Alstom S.A., a French power and transportation company, was sentenced today to pay a $772,290,000 fine to resolve criminal charges related to a widespread corruption scheme involving at least $75 million in secret bribes paid to government officials in countries around the world, including Indonesia, Saudi Arabia, Egypt, the Bahamas and Taiwan.
Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, First Assistant U.S. Attorney Michael J. Gustafson the District of Connecticut and Assistant Director in Charge Paul M. Abbate of the FBI’s Washington Field Office made the announcement.
Alstom was sentenced by U.S. District Judge Janet Bond Arterton of the District of Connecticut. Alstom pleaded guilty on Dec. 22, 2014, to a two-count criminal information charging the company with violating the Foreign Corrupt Practices Act (FCPA) by falsifying its books and records and failing to implement adequate internal controls.
In addition, Alstom Network Schweiz AG, formerly Alstom Prom AG (Alstom Prom), Alstom’s Swiss subsidiary, which pleaded guilty on Dec. 22, 2014, to a criminal information charging the company with conspiracy to violate the anti-bribery provisions of the FCPA, was also sentenced today pursuant to its plea agreement. Alstom Power Inc. and Alstom Grid Inc., formerly Alstom T&D Inc., two U.S. subsidiaries, both entered into deferred prosecution agreements on Dec. 22, 2014, admitting that they conspired to violate the anti-bribery provisions of the FCPA.
According to the companies’ admissions, Alstom, Alstom Prom, Alstom Power and Alstom T&D, through various executives and employees, paid bribes to government officials and falsified books and records in connection with power, grid and transportation projects for state-owned entities around the world, including in Indonesia, Egypt, Saudi Arabia, the Bahamas and Taiwan. In Indonesia, for example, Alstom, Alstom Prom and Alstom Power paid bribes to government officials—including a high-ranking member of the Indonesian Parliament and high-ranking members of Perusahaan Listrik Negara, the state-owned electricity company in Indonesia—in exchange for assistance in securing several contracts to provide power-related services valued at approximately $375 million. In total, Alstom paid more than $75 million to secure more than $4 billion in projects around the world, with a profit to the company of approximately $300 million.
Alstom and its subsidiaries also attempted to conceal the bribery scheme by retaining consultants who purportedly provided consulting services on behalf of the companies, but who actually served as conduits for corrupt payments to the government officials. Internal Alstom documents refer to some of the consultants in code, including “Mr. Geneva,” “Mr. Paris,” “London,” “Quiet Man” and “Old Friend.”
The sentence, which is the largest criminal fine ever imposed in an FCPA case, reflects a number of factors, including: Alstom’s failure to voluntarily disclose the misconduct, even though it was aware of related misconduct at a U.S. subsidiary that previously resolved corruption charges with the department in connection with a power project in Italy; Alstom’s refusal to fully cooperate with the department’s investigation for several years; the breadth of the companies’ misconduct, which spanned many years, occurred in countries around the globe and in several business lines, and involved sophisticated schemes to bribe high-level government officials; Alstom’s lack of an effective compliance and ethics program at the time of the conduct; and Alstom’s prior criminal misconduct, including conduct that led to resolutions with various other governments and the World Bank.
After the department publicly charged several Alstom executives, however, Alstom began providing thorough cooperation, including assisting the department’s prosecution of other companies and individuals.
To date, the department has announced charges against five corporate executives for alleged corrupt conduct involving Alstom. Frederic Pierucci, Alstom’s former vice president of global boiler sales, pleaded guilty on July 29, 2013, to conspiring to violate the FCPA and a charge of violating the FCPA for his role in the Indonesia bribery scheme. David Rothschild, Alstom Power’s former vice president of regional sales, pleaded guilty on Nov. 2, 2012, to conspiracy to violate the FCPA. William Pomponi, Alstom Power’s former vice president of regional sales, pleaded guilty on July 17, 2014, to conspiracy to violate the FCPA. Lawrence Hoskins, Alstom’s former senior vice president for the Asia region, was charged in an indictment in connection with the Indonesia bribery scheme, and is pending trial in the District of Connecticut in April 2016. The charges against Hoskins are merely allegations, and he is presumed innocent unless and until proven guilty. The high-ranking member of Indonesian Parliament was also convicted in Indonesia of accepting bribes from Alstom, and is currently serving a three-year prison term. In addition, Marubeni Corporation, which partnered with Alstom on the Indonesia project, pleaded guilty on March 19, 2014 to a criminal information charging conspiracy to violate the FCPA and seven counts of violating the FCPA, and was sentenced on May 15, 2014, to pay an $88 million criminal fine.
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