FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing - Food & Drug Administration
Today (11/8/23), the U.S. Food and Drug Administration (FDA) issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.
MoCRA provided new authorities to FDA including:
• Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
• Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
Exemptions:
MoCRA exempts certain small businesses from facility registration and product listing requirements.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
• Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
• Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
In March 2023, FDA issued a Constituent Update FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP) as a result of the facility registration and product listing authorities mandated by MoCRA.
In August 2023, FDA issued draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.
In September 2023, FDA announced an opportunity to comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. FDA anticipates that electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023.
Delayed Enforcement Announced Today
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
In addition, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.
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Federal Register Notices:
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Common Alloy Aluminum Sheet From Turkey: Final Results of Antidumping Duty Administrative Review; 2020-2022
• Glycine From India: Final Results of Antidumping Duty Administrative Review; 2021-2022
• Certain Activated Carbon From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; and Final Determination of No Shipments; 2021-2022
• Common Alloy Aluminum Sheet From Germany: Final Results of Antidumping Duty Administrative Review; 2020-2022
• Investigations; Determinations, Modifications, and Rulings, etc.: Certain Freight Rail Couplers and Parts Thereof From Mexico
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Fresh Garlic From the People's Republic of China: Preliminary Affirmative Determination of Circumvention
• Certain Hardwood Plywood Products From the People's Republic of China: Notice of Court Decision Not in Harmony With the Final Determination of Antidumping Duty Investigation; Notice of Amended Determination Pursuant to Court Decision; and Notice of Revocation of Antidumping Duty Order, in Part
• Initiation of Antidumping and Countervailing Duty Administrative Reviews
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Multilayered Wood Flooring From the People's Republic of China: Notice of Court Decision Not in Harmony With the Results of Antidumping Administrative Review; Notice of Amended Final Results
• Certain Freight Rail Couplers and Parts Thereof From Mexico: Antidumping Duty Order
• Initiation of Antidumping and Countervailing Duty Administrative Reviews
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Multilayered Wood Flooring From the People's Republic of China: Notice of Court Decision Not in Harmony With the Results of Antidumping Administrative Review; Notice of Amended Final Results
• Certain Freight Rail Couplers and Parts Thereof From Mexico: Antidumping Duty Order
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Paper Shopping Bags From the People's Republic of China: Preliminary Affirmative Determination of Countervailable Subsidies, Preliminary Affirmative Determination of Critical Circumstances, and Alignment of Final Determination With Final Antidumping Duty Determination; Correction
• Investigations; Determinations, Modifications, and Rulings, etc.: Certain Pillows and Seat Cushions, Components Thereof, and Packaging Thereof; Notice of a Commission Determination To Issue a General Exclusion Order, a Limited Exclusion Order, and Cease and Desist Orders; Termination of Investigation
• Silicon Metal From China; Determination
• Certain Mobile Phones, Components Thereof, and Products Containing Same; Notice of Institution of Investigation
• Certain Electronic Devices, Including Mobile Phones, Tablets, Laptops, Components Thereof, and Products Containing the Same; Notice of Institution of Investigation
• Aluminum Lithographic Printing Plates From China and Japan
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From Ship to Shelf, Cargo Movement at the Port of New York and New Jersey Could Mean Unusual Holiday Shopping Season Ahead - Port of NY/NJ
Discounts could be even more plentiful than usual this holiday season for regional shoppers as retailers look to draw down their massive inventory, the result of a frenetic few years at the New York-New Jersey gateway and other ports around the nation.
Santa is putting his elves to work earlier than ever this year.
While the so-called “Christmas creep” phenomenon is an annual topic of debate, this year shoppers may find ample opportunity for ahead-of-schedule holiday shopping with discounts galore. Retailers are predicting an even earlier-than-usual start to the holiday shopping season, at least partially thanks to the unusual shipping trends of the past few years seen at cargo gateways such as the Port of New York and New Jersey leading to some jam-packed warehouses and excess inventory. As a result, retailers may be willing to give deep discounts to see those items finally leave their warehouses.
“The numbers show us that many warehouses are bursting at the seams, and they have been for a while,” said Bethann Rooney, port director at the Port Authority of New York and New Jersey. “That means stores are going to do all they can to make some space, and that includes slashing prices.”
Read entire article here
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Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products - U.S. Food & Drug Administration
Yesterday, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products until they come into compliance with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act.
The U.S. District Court for the District of Utah, Central Division has entered two consent decrees of permanent injunction against Evig LLC, of St. George Utah, and the company’s CEO, Douglas Lex Howard, as well as Premium Production LLC, of St. George, Utah, and its Manager, Ryan Petersen.
Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs. The FDA has not approved Balance of Nature products for any use, despite the company’s claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19. In addition, Evig LLC violated current good manufacturing practice (CGMP) requirements, which rendered its products adulterated dietary supplements. Evig distributes Balance of Nature dietary supplement products through Amazon, Walmart, and its own online store at www.balanceofnature.com.
Premium Production LLC and Mr. Petersen manufactured Balance of Nature products in violation of multiple CGMP requirements, such as failing to establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.
“This FDA action ensures that dietary supplements distributed to American consumers are appropriately labeled, lawfully manufactured, and prevents products that potentially put people’s health at risk with unproven claims to cure, treat or prevent a serious illness,” said Michael C. Rogers, the FDA’s Acting Associate Commissioner for Regulatory Affairs. “We previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements, and the public cannot have confidence that their products are what they purport to be. The FDA will continue to protect the U.S. public health by taking appropriate actions when companies violate the law.”
In 2019, the FDA issued warning letters to Evig LLC and Premium Production LLC after facility inspections identified CGMP violations at both companies’ facilities. The warning letter to Evig LLC also informed the company that a review of its Balance of Nature website revealed that its products as labeled were unapproved new and misbranded drugs because they were intended to cure, mitigate, treat, or prevent disease. Following the 2019 warning letters, FDA inspections showed that the firms failed to address the deviations and come into compliance with the FDA’s requirements. Based on the firms’ continued violations, the FDA pursued injunctions against the firms.
“Products intended to treat or cure diseases require FDA approval,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Dietary supplement makers also must abide by federal health and safety requirements. The Department will continue to work closely with FDA to stop the distribution of unapproved, adulterated, and misbranded dietary supplements.”
The consent decrees prohibit Evig LLC and Premium Production LLC from distributing or manufacturing products until they are in compliance with CGMP and labeling regulations. Under the consent decrees, both firms must hire CGMP experts, submit documents demonstrating compliance, and receive the FDA’s approval to resume operations. In addition, Evig LLC must hire a labeling expert to ensure their products are no longer considered new and/or misbranded drugs.
The U.S. Department of Justice filed the complaints on behalf of the FDA.
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FTC Warns Two Trade Associations and a Dozen Influencers About Social Media Posts Promoting Consumption of Aspartame or Sugar - Federal Trade Commission
Federal Trade Commission staff have sent warning letters to two trade associations and 12 registered dieticians and other online health influencers warning them about the lack of adequate disclosures in their Instagram and TikTok posts promoting the safety of the artificial sweetener aspartame or the consumption of sugar-containing products.
The letters to the trade groups, the American Beverage Association (AmeriBev) and The Canadian Sugar Institute, express concerns that the organizations may have violated the FTC Act by failing to adequately disclose that the influencers were apparently hired to promote the safety of aspartame or the consumption of sugar-containing products, respectively. This action follows FTC’s recent revision of the Commission’s Guides for Endorsements and Testimonials, and is part of the agency’s continued monitoring of influencer marketing.
“It’s irresponsible for any trade group to hire influencers to tout its members’ products and fail to ensure that the influencers come clean about that relationship,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “That’s certainly true for health and safety claims about sugar and aspartame, especially when made by registered dieticians and others upon whom people rely for advice about what to eat and drink.”
The letter to AmeriBev detail concerns about posts on Instagram and TikTok by Valerie Agyeman, Nichole Andrews, Leslie Bonci, Keri Gans, Stephanie Grasso, Cara Harbstreet, Andrea Miller, Idrees Mughal, Adam Pecoraro, and Mary Ellen Phipps, each of whom also received an individual warning letter.
The letter to The Canadian Sugar Institute expresses concerns about Instagram posts by Jenn Messina and Lindsay Pleskot, each of whom also received an individual warning letter.
As discussed in the Commission’s Guides for Endorsements and Testimonials, paid endorsements should clearly and conspicuously disclose any unexpected material connections to ensure that consumers have the information they need to make informed purchasing decisions.
Each of the warning letters identified what appeared to be paid posts that either did not disclose a material connection, or that contained disclosures that may be inadequate. Each letter explained staff’s concerns regarding particular disclosures, including inconspicuous placement, ambiguous language, or the failure to clearly identify the sponsor of the posts.
Each letter also included the FTC’s notice of penalty offenses concerning misleading endorsements and noted that the recipient could face civil penalties of up to $50,120 per violation for future failures to disclose unexpected material connections. Finally, each letter asked the recipient to contact agency staff within 15 days and detail any actions taken or that will be taken to address staff’s concerns.
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Make it a 'Home Safe Home' for the Holidays - Consumer Product Safety Commission
CPSC reports latest injuries from toy hazards; Provides tips to stay safe for the holidays
WASHINGTON, D.C. – A new report from the U.S. Consumer Product Safety Commission (CPSC) is highlighting the importance of safety when buying and playing with kids’ toys – even for older children. CPSC’s Toy-Related Deaths and Injuries report found there were 11 deaths, and an estimated 145,500 emergency department-treated (ED) injuries in 2022 associated with toys for children 12 years and younger.
The majority of the 11 deaths reported were attributed to choking or asphyxiation associated with small parts, balls, or balloons. Among the ED-treated injuries, non-motorized scooters accounted for the largest share of injuries across all age groups – 35,400. Non-motorized scooters accounted for one in every 5 toy-related injuries to children aged 14 and younger.
While the report showed year-over-year shifts in injuries and deaths, CPSC researchers observed a statistically significant downward trend from 2015 to 2022 in toy-related injuries for children 14 years and younger. There was a nearly 12% decrease in the estimate of toy-related ED treated injuries from 2015 (181,600) to 2022 (159,500) for children 14 years and younger whereas children under the age of 13 saw a 16% decrease (173,200 to 145,500).
Consumers should not only “think safety” about what they buy for children but should also be vigilant about where gifts are purchased, especially online. As e-commerce retailing continues to grow year-over-year for holiday sales, Chair Hoehn-Saric is urging caution when turning to online retail outlets.
“Consumers expect the products they purchase online to be as safe as those they buy in brick-and-mortar stores,” Chair Hoehn-Saric said. “While this is true when buying online directly from a manufacturer, purchasing from an online marketplace that services other sellers raises additional risks. Consumers need to educate themselves not only about what they buy, but where and from whom. It’s important not to sacrifice safety.”
CPSC recommends following these tips when purchasing products online:
• Remember that when buying gifts online you could be purchasing directly from a manufacturer, or going through a retailer, or a third-party seller. In each instance, if you have a problem with a product or want to return or exchange it where you purchased the product matters. Look for the “sold by” information when purchasing from an online marketplace.
• Do more than skim product descriptions. Always read to the bottom of the listing or check drop-down menus for additional safety information, especially when shopping for children. Also, read customer reviews to see what other consumers have experienced with the product.
• Look for a certification mark on toys from an independent testing organization on the manufacturer’s label.
• If purchasing second-hand products from an online marketplace, check to see whether products have been recalled before you buy by going to CPSC.gov/recalls.
• Buy from reputable dealers and if the price seems too good to be true, this can be a sign that the product is not authentic or original, and may be unsafe.
CPSC is highlighting the following additional safety tips for safe and happy holiday activities including toy-buying, cooking and decorating.
Toys
Did you know? CPSC, in collaboration with U.S. Customs and Border Protection (CBP), seized more than 1.1 million dangerous or illegal toys in fiscal year 2023. Of those, nearly 101,000 toy seizures were lead related.
• Follow age guidance and other safety information on toy packaging and choose toys that match each child's interests and abilities.
• Get safety gear, including helmets, for scooters and other riding toys–and make sure that children use them every time.
• Keep small balls and toys with small parts away from children younger than age 3 and keep deflated balloons away from children younger than age 8.
• Once the gifts are open, immediately discard plastic wrappings or other packaging on toys before they become dangerous playthings.
Cooking
Did you know? Cooking is the leading cause of residential fires, according to CPSC's report on Residential Fire and Loss Estimates. Of the 360,800 home fires every year, cooking fires account for nearly half of these. Thanksgiving Day is the peak day for cooking fires, with an average of 1,600 cooking fires occurring on this day – more than three times the daily average of cooking fires. CPSC data also shows that Black Americans have the highest rate of deaths from fire, nearly twice the overall rate across the population.
CPSC recommends following these tips for safe and fire-free holiday cooking:
• Never leave cooking food unattended on the stove or in the oven.
• Only fry a turkey outside and away from your home or other flammable materials. Never use turkey fryers in an enclosed area like the garage or on the porch.
Holiday Decorations
Did you know? On average, there are about 160 Christmas decorating-related injuries each day during the holiday season, with over 40% of the incidents involving falls. In the 2022 holiday season (Nov 1, 2021 - Jan 31, 2022), about 14,800 people were treated in hospital emergency departments due to holiday decorating-related injuries.
Keep holiday decorating merry, bright, and safe with these tips:
• Make sure your live Christmas tree has plenty of water and look for the “Fire Resistant” label when buying an artificial tree.
• Never leave candles unattended. Place burning candles in sight, away from flammable items, and blow or snuff them out before leaving the room. Use flameless candles whenever possible.
• Never string together more than three sets of incandescent lights, and never overload electrical outlets.
Visit CPSC’s Holiday Safety Information Center for more holiday safety tips, as well as a sharable Holiday Safety video, poster and b-roll that show the serious risks posed by using a turkey fryer too close to the home, a dry Christmas tree, and burning candles near flammable items.
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HSN Agrees to Pay $16 Million Civil Penalty for Failure to Immediately Report Serious Burn Hazard Posed by Clothing Steamers - Consumer Product Safety Commission
WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is announcing that HSN Inc., of St. Petersburg, Florida, has agreed to pay a $16 million civil penalty. The settlement, which has been provisionally accepted by CPSC, resolves CPSC’s charges that HSN knowingly failed to immediately report to CPSC, as required by law, that its Joy Mangano-brand My Little Steamer and My Little Steamer Go Mini contained a defect that could create a substantial product hazard or created an unreasonable risk of serious injury to consumers.
By the end of 2012 and continuing into 2019, HSN received numerous reports that the steamers would spray, expel, and/or leak hot water while in use, resulting in serious and permanent injuries, a limited number of which constituted grievous bodily injury. Despite possessing information that reasonably supported the conclusion that the steamers contained a defect that could create a substantial product hazard or created an unreasonable risk of serious injury, HSN did not immediately report to the Commission. By the time HSN filed an initial report with the Commission, HSN had received approximately 400 complaints of the steamers spraying or expelling hot water and approximately 700 additional reports of leaks, resulting in at least 91 reports of injury and 29 insurance claims alleging injuries, including reports of second and third-degree burns, scarring and one report of partial hearing loss. In addition, from information in HSN Online Reviews, HSN had knowledge of approximately 500 complaints of the steamers spraying or expelling hot water and approximately 150 complaints of leaks, including 87 reports of injury. HSN and the Commission jointly announced a recall of the steamers on May 26, 2021.
In addition to the $16 million penalty, the settlement agreement requires HSN to maintain internal controls and procedures designed to ensure compliance with the Consumer Product Safety Act, including enhancements to its compliance program. HSN has also agreed to submit, for a period of three years, annual reports regarding its compliance program, internal controls, and internal audits of the effectiveness of compliance policies, procedures, systems, and training.
By a 4 to 0 vote, the Commission provisionally accepted the settlement agreement, subject to public comment. Elizabeth L. Jones, a Trial Attorney in the Division of Enforcement and Litigation, represented the Commission in this enforcement action