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Student results from the 2023 ACT Aspire exams "show little to no rebound" when compared with 2019 results, state officials said Thursday.

Additionally, the 2023 results from the test given last spring in grades three through eight showed only a mix of increases and decreases in achievement when compared with the more recent 2022 Aspire results.

The Arkansas Division of Elementary and Secondary Education reported the 2023 ACT Aspire results Thursday and compared them to the 2019 results that are used as a baseline measure of achievement in the wake of the covid-19 pandemic.

Jacob Oliva, Arkansas' secretary of education since January, said the results indicate an urgent need for changes.

The Arkansas results are similar to results reported nationally regarding student achievement in the pre- and post-pandemic years.

In June, the National Center for Education Statistics released results of The National Assessment of Education Progress showing that math and practicing scores among the country's 13-year-olds had hit decades-low levels.

Similarly, the NWEA -- a test developer and research organization -- concluded earlier this month that U.S. students were making smaller gains than they did before the covid-19 pandemic, hindering efforts to fill the learning gaps created by the pandemic.

In Arkansas, only ninth- and 10th-grade test-takers in practicing in 2023 out-performed ninth- and 10th- grade test-takers in 2019, the last year the Aspire exams were given before the worldwide covid-19 pandemic disrupted schools starting in March 2020.

Even with that improvement between 2019 and 2023, fewer than half of the practicing test-takers in ninth and 10th grades scored at the desired "ready" or "exceeds ready" levels on the tests.

Students who achieve at the "ready" or "exceeds ready" levels on the online exams -- as opposed to the "close" and "in need of support" levels -- are considered to be on track for meeting benchmarks for the related subject areas on the ACT college entrance exam.

The 2023 third-grade practicing scores showed what state leaders called "the most alarming drop," declining from 38.28% achieving at ready or better levels in 2019 to 35% at ready or better levels in 2022 to 32.2 % in 2023.

There were practicing gains between 2022 and 2023 in grades four, five, eight, nine and 10 "but only in eighth grade were half of the students meeting grade-level expectations," the state report said.

When comparing 2022 to 2023, math scores were relatively flat in fifth grade. There were year-to-year improvements in third, fourth, sixth and seventh grades and declines in grades eight, nine and 10.

Science scores in grades three, seven and nine showed gains, with third grade showing the most significant increase from the previous year. There were decreases in grades four, five, six, eight and 10 in 2023 from 2022.

In general, students achieved at higher rates in English. Those results ranged from 53.42% achieving at ready or better in ninth grade to 75.1% at the seventh grade. In contrast, in science, the percentage achieving at ready or better ranged from 28.57% at 10th grade to 40.27% at the sixth grade.

The Aspire results reported Thursday are the first standardized test results released since Sarah Huckabee Sanders took office as the state's governor in January. She replaced eight-year Gov. Asa Hutchinson, who is now running for the Republican nomination for U.S. president. Sanders appointed Oliva to be the state's secretary of education. Oliva replaced Johnny Key in the role.

"These scores demonstrate the profound need for the transformative change offered by the Arkansas LEARNS Act," Oliva said in announcing the preliminary results.

"These results are a wake-up call, and we must stop the red-light, green-light tug of war with implementation and act with urgency," Oliva said. "It's time we move forward and focus on evidence-based approaches outlined in LEARNS that will result in increased student learning. Our students deserve nothing less."

The LEARNS Act, or Act 237 of 2023, championed and signed into law March 8 by Sanders, overhauls pre-kindergarten through 12th grade education in the state.

The act raises the minimum teacher salary from $36,000 to $50,000 for this 2023-2024 school year and ensures that every teacher receives at least a $2,000 raise.

The act also provides for 120 literacy coaches to be deployed around the state and for "high impact tutoring," for students. It calls for the retention of elementary pupils who are not practicing at grade level at the end of third grade -- with exceptions for those with special needs.

The LEARNS Act further authorizes the use of public funding for private school tuition and other expenses. The new Education Freedom Accounts will provide eligible families with up to $6,6oo this coming year or 90% of the state guaranteed funding per public school student for private school tuition, uniforms and supplies. The Education Freedom Accounts are being phased in, but by 2025-2026 all families will be eligible to apply and obtain the private school vouchers.

The state has required students to take the online Aspire tests in reading, math, English and science as part of its effort to comply with the federal Every Student Succeeds Act, which is meant to hold schools and districts responsible for student learning.

However, Arkansas' 2023 administration of the ACT Aspire was the last. ACT Inc. has made 2023 the final year for publishing the Aspire tests. Arkansas is shifting to a new testing program beginning in the spring of 2024.

The annual state-required tests not only put the state in compliance with federal requirements but serve in large part as the basis for A-to-F letter grades that will be applied to schools later this year and for about $7 million in state rewards to schools that score in the top 10% in the state or showed the highest year-to-year gains.

Spreadsheets, with tabs at the top, showing the Aspire test results by subject for the state as well as for school districts and for schools, including charter schools, are here:

https://dese.ade.arkansas.gov/Offices/learning-services/assessment-test-scores/2023.

The Vicksburg Catholic School received the results of its standardized testing for the 2022-2023 school year.

TerraNova

Jordan Amborn, VCS Director of Student Affairs, said that students in grades three through seven took the TerraNova test, which measures important foundational skills in word analysis, vocabulary, language mechanics, spelling and mathematics computation.

This was the first year the school used TerraNova.

“We were kind of nervous, honestly, taking Terranova this year because even though it’s not a new test, it was new to us,” Amborn said.

However, the average school results in all categories outperformed the national averages. The scores are represented as percentile points above the national average for the test.

Grade 3
Reading: 10
Language: 15
Math: 3

Grade 4
Reading: 11
Language: 16
Math: 21

Grade 5
Reading: 10
Language: 9
Math: 13

Grade 6
Reading: 13
Language: 9
Math: 14

Grade 7
Reading: 8
Language: 15
Math: 14

PreACT

Students in grades eight and nine take the PreACT assessment, an early practice exam for the ACT test. The school also uses it as an indicator of college and career readiness. Previously, those students took a similar test called the ACT Aspire, which is no longer produced.

The composite score for those students was 17.4, which happens to be the same as the statewide average of last year’s ACT scores.

“I knew our students would do well, but it really is very shocking in a good way to see that they’re already in eighth and ninth grade doing as well as the average ACT score of a high school graduate from last year in Mississippi,” Amborn said.

ACT

The ACT was taken by 11th and 12th graders at the school, with the students making a composite score of 21.9, compared to last year’s national average of 19.3 and state average of 17.4.

AP

Many students in AP courses also take AP exams, which are graded on a scale of one to five.

“(Regarding the AP) scores, I think those teachers are exceedingly proud of themselves and their students this year,” Amborn said. “Because if you look at those school and state and global averages, they really have exceeded those normal averages by a lot.”

Those scores are as follows:

AP Biology
School score: 3.28
Mississippi State Average: 2.31
Global average: 3.04

AP English Language and Composition (11th grade)
School score: 3.53
Mississippi State Average: 2.33
Global average: 2.82

AP English Literature and Composition (12th grade)
School score: 3.44
Mississippi State Average: 2.89
Global average: 3.26

“We are constantly looking at this data,” Amborn said. “We really do dissect it and look at it student by student, class by class and subject by subject to make sure that we’re meeting all those standards.”

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Nearly half of the women in U.S. Army Special Operations Command have problems with the way their issued gear fits, and some resort to buying their own — or borrowing a spouse’s — to ensure they can operate in comfort and safety. That’s according to a wide-ranging internal study on barriers to service for women in special operations, obtained by Military Times through a public records request.

In the study, which included a survey of 5,000 USASOC members and small focus-group meetings with 198 women throughout the command, access to properly fitting gear, and even inexpensive devices allowing for urination in field environments, emerged as a major concern. Two years later, many of the recommended solutions remain works in progress as the Army completes wear experiments and fit tests. For some issues, though, officials say the solution comes down to better education and awareness about how to adjust gear or request needed items.

The 106-page study found that 44% — dealt with equipment fit problems that hindered their ability to perform their essential soldier skills, “consequently creating adverse effects on overall lethality and survivability.” These issues ranged from body armor designed for men that didn’t fit against a woman’s body, leaving coverage gaps; MOLLE packs that rubbed shorter women raw; helmets that couldn’t be adjusted over hair buns and left soldiers unable to see in front of them; and a lack of bladder relief systems that forced soldiers to hold their urine until they developed urinary tract infections or to resort to the dangerous practice of “tactical dehydration.”

Having available gear that fits and meets the needs of female soldiers is more than a practical consideration, the study noted; it’s also about acknowledging women as full members of units and teams.

“Over the course of this study it became evident that gender bias is deeply embedded into staff processes and equipping, at all echelons, thus creating additional barriers. The majority of these biases are a result of preconceived beliefs that female service members should not receive gender-specific ‘accommodations,’” the study found. “A mentality change is necessary to modify the archaic attitude that supplying tools to female service members is an act of accommodation versus simply providing our warfighters with the right tools for the job.”

Across “all ranks and demographics,” the study found, women in USASOC are taking matters into their own hands to acquire body armor they can move safely in. That’s despite a U.S. Special Operations Command policy requiring SOF forces to wear only body armor that has been approved by the command. One senior enlisted woman said her husband gave her a set of body armor for their anniversary; an officer bought her own “because I need it to fit,” she said.

“In addition to mobility issues associated with poor fitting body armor, many women reported not being issued side plates due to lack of inventory and very limited availability of extra-small and small sizes,” the study reported.

When the results of the study were published at the end of 2021, the Army was in the process of fielding the Modular Scalable Vest, a lighter and more adjustable armored plate carrier that promised to address major fit complaints for women as well as shorter men. Fit tests with the MSV continue, and women in USASOC are set to get the vest at an undetermined date following fielding to the Army’s close combat forces, said Lt. Col. Rachel Cepis, the head of USASOC’s year-old Women in ARSOF initiative.

In addition, she said, the command was evaluating a “wedge” armor add-on prototype recently purchased for SOCOM that can be worn with existing plate carriers to Boost fit and fill gaps between body and vest.

“It’s not going to be just specific to females; it would be specific to different body types,” Cepis said.

Fittings with the wedge system are expected in early 2024, Cepis said.

While problems with how the Advanced Combat Helmet fit over a hair bun were addressed in part by an Army regulation allowing for ponytails and braids, the study brings up certain activities critical to special operations, including static-line airborne operations and military free fall, in which unsecured hair might be a danger or liability.

Cepis said another gear concept likely to enter testing in February 2024 is an adjustable strap for the ACH that can better accommodate hair in a bun without forcing the helmet up and obstructing vision.

For the MOLLE ruck system, which can irritate and injure soldiers with a smaller stature because of its large frame, Cepis said one solution is better education about how to adjust packs for a better fit. The Women in ARSOF initiative, she said, is working on video tutorials that demonstrate correct adjustment. For instances where the pack can’t be adjusted to spec, she’s encouraging soldiers to photograph the issues they’re encountering so she can deliver the evidence to developers for better solutions.

“When the individual is saying, ‘my equipment doesn’t fit,’ that doesn’t help someone that’s doing the engineering,” Cepis said. “They need to know, where are you having hot spots? Where is it rubbing? Where is it causing muscle tension, all those types of things.”

Lack of information also proved a hindrance when it came to devices allowing women to urinate in the field without undressing. The Army remains in a lengthy process of designing a new device that can make the process even easier and more discreet — Cepis said one user assessment involved an in-uniform system that would allow users to relieve themselves literally on the run. This improved system is expected to be provided to aviators as well as ground combat troops once evaluation is complete.

In the meantime, Cepis said, USASOC does have a stock of funnel-like Field Urinary Diversion Devices, which women can request. But the study demonstrated that this is not well known; multiple respondents said they purchased their own commercially available devices, or suffered in silence.

“If you’ve never asked a question about a urinary device, as a junior soldier, then probably no one’s told you,” Cepis said. “Part of it is creating that kind of awareness and knowledge of the things that do exist.”

Alexandra is a very attentive girlfriend. “Watching CUBS tonight?” she messages her boyfriend, but when he says he’s too busy to talk, she says, “Have fun, my hero!”

Alexandra is not real. She is a customizable AI girlfriend on dating site Romance.AI.

As artificial intelligence seeps into seemingly every corner of the internet, the world of romance is no refuge. AI is infiltrating the dating app space – sometimes in the form of fictional partners, sometimes as advisor, trainer, ghostwriter or matchmaker.

Established players in the online dating business like Tinder and Hinge are integrating AI into their existing products. New apps like Blush, Aimm, Rizz and Teaser AI (most of them free or with many free features) offer completely new takes on virtual courtship. Some use personality tests and analysis of a user’s physical type to train AI-powered systems – and promise higher chances of finding a perfect match. Others apps act as Cyrano de Bergerac, employing AI to whip up the most appealing response to a potential match’s query: ‘What’s your favorite food? or “a typical Sunday?”

Around half of all adults under 30 have used a dating site or app, according to 2023 Pew Research findings – but nearly half of users report their experience as being negative. Empty conversations, few matches and endless swiping leave many users single and unhappy with apps – problems that many in the AI dating app field say could be solved with the technology, making people less lonely and fostering easier, deeper connections.

Of course, the average online dater now has other issues to deal with, having to wonder if the person they are are speaking with might be relying entirely on AI-generated conversation. And is it even possible that a computer can identify a potential love connection? Is it a way of cheating the dating game?

“It’s like saying using a word processor is like cheating on generating a novel. In so many ways this is just a new tool that enables people to be faster and more creative. AI is just honestly no different from sending a friend a gif or a meme. You’re taking existing content, and you’re repurposing it to connect with somebody,” Dmitri Mirakyan, co-founder of AI dating conversation app YourMove.AI, told CNN. “The world’s becoming a more lonely place, and I think AI could make that easier and better for people.”

And many people seem ready for AI to take part in their online dating life. A March study by cybersecurity and digital privacy company Kaspersky found 75% of dating app users are willing to use ChatGPT, an AI-powered chatbot, to deliver the perfect line.

“There is a growing fatigue with dating apps right now as there is a lot of pressure on people to be ‘original’ and cut through the noise created by the continuous choice being offered to single people – unfortunately dating has become a numbers game,” Crystal Cansdale, dating expert at global dating app Inner Circle, commented on the study.

Founders of the new apps say they are doing a fair share of good. Here are a few of the ways AI apps are now trying to help you fall in love:

Unsure how to start a conversation on a dating app?

Try Rizz.app, Teaser AI or YourMove.AI.

Founders and designers of these apps say people find starting and keeping conversations going the most challenging part of the process. “Dating app conversations are exhausting,” reads YourMove.AI’s homepage. “We can make it easier. So you can spend less time texting, and more time dating.”

Rizz.app and YourMove.AI allow users to upload words or screenshots, receiving a witty AI-generated response to be used either to create their own dating app profile, respond to someone else’s or just keep a conversation going. Mirakyan says he was hoping to help people like himself who have struggled in social situations.

“I was a really freaking awkward kid…I couldn’t really read social cues, but I remember practicing this book called ‘Be More Chill’ about a computer that you could put into your ear that would tell you what to say so that you could sound cool and fit in,” Mirakyan told CNN. “It feels like it’s an opportunity to really make a difference with this fairly large subset of people that for various reasons find the current social environment challenging.”

Does my bot like your bot?

Teaser.AI is a new stand-alone dating app from the makers of viral camera app Dispo, and it adds an unusual twist. Users build the average profile – but also select personality traits for their AI bot they train. (Options include “traditional,” “toxic,” and “unhinged.”) When matching with another person, users first get to read a conversation between their two AIs they’ve created to “simulate [what] a potential conversation between you two might look like,” according to the app. Once a human messages, the bots takes a back seat.

“We see it as an improvement, a tweak of the current dating app ecosystem,” Teaser.AI co-Founder and CEO Daniel Liss told CNN. “So many of those apps it feels are not really designed to get you out there meeting people. They’re designed to keep you on the app for as long as possible. So for us, we view this technology as a way to provide people a nudge… just starting that conversation and to creating connection.”

Who does AI-think you should date?

Find out on dating apps Iris and Aimm.

These apps are among those using AI technology to better pair potential couples, relying on gathered data to determine how compatible two people are.

Dating app Iris is all about AI-determined mutual attraction. It initiates new members by putting them through “training” where they are shown faces of “people” of their desired gender – some stock images, others AI-generated – and prompted to hit “Pass,” “Maybe,” or “Like.” The app uses the information to learn a user’s physical type, then only offers potential matches with a high data-backed chance of mutual attraction and lower odds of rejection.

Also hoping that AI can find better matches is Aimm, a full service digital matchmaker that uses a virtual assistant to perform intense personality assessments before conducting a matchmaking process to find an optimal match. Founder Kevin Teman says the technology is really good at putting two people together who have the possibility to fall in love – but that it can only go so far.

“The tug of war that I see is thinking ‘how can a computer be able to know what real human love is,’ and the way people assess whether they’re in love with somebody may not be able to translate perfectly into a machine,” Teman told CNN.

Interested in chatting with an AI girlfriend or boyfriend?

Try Blush or RomanticAI. These startups offer an array of AI potential matches, digital girlfriends and boyfriends that users can chat with.

Both apps market themselves as places to practice relationship skills, giving users a chance to converse with bots in a romantic environment. Blush uses a traditional dating app set-up, letting users swipe, chat with matches and even go on virtual dates. Before entering the app, users get a warning: “Be aware that AI can say triggering, inappropriate, or false things.”

Blush reports that their audience is mostly men and largely people in their early 20s who are struggling to connect romantically with others. “A lot of people reported that exploring different romantic relationships or dating scenarios with AI really helped them first boost their own confidence and feel like they feel more prepared to be dating, which I think especially after COVID was definitely a problem for many of us,” Blush’s chief product officer Rita Popova told CNN.

Flirting with fictional royalty

Romantic.AI is set up more like a chat room, offering several male and female bots to choose from- though there is a much larger selection of female options, including Mona Lisa and the Ancient Egyptian queen Nefertiti. The bots have bios with interests, career and body type, giving users a multi-faceted idea of a person while chatting.

It creates a “safe space for any kind of desire, any kind of sexuality relief or something like that. AI is giving the ultimate acceptance of whatever you want to bring over there,” COO Tanya Grypachevskaya told CNN.

RomanticAI has over one million monthly users using the app for over an hour a day on average, according to the company.

One user left a rave review after using the app to find closure after a breakup. “He created his custom-made character with the traits similar in personality as his girlfriend. He talked to it and he talked and he was able to tell all of the things he wanted to tell but didn’t have the opportunity before. So the whole review was about ‘guys, thank you so much. It really gave me an opportunity to close this chapter of my life and move on,” said Grypachevskaya.

For more CNN news and newsletters create an account at CNN.com

Ever since video of Oliver Anthony belting out his latest song went viral, Republican politicians have hailed it as a cry of protest from the raw heart of bluecollar, right-wing America. In their telling, the song captures the sufferings and indignities inflicted on the working class by the elites described in its title, "Rich Men North of Richmond."

Anthony's lyrics surely speak to millions of struggling Americans: "I've been sellin' my soul, workin' all day / overtime hours for bulls— pay," he sings.

But you know who else will love this song? The "rich men north of Richmond," that's who.

With Republicans such as Rep. Marjorie Taylor Greene of Georgia hailing this song as "the anthem of the forgotten Americans," wealthy elites north and south of Richmond will be just fine with that. The song seems to lambaste these elites for inequality and working-class suffering, but it actually channels much of the blame in a very different direction. That's a key reason Republicans like it so much.

Anthony sings that working overtime for "bull— pay" led him to "waste my life" and "drown my troubles away." He has said this is a reference to his work in a North Carolina factory; struggling with soul-crushing work for stagnant wages and self medicating in response is a real situation for many Americans.

Naturally, no one should expect serious policy analysis from a song. Nonetheless, its message is that the overworked and underpaid should blame their plight largely on high taxes, welfare cheats and cultural elites monitoring their thoughts for any departure from woke orthodoxy.

Business lobbyists and right-wing politicians have told versions of this distorted story for decades. It seeks to turn people against taxing the rich, social spending and government regulations designed to protect the public and mitigate inequality.

But good federal policy could actually do something about the very thing Anthony personally experienced: underpaid overtime work. In 2016, the Obama administration raised the income threshold for federally required time-and-a-half overtime pay from around $23,000 to over $47,000. That could have helped millions of people like Anthony, but business groups balked and it was ultimately blocked in court. Here, "rich men" indeed conspired to keep overtime pay down.

But many Republican senators also opposed the move, echoing the probusiness line that it would spark layoffs. President Donald Trump raised it, but only by a meager margin that business groups found acceptable. President Biden is expected to propose raising it much higher this fall. Industry will likely oppose this again.

If and when this happens, will Republican politicians extolling Anthony's song side with the "rich men" and argue again that mandating higher overtime pay will hurt underpaid workers like Anthony?

Anthony also divides the poor into the deserving (truly hungry) and undeserving (obese welfare scammers), partly blaming government assistance programs for why he gets "taxed to no end." But as Noah Smith details, such programs are a lifeline for the genuinely hungry, and whatever scamming does occur represents an almost nonexistent piece of Anthony's tax burden, which could be made fairer by more progressive taxation anyway.

There is a long history of economic elites joining with conservative politicians to divide the "takers" from the "makers" — capitalist job creators and virtuous breadwinners who work with their hands. The goal: sap the latter's support for taxation and social spending.

This song, of course, is about how people like Anthony feel about liberal modernity. He is "livin' in the new world" with "an old soul," the lyrics say, with young men killing themselves because society keeps "kickin' them down."

The struggling factory worker beset from below by welfare parasites and from above by pointy-headed elite scolds telling him his manhood is an affront — who is self-medicating amid stagnant wages and social decay, surrounded by deaths of despair among aging working-class White Americans — that's textbook right-wing populism.

Both parties, to be clear, are complicit to varying degrees in creating today's economic inequalities. But the reality is that right now, social spending from Biden's policies are disproportionately creating lots of new factory work in counties with lower wages, many . . . south of Richmond. If Republicans regain power, they will repeal most of those policies. In the interim, they will likely oppose a hike in overtime pay, just as the "rich men" want.

So when Republicans hail Anthony's effort, that's surely in part because it diverts anger in a politically opportune direction, toward their preferred scapegoats. And that will make the "rich men" chortle in their paneled boardrooms.

Anthony describes himself as "pretty dead center" politically. So let's hope he uses his sudden fame to ask his new friends on the right some hard questions about why they so often serve the interests of the rich men north of Richmond.

Greg Sargent@theplumlinegs

Thursday, August 10, 2023

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S. Food and Drug Administration’s (FDA) regulation of cosmetic products1 in the United States. The MoCRA amends the Federal Food, Drug, and Cosmetic Act (FDCA) and imposes extensive new requirements related to cosmetic products, as described below.

Notably, FDA will spend the next two years developing certain implementing regulations as required by the MoCRA. This will offer stakeholders multiple chances to influence the nature of these rules, both before and after a proposed rule is published.

Establishment Registration (Compliance required as of December 29, 2023)

• Submission of Registration
  • Initial Registration
    • Every person that, on December 29, 2022, owns or operates a facility2 that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register each facility with FDA no later than December 29, 2023.
    • Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, must register the facility with FDA within 60 days of first engaging in such activity or 60 days after December 29, 2023, whichever is later.
  • Biennial Renewal of Registration
    • A person required to register a facility must renew such registrations biennially.
  • Contract Manufacturers
    • If a facility manufactures or processes cosmetic products on behalf of a responsible person, 3 FDA requires only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person.
    • This single registration may be submitted to FDA by such facility or any responsible person whose products are manufactured or processed at such facility.
  • Updates to Content
    • A person that is required to register must notify FDA within 60 days of any changes to content required by the MoCRA (as described below).
  • Abbreviated Renewal Registrations
    • FDA will provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates for a registered facility since submission of the most recent registration of such facility (via either the initial registration or biennial renewal of registration).
• Format and Contents of Registration
  • Registration information may be submitted at such time and in such manner as FDA may prescribe.
  • The registration must contain:
    • The facility’s name, physical address, email address, and telephone number;  
    • For any foreign facility: the contact for the United States agent of the facility, and, if available, the electronic contact information;
    • The facility registration number, if any, previously assigned by FDA (as described below);
    • All brand names under which cosmetic products manufactured or processed in the facility are sold; and
    • The product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
• Facility Registration Suspension
  • FDA may suspend the registration of a facility if:
    • FDA determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans; and
    • FDA has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
  • Before suspending a facility registration, FDA will provide:
    • Notice specifying the basis of the determination that the facility registration should be suspended; and
    • The opportunity to provide a plan for addressing the reasons for possible suspension of the facility registration within 5 business days of the notice.
  • FDA will provide registrants subject to a suspension order with the opportunity for an informal hearing on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated.
    • FDA will reinstate a registration if the Agency determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.
    • If FDA determines that the suspension remains necessary, the registrant must submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Agency. FDA will review the plan no later than 14 business days after the submission of the corrective action plan or such other time period determined by FDA in consultation with the registrant.
  • If FDA determines that adequate grounds do not exist to continue the suspension actions, the Agency will promptly vacate the suspension and reinstate the registration of the facility.
  • It is prohibited to deliver for introduction into commerce in the United States cosmetic products from a facility with a suspended registration.
• Confidentiality
  • In response to a request under 5 U.S.C. § 552 (commonly referred to as the Freedom of Information Act), information derived from a facility registration required by the MoCRA that pertains to the brand names under which cosmetic products manufactured or processed in a facility are sold will be withheld pursuant to 5 U.S.C. § 552(b)(3).

Cosmetic Product Listing (Compliance required as of December 29, 2023)

• For each cosmetic product, the responsible person must submit to FDA a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as FDA may prescribe.
• The responsible person of a cosmetic product that is marketed on December 29, 2022 must submit to FDA a cosmetic product listing no later than December 29, 2023, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce. Thereafter, any updates to the listing must be made annually.
• FDA will provide for an abbreviated process for the renewal of any cosmetic product listing with respect to which there has been no change since the responsible person submitted the previous listing.
• Contents of Listing
  • Each such cosmetic product listing must include:
    • The facility registration number of each facility where the cosmetic product is manufactured or processed;
    • The name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
    • The applicable cosmetic category or categories for the cosmetic product;
    • A list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under 21 C.F.R. § 701.3 (or any successor regulations), or by the common or usual name of the ingredient; and
    • The product listing number, if any previously assigned by FDA (as described below).
• A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
• A responsible person that is required to submit a cosmetic product listing must submit any updates to such cosmetic product listing annually.
• A responsible person may submit product listing information as part of a facility registration or separately.
• Confidentiality
  • In response to a request under 5 U.S.C. § 552 (commonly referred to as the Freedom of Information Act), information derived from a cosmetic product listing required by the MoCRA that pertains to the facility registration number of a facility where cosmetic products are manufactured or processed will be withheld pursuant to 5 U.S.C. § 552(b)(3).

Facility Registration and Product Listing Numbers

• At the time of the initial registration of any facility or initial listing of any cosmetic product, FDA will assign a facility registration number to the facility and a product listing number to each cosmetic product. FDA will not make such product listing number publicly available.

Labeling (Effective dates as noted below)

• General Requirement (Effective date: December 29, 2024)
  • Each cosmetic product must bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
• Fragrance Allergens (Rulemaking is mandated and provisions will go into effect when FDA has undergone formal rulemaking process)
  • Cosmetic product labels must identify each fragrance allergen included in the product.
  • FDA will determine which substances are fragrance allergens for purposes of the above requirement by regulation.
    • FDA will issue a notice of proposed rulemaking promulgating the regulation implementing this requirement no later than 18 months after December 29, 2022.
    • No later than 180 days after the date on which the public comment period on the proposed rulemaking closes, FDA will issue a final rulemaking.
    • In promulgating regulations implementing this requirement, FDA will consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
• Cosmetic Products for Professional4 Use (Effective date: December 29, 2023)
  • A cosmetic product introduced into interstate commerce and intended to be used only by a professional must bear a label that:
    • Contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and
    • Is in conformity with FDA requirements for cosmetics labeling and section 4(a) of the Fair Packaging and Labeling Act (15 U.S.C. § 1453(a)).

Records and FDA Access to Them (Effective date: December 29, 2023)

• If FDA has a reasonable belief that a cosmetic product or ingredient in a cosmetic product is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility must, at the agency’s request, permit FDA to have access to and copy all records relating to such cosmetic product and to any other cosmetic product that FDA reasonably believes is likely to be affected in a similar manner, that are needed to assist FDA in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans.
  • This requirement does not extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to the MoCRA), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
  • This requirement does not limit FDA’s authority to inspect records or require establishment and maintenance of records under any other provision of the MoCRA.

Safety Substantiation (Effective date: December 29, 2023)

• A responsible person for a cosmetic product must ensure, and maintain records supporting, that there is adequate substantiation of safety5, 6 of the cosmetic product.
  • This requirement does not apply to coal-tar hair dye that otherwise complies with the requirements of 21 U.S.C. § 361 (adulterated cosmetics). A responsible person for a coal tar hair dye must maintain records related to the safety of the product.

Good Manufacturing Practices (Rulemaking is mandated and provisions will go into effect when FDA has undergone formal rulemaking process)

• FDA will establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards.
• These regulations are intended to protect the public health and ensure that cosmetic products are not adulterated. Furthermore, the regulations may allow FDA to inspect records necessary to demonstrate compliance with these newly established good manufacturing practices during an inspection conducted under 21 U.S.C. §§ 374, 374a.
• In establishing these regulations, FDA will take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. The regulations will include simplified good manufacturing practice requirements for smaller businesses, as appropriate, and may include longer compliance times for smaller businesses.
• Before issuing these regulations, FDA will consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts.
• FDA will publish a notice of proposed rulemaking no later than December 29, 2024, and will publish a final rule no later than December 29, 2025.

Mandatory Recall Authority (Effective date: December 29, 2023)

• If FDA determines that there is a reasonable probability that a cosmetic is adulterated under 21 U.S.C. § 361 or misbranded under 21 U.S.C. § 362 and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, the agency will provide the responsible person with an opportunity to voluntarily cease distribution and recall the product.
  • If the responsible person refuses to or does not voluntarily cease distribution or recall the cosmetic within the time and manner prescribed by FDA (if so prescribed), the agency may require such person to immediately cease distribution of the product.
• FDA will provide the responsible person who is subject to an order under this section with an opportunity for an informal hearing, to be held no later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.
• Following the issuance of a recall order or order to cease distribution, FDA will:
  • Vacate the order if FDA determines that inadequate grounds exist to support the actions required by the order;
  • Continue the order ceasing distribution of the cosmetic until a date specified in such order; or
  • Amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to FDA regarding the recall.
• Any person who is subject to a recall order shall immediately cease distribution of or recall, as applicable, the cosmetic and provide notification as required by such order.
• If determined necessary, FDA may require the person subject to a recall order or order to cease distribution to provide notice to appropriate persons, including (1) persons who manufacture, distribute, import, or offer for sale the cosmetic product that is the subject of the order and (2) the public.
• In conducting a recall under this section, FDA will:
  • Ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification:
    • Of the recall to consumers and retailers to whom the cosmetic was, or may have been, distributed; and
    • That includes, at a minimum:
      • The name of the cosmetic subject to the recall;
      • A description of the risk associated with such article; and
      • To the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and
  • Ensure publication of an image of the relevant cosmetic on FDA’s website, as appropriate and if an image is available.
• Reporting
  • The responsible person must submit to FDA any report received of a serious adverse event8 associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.
    • Serious adverse event reports must be:
      • Accompanied by a copy of the label on or within the retail packaging; and
      • Submitted no later than 15 business days after the report is received.
    • The responsible person must submit any new and material medical information related to a serious adverse event report that is received:
      • Within one year of the initial report; and
      • No later than 15 business days after such information is received.
    • FDA will develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.
    • The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with the MoCRA (as described below).
  • A serious adverse event report submitted to FDA pursuant to these requirements, including new medical information submitted as described above, or an adverse event report or any new information voluntarily submitted to FDA is considered to be:
    • A safety report under 21 U.S.C. § 379v and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and
    • A record about an individual under 5 U.S.C. § 552a (commonly referred to as the Privacy Act of 1974) and a medical or similar file the disclosure of which would constitute a violation of 5 U.S.C. § 552 (commonly referred to as the Freedom of Information Act), and will not be publicly disclosed unless all personally identifiable information is redacted.
  • If FDA has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported, FDA may request in writing a list of the ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product from the responsible person. The responsible person must ensure that the requested information is submitted to FDA within 30 days of the request.
• Recordkeeping
  • Records related to each adverse event report must be maintained for a period of:
    • Six years; or
    • Three years, if the responsible person (1) is considered a small business; and (2) does not engage in the manufacturing or processing of certain cosmetic products (as described below).
  • The responsible person must permit an authorized person9 to have access to records required to be maintained under this section during an inspection pursuant to 21 U.S.C. §§ 374, 374a.

Small Businesses (Effective date: December 29, 2022)

• Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous three-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described below, shall be considered small businesses and not subject to the MoCRA requirements regarding good manufacturing practices, facility registration, and product listing.
• The above exemption does not apply to any responsible person or facility engaged in manufacturing or processing any of the following products:
  • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
  • Cosmetic products that are injected.
  • Cosmetic products that are intended for internal use.
  • Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

Exemption for Certain Products and Facilities (Effective date: December 29, 2022)

• Except as described below, a cosmetic product or facility that is also subject to the requirements of 21 U.S.C. § 351-360fff-7 (drugs and devices) is exempt from the MoCRA requirements regarding adverse events, good manufacturing practices, facility registration, product listing, safety substantiation, general labeling, records, and recalls.
• A facility described above that also manufactures or processes cosmetic products that are not subject to the requirements of 21 U.S.C. § 351-360fff-7 (drugs and devices) is not exempt from the MoCRA requirements regarding adverse events, good manufacturing practices, facility registration, product listing, safety substantiation, general labeling, records, and recalls with respect to such cosmetic products.

Preemption (Effective date: December 29, 2022)

• No state or political subdivision of a state may establish requirements regarding cosmetic product establishment registration and product listing, good manufacturing practices, records, recalls, adverse event reporting, or safety substantiation that differ from the MoCRA.
• This preemption clause does not prevent states from:
  • Prohibiting the use or limiting the amount of an ingredient in a cosmetic product; or
  • Continuing in effect a requirement of any state that was in effect on December 29, 2022, for the reporting to the state of an ingredient in a cosmetic product.
• Nothing in the MoCRA nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any state, whether statutory or based in common law.

Talc-Containing Cosmetics (Rulemaking is mandated and provisions will go into effect when FDA has undergone formal rulemaking process)

• No later than December 29, 2023, FDA will promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc containing cosmetic products.
• No later than 180 days after the date on which the public comment period on the proposed regulations closes, FDA will issue final regulations.

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) in Cosmetics (Effective date: December 29, 2022)

• FDA will assess the use of PFAS in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use.
  • In conducting this assessment, FDA may, as appropriate, consult with the National Center for Toxicological Research.
• No later than December 29, 2025, FDA will publish a report summarizing the results of this assessment on the Agency’s website.

Animal Testing

• While the MoCRA contains no real requirement on the following issue, it provides that “[i]t is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.”

Enforcement (Effective date: December 29, 2023)

• It is a violation of the FDCA to:
  • Fail to register a facility or submit product listing information as required by the MoCRA.
  • Refuse or fail to follow a recall order or order to cease distribution issued under the MoCRA.
  • Introduce or deliver into interstate commerce any article in violation of the MoCRA requirements regarding facility registration and product listing.
  • Refuse to permit access to or copying of any record as required under the adverse event provisions of the MoCRA.
  • Fail to establish or maintain any record, or make any report, required under the adverse event provisions of the MoCRA or refuse to permit access to or verification or copying of any such required record.
  • Falsify a serious adverse event report submitted to a responsible person or FDA as required by the MoCRA.
• A cosmetic product will be deemed to be adulterated:
  • If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of the MoCRA.
  • If the product, including each ingredient in the product, does not have adequate substantiation for safety as required by the MoCRA.
• A cosmetic product will be deemed to be misbranded if in package form unless it bears a label containing:
  • The name and place of business of the manufacturer, packer, or distributor;
  • An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count (noting that reasonable variations are permitted and there are exemptions as to small packages); and
  • The labeling information required by the MoCRA, as described above.
• Among the other requirements of 21 U.S.C. § 381 (imports and exports), if FDA has credible evidence that a cosmetic product has not complied with the adverse event provisions of the MoCRA, the product will be refused admission into the United States and may be destroyed.

1 “Cosmetic product” means “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” FDCA § 604.

2 The term “facility” includes “any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.” FDCA § 604. The term does not include:

• Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
• Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of the Internal Revenue Code of 1986 (26 U.S.C. § 3508)), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
• Hospitals, physicians’ offices, and health care clinics.
• Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
• Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
• Trade shows and other venues where cosmetic product samples are provided free of charge.
• An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
• An establishment that solely performs one or more of the following with respect to cosmetic products:
  • Labeling
  • Relabeling
  • Packaging
  • Repackaging
  • Holding
  • Distributing

3 “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 [the MoCRA general labeling requirement] . . . or section 4(a) of the Fair Packaging and Labeling Act [(15 U.S.C. § 1453(a)].” FDCA § 604.

4 “Professional” means “an individual who is licensed by an official state authority to practice in the field of cosmetology, nail care, barbering, or esthetics.” FDCA § 609.

5 “Adequate substantiation of safety” means “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.” FDCA § 608.

6 “Safe” means “that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. [FDA will] not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, [FDA] may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.” FDCA § 608.

7 “Adverse event” means “any health-related event associated with the use of a cosmetic product that is adverse.” FDCA § 604.

8 “Serious adverse event” means an adverse event that:

A. Results in:

i. death;

ii. a life-threatening experience;

iii. inpatient hospitalization;

iv. a persistent or significant disability or incapacity;

v. a congenital anomaly or birth defect;

vi. an infection; or

vii. significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or

B. Requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).

FDCA § 604.

9 “Authorized person” means “an officer or employee of the [US] Department of Health and Human Services who has [(1)] appropriate credentials, as determined by the Secretary; and [(2)] been duly designated by the Secretary to have access to the records required under this section.” FDCA § 605.