Today the U.S. Food and Drug Administration (FDA) announced the launch of its Cosmetics Direct electronic submission portal for registration and listing of cosmetic product facilities and products, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The Cosmetics Direct portal, now available for industry, is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. Cosmetics Direct is accessed at https://direct.fda.gov/. 

Cosmetics Direct is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, with user-friendly data entry forms that creates, validates, saves, submits, processes, and automatically transmits the SPL submission to FDA for internal processing without having to use the Electronic Submissions Gateway (ESG).  

FDA is also accepting cosmetic product facility registration and cosmetic product listing submissions via SPL-formatted submissions through the ESG. In addition, FDA is also developing SPL-X forms that is anticipated to be available soon. 

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

FDA is also developing paper forms for cosmetic product registration and cosmetic product listing as an alternative submission tool that are anticipated to be available soon.

Delayed Enforcement 

On November 8, 2023, FDA issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

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.

Today (Nov. 8, 2023) the U.S. Food and Drug Administration (FDA) announced it will delay the enforcement of the requirements for cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for an additional six months after the Dec. 29, 2023, deadline (i.e., July 1, 2024) to ensure the industry has sufficient time to submit such information.

In addition, the 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 Dec. 29, 2022, or the listing requirement for cosmetic products first marketed after Dec. 29, 2022, until the July 1, 2024 deadline. 

Read more: 

https://www.cosmeticsandtoiletries.com/regulations/safety/news/22878741/fda-delays-mocra-enforcement-by-6-months?utm_source=newsletter-html&utm_medium=email&utm_campaign=CT+E-Newsletter+11-08-2023 

Debut, a synthetic biology company, has partnered with DIC Corporation to biomanufacture and sell many rare and natural polyphenol ingredients for the beauty industry. The partnership will deliver novel, high-performing, and clinically backed polyphenols that are too expensive or environmentally unsustainable for consumer products. The multiyear agreement focuses on bringing rare naturals made possible through Debut's Bio2Consumer™ platform. This partnership aims to win on cost and performance relative to established cosmetic ingredients, targeting the personal care market valued at $416B, with a 5% CAGR. Debut's platform combines cell-free enzyme catalysis and precision fermentation to eliminate the bottlenecks currently associated with synthetic biology, requiring far less land, water, and energy than traditional manufacturing.

The partnership will see Debut build a commercial biomanufacturing site owned and operated by the company, with construction beginning in the coming months. DIC, whose customers include brand owners that prioritize safety, efficacy, and sustainability, will lead ingredient sales, marketing, and distribution of these ingredients globally. The biomanufacturing site will allow the company to deliver new cosmetic ingredients with revolutionary capabilities to the beauty industry, realizing its goals.

DIC, a fine chemical company with a top global market share for printing inks, organic pigments, and other compounds, is committed to creating new businesses that respond to environmental, social, and health-related issues and social changes. DIC's Managing Executive Officer, Kiyofumi Takano, said, “Debut's vertically integrated synthetic biology platform technology and commitment to transition from discovery to scaled-up biomanufacturing, combined with clinical testing and formulation is a huge leap for biomanufacturing and will allow us to start seeing synthetic biology derived products on shelves in the global marketplace. They are the only company that goes from novel ingredient discovery to commercial manufacturing, clinical testing, and formulation - that's the future.”

Debut’s CEO, Dr. Britton, said, “DIC understands the complexities and demands of the beauty industry. We’re excited to move forward with them to grow and advance new sustainable and high-performance ingredients. Brands need access to new and rare natural ingredients that allow them to win in the marketplace based on their performance and not just a marketing story. Synthetic biology allows access to incredible products found only in trace quantities in nature. To date, consumers have been using traditional active ingredients when better-performing ingredients are available in nature - we just had to work out how to make them for consumers.”

Debut and DIC's partnership aims to create a sustainable future for the beauty industry by offering rare and natural cosmetic ingredients concurrent with constructing a commercial biomanufacturing facility slated to come online in 2024. This facility will allow the companies to provide access to sustainable, natural ingredients that cannot be obtained through traditional cultivation or chemical production, setting a new standard for a profitable business to face an ever-changing world.

Versed Skincare, the clean, cruelty-free, and vegan skin products beauty company, is expanding its reach to offer high-performance, clean skincare to a broader audience through its partnership with Walmart. Since its launch in 2019, Versed has become the fastest-growing mass brand in clean skincare, with a community of dedicated consumers who appreciate its effective, affordable, and straightforward products. The brand's mission to create skincare that benefits the skin, body, and planet has resonated with many. With its rollout in Walmart, it aims to make clean beauty accessible to more people.

Melanie Bender, President of Versed, expressed excitement about bringing their results-driven skincare to Walmart customers. For many of their consumers, Versed is the first clean skincare brand they have tried, and the brand aims to break down barriers in the clean beauty industry. Versed's approach is community-driven, leveraging six proprietary data types to develop formulas and choose retailers that align with their values. The brand's consumer-centric values include formulating per the European Union's safety standards, and going above and beyond to avoid using questionable chemicals, silicones, added fragrances, added colors, or animal-derived ingredients.

Versed's commitment to sustainability is also an essential aspect of its mission, with initiatives such as achieving Climate Neutral Certification and net-zero greenhouse gas emissions since launch, using 50% post-consumer recycled content in packaging, and leading over 250 brand partners in climate action through CodeRed4Climate. The brand is certified by Leaping Bunny as an animal cruelty-free brand.

Versed's hero products, including the Dew Point Moisturizing Gel-Cream and Press Restart Gentle Retinol Serum, have been tested and approved by a community of 80,000 digital co-creators and are loved by leading skinfluencers. Walmart Beauty Senior Merchandising Director Paula Ryan said that Versed is a brand customers are excited about, and Walmart is thrilled to add it to its growing assortment of skincare products.

Starting February 1st, 2022, Versed's lineup of high-performance treatments, cleansers, and moisturizers, all under $25, will be available on Walmart.com. From February 26th, 2022, the products will be available in over 3,000 Walmart stores.

With its commitment to democratization, sustainability, and consumer-centric values, Versed is poised to become a go-to brand for digitally-native consumers, with over 75% of its users being millennials or younger.

A statement from Lezlee Westine, President & CEO, Personal Care Products Council

The Personal Care Products Council (PCPC) is dedicated to collaborating with the U.S. Food and Drug Administration (FDA) to safeguard consumer health and comprehend the potential impact of the FDA's proposed reorganization on the regulation of cosmetics and personal care products. The PCPC remains committed to supporting the Agency and other stakeholders to ensure that any reorganization will allow the beauty and personal care industry to provide innovative, safe, and effective products while maintaining consumer trust, as we have done in the past.

Our immediate focus is working closely with the FDA to effectively execute the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. This groundbreaking legislation provides the FDA with additional tools to ensure cosmetics safety and protect public health, thereby strengthening consumer confidence in the products they rely on daily. MoCRA also aligns the FDA's oversight of the beauty and personal care sector with other categories the Agency regulates, contributing to global regulatory coherence. We welcome the leadership of Dr. Namandjé Bumpus, the FDA's Chief Scientist, who will oversee MoCRA's implementation since cosmetics and personal care products will now be handled by the Office of the Chief Scientist within the Office of the Commissioner. We believe that the Commissioner's decision is the right one.

As the FDA moves forward with the proposed reorganization, our industry is committed to working with the Agency and providing our expertise to promote appropriate regulation of cosmetics and personal care products. We acknowledge the significance of transparency in regulatory decision-making and will continue to advocate for a transparent, science-based, and risk-based approach to regulation.

For more information on cosmetics and personal care products and their ingredients, please visit www.CosmeticsInfo.org.

Los Angeles, CA – Beauty Industry West (BIW) is pleased to announce the election of the organization’s Executive Board, which will serve 2022-2023. The Executive Board is a volunteer position and is the governing body that oversees the strategy, mission and of the association and is responsible for representing the interests of its membership. 

Effective immediately, BIW’s Executive Officers are:

President

Dustin Cash

SOS Beauty Group

West Hollywood, CA

Vice President 

Florence Nacino

KDC/ONE SOCAL Labs

Walnut, CA

Secretary

Amalia Gonzalez

Minerva Research Labs

Los Angeles, CA

Treasurer

Joanne Lee

Kaplan MD Skincare 

Beverly Hills, CA

Assistant Treasurer

Lisa Martines

Baralan USA

Los Angeles, CA

Executive Advisor

Ken Collins

AdCraft Labels

Anaheim, CA

The other voting members of the Board of Directors are Candace Krose (Necessaire), Eric Light (Aroma Naturals), Erin Breve (Barnette), Francesca Oasis (Kerstin Florian Intl.), Guy Langer (Qumulus Group), Holly Ohriner (Skinn+), Jerry Whitmore (Juniper Labs), Lynn Ludlam (Esche & Alexander), Margarita Gomez-Nadin (Deveraux Specialties), Oralia De Anda (Best Formulations), Roni Schmelz (Tucker Ellis), Thammasat Tantipinichwong (Brenntag Specialties), Yi Hsin Chang (Global Ingredient Solutions).

“It is an honor to be elected to lead this organization and serve our membership,” said Dustin Cash, newly-elected President of BIW and CEO of SOS Beauty Group. “I look forward to working alongside our new board to develop and expand upon our member benefits and better serve our greater community of beauty industry professionals.”

Under Cash’s stewardship, BIW members will look forward to expanded community and networking opportunities, education, events, industry resources and philanthropic initiatives. These new programs will include founder mentorship, digital education, industry innovation awards, career development resources and more. 

BIW will host its first annual Awards Gala on Tuesday, November 8, 2022, honoring BIW’s  “Entrepreneur of the Year”, Tiffany Masterson (Founder and Chief Creative Officer of Drunk Elephant) as well as BIW’s “Innovator of the Year”, Susan Goldsberry (Founder and President of Benchmark Labs). For more information, please visit beautyindustrywest.org/events 

About BIW

Beauty Industry West (BIW) is a non-profit organization that was established in 1990 by a group of West Coast based industry leaders, including Robert & Suzanne Grayson and Lynn Ludlam. BIW is the premier West Coast trade organization focused on bringing together today's innovators, entrepreneurs, experts and future industry leaders. We bring together the best of beauty to learn, network, collaborate while having fun! To learn more and to join, visit beautyindustrywest.org.

It is important, but sadly infrequent, that true inclusiveness exists in the beauty industry. Going back in time we often noticed the limited range of foundation shades and much needed specialized hair care products for Black women. Given the current social climate, it's imperative to recognize this fact and work to change it. I think we are beginning to make progress in the right direction.

There are many incredible Black women who have already changed the beauty industry for the better, from makeup artists to entrepreneurs to scientists. Here are a few to remind us of their important contributions over the years.

Madam C.J. Walker

One of the first women, Madam C.J. Walker (born Sarah Breedlove) invented a line of haircare products in 1905 after suffering from hair loss. It was so successful that she became the first African American woman to become a self-made millionaire.

In addition to her inspiring financial success, she helped usher in a movement of speaking directly to her customer through self-promotion, door-to-door sales, and product demonstrations. Her method was a huge change from the current brands at that time, which were primarily owned by white men and advocated hair straightening products that were not helpful to black hair or hair loss.

Lisa Price

Price founded beauty brand Carol's Daughter in her Brooklyn kitchen in 1993. As time went on, the brand gained international loyalty and eventually becoming one of the most recognizable natural-haircare brands on the market.

Carol's Daughter is one of the first African American woman–owned beauty brands to have a flagship store and premier shelf space in department stores. She set the ball moving for many African American woman–owned companies to come.

Pat McGrath

Pat McGrath is more than just a legendary makeup artist. Her stunning artistry has transformed the industry, taking over runway shows, the streets at Paris Fashion Week and now the shelves at Sephora with her eponymous line, Pat McGrath Labs.

Her inventive creations are now trends. She's not only the most requested and prolific makeup artist but also the most influential (see terms like “incandescent skin” and “strobing”). She has had a major impact on both the prestige and mass beauty markets. If you ever thought about wearing glitter or shimmer, check out her unique line.

Alicia Keys

Celebrity singer Alicia Keys has been at the forefront of a “makeup-free” movement, forgoing foundation, and eyeliner for healthy, hydrated skin. While she clarifies she's not anti-makeup, it's inspiring to see a woman show off her bare face and stand up for natural beauty.

Her act of defiance and devotion to the cause, allows women to feel comfortable in their own skin. This sets a precedent. She uses her platform to give young women something else to look up to, appearing on magazine covers sans makeup and thus spearheading a message of honesty in the beauty industry.

Balanda Atis

Atis, now L'Oréal's Women of Color Lab Manager, was working in research and development for the company but always had trouble finding shades to match her skin tone. She took on a side project to develop new shades in the lab, eventually spearheading a new category devoted to creating a wide spectrum of shades for Black women in all L'Oréal products.

Foundation shades are incredibly personal and, for women of color, can be especially difficult. Atis realized the struggle firsthand and used her position to make a difference in the industry, creating a diversity standard for all L'Oréal products moving forward.

It is incredible how a strong desire and dedicated determination can push people to achieve great success and make an impact in this world. If we continue this trend of listening to new ideas and gaining inspiration from women of color, we will become one of the most inclusive industries and lead the way for others as well.

Lisa Martines - Board Member

 

“Beauty and the Bottle”

A perfume without its bottle is just a mixture of substances, a cream without its jar remains only a semi-solid mass, and the same goes for most make-up formulations. However, with packaging each of these products has its own wardrobe that completely enhances it. Taking it from nothing into something beautiful, functional, unique & special. A form that contains beauty not just for the function, but to completely enhance its true essence and bring alive it’s spirit!

To be able to transfer the essence of perfumes, creams, make up, and everything we use daily, into visually captivating containers that fill our homes (and handbags) is a specialty that brands rely on from the industry experts. Leaders in the primary packaging world want to create and offer packaging that people can be proud of using.

Some primary packaging companies create, design, engineer, manufacture and customize their own containers, along with related accessories, to offer exactly what the end user needs and to provide the highest quality components. There are many things to consider when selecting your final components. Bottle height, size, shape and color. Neck size (there are many) with a crimp top or screw top. What type of dispenser are you looking for? Screw top, dropper, serum pump, spray pump or roller ball? Do you want your bottle decorated? Some packaging companies will also provide this important next step. Beautiful bottle decoration will completely accentuate the brand identity. Your choices are endless when selecting your individual and unique style.

For experienced primary packaging companies, there is a daily challenge to present a wide range of high-quality products largely available in stock and in various locations globally that meet the increasingly personalized requests of the beauty industry, with the aim of being recognized as a leader of excellence in the Beauty Industry.

Imagine that each one of us would like to see ourselves always beautiful and at the same time always different or unique. It is important to combine constant innovation with the values and history of the past. In each new bottle or jar developed, there is a story to be told just like each one of us.

A jar or bottle apparently simple in shape can always be made to look stunning with the right innovative accessories and especially a unique design concept. Bottle decoration includes various techniques such as: molding, acid-etching, varnishing, screen printing, hot stamping, pad printing along with the use of vitrified enamels and precious metals such as gold or platinum. The bottle spray color can include transparent, opaque, glossy, gradient or matte finishes along with silkscreen which can combine a wide range of colors and designs on each bottle. All of this is usually done with a quality control system in place and approvals throughout the production pipeline, which guarantees precision on the bottles.

The components whose functionality, durability, and stability are always well studied will be the most successful in the market. Bottle and accessory shapes should strive for an elegant style and an aesthetic harmony while allowing the personalization of each product. This ensures that it always transforms into something truly unique and appealing. Good packaging captures the essence of beauty as it frames the product and the brand concept, making it indelible. Packaging companies operate in a world market that increasingly looks toward innovation and eco-friendly solutions, which will make everything more beautiful in the long run.

Lisa Martines works for Baralan Group, a global primary packaging company who prides itself within the beauty industry as a historic Italian company who has an open, flexible and dynamic vision, with an international presence and a widespread distribution of products in more than 50 countries. The Baralan Group brings “Made in Italy” to the world, which is understood as a symbol of beauty, design and impeccable taste combined with an excellent level of quality and service. Always appreciated worldwide and recognized as industry leaders.

LIsa Martines - West Coast Key Account Manager

Lisa.Martines@Baralanusa.com

Mobile 310-365-0419

Challenges of Global Regulatory Mandates

If your brand’s goals include entering more than one global market and are interested in doing it correctly, you are in for a series of challenges to overcome.

Here are several things to consider:

• Variations in ingredient nomenclature - INCI (International Nomenclature of Cosmetic Ingredients): It sounds like a great idea to standardize the way cosmetic ingredients are listed all over the globe, but it isn’t as simple when it comes to the way it really works. EU wants allergens listed, Canada doesn’t like “Water (Aqua)”, prefers “Water”. Some botanicals include their common names, others don’t. This still goes back and forth every so often.
• Globally-accepted ingredients with various level of use restrictions and applications (rinse-off products vs leave-on for example). Depending on the how a formula is categorized and its function, allowable ingredient levels vary amongst different markets. Ingredient categories that seem to trigger include AHAs, surfactants and preservatives. Additionally, the Hot List (prohibited ingredients) between US, Canada and the EU shows a huge disparity, further complicating and limiting the creation of globally-accepted formulas.
• Disparity of cosmetic marketing phrases are extremely varied, such as: you cannot say “free of” anything in EU, Canada doesn’t like the word “blemish”. These are just a couple of examples of what you can or cannot say.
• Marketing (Social Media) – how do you create a uniform message that complies globally? A brand’s story can get diluted very quickly when it must create different stories for fit each market’s specific set of rules. But you really must investigate each market guideline carefully.
• Intellectual property – global protection is not possible so enter with caution. In order to secure intellectual property for “BRAND X”, one must do it for each country or region separately. This comes at a potentially very high expense, not to mention that if the mark is taken by only one country, the owner must either abandon that market, use a different name in that market, or move forward without a mark and risk having the mark owner take action against him/her.
• All this leads to the need for market-specific packaging.

Having country-specific packaging and/or formulas would be ideal, but how practical is this really? Ideally, there would be a uniform set of regulations and laws globally and covering all aspects of our industry - made clear, simple, and reasonable to execute. It’s a stretch and it may be viewed as a naive wish, but the current way is not the most desired path. The easiest way to go about it is to choose a single market or a region with similar rules and grow the brand there before considering a wider expansion.

By Toni Abbruzzese

AAL - Hand Sanitizer Analysis & COVID-19 Swab Testing

We are currently facing a challenging time in which the "Coronavirus" is the dominating topic. We are aware of the increased demands for the manufacturing of health protection products and have great respect for the task of ensuring the continuing supply of these products. Adamson Analytical offers the analysis necessary to move forward with production and some of these analyses can be completed within the same day. With the increased demand for Hand Sanitizers, we have put together the following Information on Time Kill studies which are necessary for proving the efficacy of the product.

Due to the increasing need to ensure the safety of everyone during this time, Adamson Analytical Laboratories has expanded our capabilities to Include COVID-19 Surface Swab Testing. More Information on these analyses is listed below. Feel free to also reach out to Jackie Sirois at jackie.sirois@tentamus.com for any additional questions.

Information on "Time-Kill Test"

Products with antimicrobial properties like disinfectants and sanitizers should be tested for their antimicrobial activities. The ASTM standard method E2315-16 is used to assess the in vitro reduction of a microbial population of test organisms after exposure to a test material. In this test the main parameters that should be varied are the selected microbiological organisms which should be killed, and the exposure time of the product to the microorganisms. The actual number of colonies of living microorganisms remaining after the exposure are then plated on an appropriate agar and then counted after the prescribed incubation period.

It is also strongly recommended that the time kill study is paired with a Minimum Bactericidal Concentration (MBC) or Minimum Inhibitory Concentration (MIC) study as well. These studies help to assess the lowest concentration of an antimicrobial product to kill or inhibit the growth of a specified organism respectively.

The following organisms can be used as representative markers for assessing antimicrobial properties and is recommended for ingredients already classified as GRAS/GRAE (Generally recognized as safe and effective):

Please note that additional organisms can be ordered and included in the study upon request.

COVID-19 Surface Swab Test

Beginning Wednesday April 8, 2020, we are offering surface swab testing of critical objects for the Coronavirus (SARS-CoV-2).

We provide you with suitable swabs, which you can then use to swab the surfaces of objects including but not limited to:

·       Products (Food, Supplies, etc.)

·       Mobile phones

·       Door handles

·       Light Switches

·       Handrails

·       Keyboards

·       Shopping carts

·       And many more

These samples will be analyzed in our laboratories by RT-PCR.

With the order, you will receive a COMPLETE swabbing kit that includes everything you need to get started. Just swab your critical areas according to the instructions and seal the vial. We take care of the rest!

Some more specific questions based on frequently asked question will be discussed following.

The analysis is performed using the protocol (“Real-time RT-PCR assays for the detection of SARS-CoV-2”) listed by the WHO.

The result of the detection of coronavirus SARS-CoV-2 / swab (recommended area of 25cm² or 2 in. x 2 in.) RT-PCR Result are expressed as: positive/negative. In the case of positive detection, the test report includes a statement that RNA from coronavirus SARS-CoV-2 has been detected.

The limit of detection of the test system shows 5 -7 RNA copies/µl In tests on surfaces, positive results have been demonstrated with swabs on approx. 10,000 bacteriophages/25cm². (for safety reasons bacteriophages are used as test organisms in the laboratory). This is realistically achievable in a coughing outbreak of an infected person.

No uncertainty of measurement can be determined for qualitative results. Nevertheless, the specificity for the tested microorganisms is 100% - so there are no other viruses that gives the same result.

Please feel free to contact us with any questions or requests for quotations - we are happy to support your business!

Adamson Analytical Laboratories Inc.
220 Crouse Drive, Corona, CA 92879
Office: (951) 549-9657