Fashion – Fashion, Retail and Consumer Branded Products

March 15, 2024 by Duane Morris

How Will The EU’s AI Legislation Influence the Fashion Industry?

Europe’s strides in AI legislation have reached a historic milestone as the European Parliament greenlights the AI Act, setting a global precedent for comprehensive regulation in artificial intelligence development and use. This landmark legislation not only shapes the future of technology within the European Union but also holds significant implications for various sectors, including the fashion industry. […]

Duane Morris partner Agatha Liu emphasizes the need for fashion brands to adopt a customer-centric approach, prioritizing transparency and providing consumers with comprehensive insights into AI-driven processes. The Act’s focus on eradicating bias underscores the importance of inclusive AI models within the fashion industry.

Read the full article on the Vogue Business website.

December 14, 2023 by Kelly A. Bonner

FDA Updates Instructions for Serious Adverse Event Reporting for Cosmetic Products under MoCRA

On December 14, 2023, FDA published updated instructions for reporting serious adverse events for cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enforceable starting December 29, 2023.

FDA recommends that industry “responsible persons” as defined by MoCRA report serious adverse event reports for cosmetic products by using the current MedWatch Form 3500A , which is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (PDF).

FDA has updated the form’s instructions to make it easier for the responsible person to complete the form , and requests that the completed form (along with any information to support the report) be submitted to FDA via email at: CosmeticAERS@fda.hhs.gov or by mail to:

FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993

FDA strongly encourages electronic submission of serious adverse event reports to facilitate efficiency and timeliness of data submission and management for the agency.

FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics, and will provide more information on the launch date for this process in the coming months.

As a reminder, MoCRA requires that a “responsible person” must report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days, and include a copy of the label on or within the retail packaging of such cosmetic product.

If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, the responsible person must submit this new information to FDA within 15 business days.

MoCRA defines the “responsible person” as 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 Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.

Additionally, MoCRA expands the definition of “serious adverse event” ” to include infections or “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.”

Products will not be considered “injurious” if they cause minor or transient reactions to certain users.

This expanded definition still includes previously identified adverse events such as death; a life-threatening experience; in-patient hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; or medical or surgical intervention to prevent any of these outcomes.

September 15, 2023 by Kelly A. Bonner

Introducing Cosmetics Direct – FDA’s New Electronic Portal for Facility Registration and Product Listing of Cosmetic Product Facilities and Products Under MoCRA

Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added Section 607 of the federal Food, Drug and Cosmetic Act (FD&C Act).

Draft screenshots of the electronic system, including example submissions, are available for review and comments, along with an interim Federal Register Notice, announcing the new system.

What’s New

Cosmetics Direct includes the required registration and listing submission information in a standard electronic format to help users organize their registration and listing submissions to include the information needed for FDA. Cosmetics Direct also is intended to give users access to prior Cosmetic Direct registrations and listing submissions.

Cosmetics Direct can be accessed through the Welcome to FDA Direct webpage, which will provide short background information about Cosmetics Direct. New users will need to create an account.

Users who intend to submit information about cosmetics and drugs may create a functional joint account with Cosmetics Direct and CDER Direct, FDA’s portal for drug submissions, which is intended to streamline the submission process.

Notable system features include:

Users will be able to create initial submissions using blank forms, or importing an FDA-accepted SPL stored in a valid XML zip file. SPL (Structured Product Labeling) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. Importing an existing Facility Registration or Cosmetic Product Listing SPL will be beneficial for bulk submission.
By selecting a country outside the U.S. as a facility location, users will be prompted to identify U.S. Agent contact information.
Users will be prompted to sign a confirmation statement, attesting to the veracity of the information submitted, as well as additional contact information for any authorized agents submitting the information.
Users will be promoted to save and validate any new submissions, be able to view the status of registrations and listings, and be notified if system detects any errors through a Validation Failure message. The system will provide a list of errors that require fixing before resubmitting.
Users may also upload and submit existing Facility Registration or Cosmetic Product Listing SPL, and have the option to clone successfully submitted SPLs as starting points.
Users will be able to view the status and details of all submissions on the Cosmetics Direct homepage.

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency; however, those who wish to submit paper forms still have the option to do so via FDA Forms 5066 and 5067.

As of March 2023, FDA discontinued use of Forms FDA 2511, 2512, and 2512a, previously used for voluntary registration activities, and stopped accepting new submissions to the Voluntary Cosmetic Registration Program (VCRP).

Takeaways

FDA’s announcement of Cosmetics Direct comes on the heels of its recent draft guidance for facility registration and product listing, clarifying, among other things, who must register and list, when, and what must be submitted.

FDA has stated that it expects its new portal to begin accepting submissions sometime in October 2023, in advance of the December 29, 2023 statutory deadline for facility registration and product listing.

February 17, 2023February 17, 2023 by Samuel W. Apicelli

Color My World: Aniline Dyes in Fashion

The past centuries have seen a variety of cultural and technological shifts, and the fashion world has followed suit. These changes have also had a profound impact on the way we dress. In the 19th century, the commercialization of newly discovered aniline dyes for printed fabrics had a profound impact on fashion. The use of these synthetic dyes changed the way we colored fabrics, allowing manufacturers to scale up production. Aniline dyes made it easy for manufacturers to print on a wide range of fabric types all with consistent hue and tone of the color between batches. This allowed for the reemergence of the dyeing industry, which was formerly languishing because of its long dependency on expensive naturally derived pigments. Continue reading “Color My World: Aniline Dyes in Fashion”

February 9, 2023February 17, 2023 by Samuel W. Apicelli

From Coal Tar to Couture: The Discovery of Aniline Dyes and The Effect Upon Fashion

Around 1856 an 18-year-old British chemist named William Henry Perkin changed the world of fashion forever. He had been performing experiments seeking to replace the natural anti-malarial drug quinine. Instead of the colorless powder he had expected, he found that oxidizing aniline, a coal tar derivative, produced a reddish powder containing something far more exciting: an intense purple. Fashion would never be the same! This discovery led to the wide commercial availability of low cost, brightly colored fabrics that would be available to all. It also marked the beginning of a hugely profitable business. Continue reading “From Coal Tar to Couture: The Discovery of Aniline Dyes and The Effect Upon Fashion”

January 10, 2022January 10, 2022 by Duane Morris

Blockchain and NFTs Are Smart, but Can They Revolutionise the Fashion Industry?

Following the worldwide disruption in retail due to COVID-19, sales of luxury goods are expected to grow as much as 25% in 2022. Much of this growth has been driven by e-commerce, with online sales totalling 23% of all luxury sales in 2020. Meanwhile, consumer sustainability demands have driven growth in luxury resale or rental markets, now worth an estimated $36 billion, while brands have expanded their reach into the brave new digital territory of the metaverse – the overlapping digital spaces in which we increasingly work, play, and consume.

Yet luxury’s digital embrace has been hampered by a concomitant rise in counterfeit goods in the physical and digital worlds. Is blockchain the solution?

To read the full text of this article co-authored by Duane Morris attorneys Cindy Yang and Kelly Bonner, please visit the Multilaw website.

March 11, 2021March 12, 2021 by Duane Morris

New “.cfd” Domain Extension Tailored to Capture the Virtual Runway

By Michelle Hon Donovan and Anjuli M. Cargain

ShortDot, a domain name registry company, has announced the launch of .cfd (#ClothingFashionDesign), a specialized generic top-level domain (gTLD) for clothing brands, fashion designers, retailers, influencers, bloggers, consumers and lifestyle ecommerce stores. TLDs were developed in the 1980s and have unique purposes (e.g., .com, commercial; .org, nonprofit organizations; .net, network and internet-related organizations; .edu, educational; .gov, government entities). ShortDot’s webpage for registering the new domain states:

By providing a memorable, unique, and relevant web address, .CFD offers clothing, fashion, cosmetics, and footwear brands and designers a unique opportunity to strengthen their web presence.

Trademark owners can register .cfd domain names during the “sunrise period,” which ends April 12, 2021. Continue reading “New “.cfd” Domain Extension Tailored to Capture the Virtual Runway”

December 8, 2020 by Duane Morris

Fashion Companies Targeted by Animal Rights Groups

Michelle C. Pardo, partner and team lead for the Fashion/Retail/Consumer Branded Products Industry Group, is quoted in a Fashion Law article about animal rights groups focusing litigation on certain fashion companies.

From the publication:

People for the Ethical Treatment of Animals is threatening Louis Vuitton with a lawsuit over allegedly “false claims” that the company’s chairman and CEO made in an interview in September. According to a letter addressed to Louis Vuitton chairman and CEO Michael Burke on Monday, legal counsel for the animal rights group “demands” that Burke “immediately end [his] false representations that the animals used for Louis Vuitton products ‘are humanely farmed.’” Such comments amount to “fraud,” PETA Foundation deputy general counsel Jared Goodman asserts, citing a potential “consumer fraud action” against the luxury goods company as a result. […]

“In recent years, animal rights groups have focused their litigation efforts on companies that they perceive are popular with consumers and are delivering messages to consumers about positive animal welfare, environmental stewardship and the production of ethically-sourced products,” according to [Ms. Pardo]. “Animal rights groups view this type of labeling and marketing as a threat to their mission. If consumers feel good about the products that they buy, they are less likely to abandon meat, dairy and other products” – including exotic-skinned luxury handbags – “that are eschewed by many animal rights activists.”

To read the full article, visit the Fashion Law website.

September 28, 2020 by Heidi Lunasin

Diverse Design – Enabling Innovation and Profitability While Creating an Inclusive World

This post was co-authored by Heidi Lunasin and Yalda Hajavi, and it is the first installment of a multipart series.

Around the world, companies are leaving money on the table. Lack of diversity and inclusion in “The Room Where It Happens,” whether the “IT” is a board-room, an innovation team, or a design team, repeatedly has been shown to affect the bottom line. In the realm of innovation alone, experts have estimated that “the size of the economy could be roughly 3 to 4 percent higher if women and underrepresented minorities were included in the innovative process from beginning to end.”[1] This goes beyond merely showing diversity and rather requires inclusion and input at all levels and areas of the innovation process. A further benefit may be that diverse teams encourage design and innovation that is likely more inclusive of a greater portion of the population.

Continue reading “Diverse Design – Enabling Innovation and Profitability While Creating an Inclusive World”