The American Convention Institute (ACI) lately hosted its twelfth Annual Authorized, Regulatory, and Compliance Discussion board on Cosmetics and Private Care Merchandise, bringing collectively authorized consultants, regulatory officers, and business professionals for 2 days of digital and in-person periods centered on the evolving panorama of cosmetics regulation. Hosted in New York Metropolis, the occasion offered updates on state, federal, and worldwide compliance necessities, in addition to sensible insights on threat administration and enforcement traits.
This Q&A highlights key takeaways from three skilled presenters on the discussion board: Dr. Ameki Ooka, Head of International Provide Chain Assets on the Unbiased Magnificence Affiliation, who spoke on the rising influence of prolonged producer duty (EPR) and recyclability rules on packaging selections; Jennifer Santos, Lawyer on the Nationwide Promoting Division of BBB Nationwide Packages, who addressed current updates to the FTC’s Endorsement Guides; and John W.M. Claud, Lawyer at Hyman, Phelps & McNamara, P.C., who mentioned regulatory contrasts in Latin American and Chinese language markets.
Collectively, their insights present a snapshot of the present regulatory pressures and alternatives shaping enterprise selections within the cosmetics and private care product industries.
John W.M. Claud, Lawyer, Hyman, Phelps & McNamara, P.C.
Presentation – Magnificence in Growing World Markets: Contrasting Alternatives and Challenges within the Latin American and Chinese language Cosmetics Markets
CDU: Given your expertise with FDA-regulated entities, what are the commonest compliance challenges that cosmetics manufacturers face when coming into the Latin American market, notably in Brazil and Mexico?
JC: Latin American markets are experiencing sturdy progress, pushed largely by the rise of social media advertising. Nonetheless, the area doesn’t function like a “Southern EU” with a harmonized regulatory framework.
One key problem is that whereas the FDA has largely ceded enforcement of beauty rules to the plaintiff’s bar within the US, nationwide companies like ANVISA in Brazil and COFEPRIS in Mexico take a much more hands-on and rigorous strategy. Consequently, manufacturers accustomed to the comparatively lenient oversight of cosmetics by the FDA should make investments considerably in localized regulatory methods to efficiently enter these increasing markets.
CDU: How do the regulatory approaches of ANVISA in Brazil and COFEPRIS in Mexico differ from FDA oversight within the US, and what key compliance pitfalls ought to firms concentrate on?
JC: In Brazil, ANVISA enforces strict registration and labeling necessities, even for merchandise that may be thought-about “low threat” within the US. Firms should adapt their formulations to adjust to ANVISA’s restricted ingredient lists, security knowledge necessities, and limitations on claims language.
In Mexico, COFEPRIS requires both notification or full registration, relying on the product’s classification. US firms usually face challenges as a consequence of differing definitions, reminiscent of whether or not a product is taken into account a “beauty” or a “therapeutic,” which might considerably influence the regulatory pathway.
Moreover, each international locations require native illustration, that means a authorized entity or accountable third get together have to be current on the bottom. With no educated companion to supply a transparent compliance roadmap, coming into the market can change into a posh and dear course of.
CDU: With rising demand for clear magnificence and sustainability in Latin America, how are regulatory companies adapting ingredient restrictions, and what steps ought to manufacturers take to make sure compliance with evolving rules?
JC: Claims of “clear” cosmetics will be catnip for the plaintiff’s bar right here within the US, until these claims are clearly outlined and substantiated. In Latin America, the danger stems from authorities regulators as an alternative.
That stated, companies within the area are beginning to align extra intently with EU requirements in response to rising client demand for clear and sustainable merchandise. This consists of tighter restrictions on doable endocrine disruptors, preservatives, and allergens, in addition to larger emphasis on biodegradability, security, and toxicological knowledge for brand new or plant-based actives.
Nonetheless, the evolving nature of those rules shouldn’t essentially deter firms from performing. I encourage manufacturers to obviously outline what they imply by “clear” or “sustainable” of their product labeling and promoting and to be ready to help the claims to attenuate regulatory threat.
CDU: What finest practices would you suggest for firms navigating post-market surveillance and regulatory updates in Brazil and Mexico to take care of long-term compliance?
JC: Because of the shut regulatory scrutiny cosmetics obtain within the area, firms ought to deal with post-market surveillance and staying present with regulatory updates as ongoing operational priorities, not one-time duties. Having a certified native liaison is important for implementing product monitoring applications and staying updated with authorized adjustments.
As within the US, sustaining a well-organized central compliance file and conducting common critiques of labels and elements are essential for long-term market viability. Moreover, coaching is commonly neglected—making certain that business and advertising groups are simply as knowledgeable in regards to the regulatory panorama as higher administration could make a major distinction.
The Latin American market is house to a rising center class that locations a excessive worth on magnificence and self-care. A well-designed and executed compliance program is a worthwhile funding for firms looking for to faucet into this doubtlessly high-growth alternative.
Jennifer Santos, Lawyer, Nationwide Promoting Division, BBB Nationwide Packages
Presentation – Influencing Magnificence: Assessing the Influence of the Endorsement Guides on the Cosmetics and Private Care Industries
CDU: What are essentially the most important adjustments within the up to date FTC Endorsement Guides, and the way do they influence cosmetics and private care manufacturers working with influencers?
JS: The FTC’s up to date Endorsement Guides make clear what qualifies as an endorsement and what constitutes a fabric connection between manufacturers and influencers. The FTC additionally took this chance to emphasise the significance of “clear and conspicuous” disclosures, particularly in video and social media content material, whereas offering related examples of each compliant and non-compliant practices.
Beauty and private care manufacturers usually depend on influencer photographs, movies, and tutorials to interact shoppers, so it’s essential that they perceive how to make sure honesty a couple of product’s efficiency and transparency concerning any relationships between manufacturers and influencers in compliance with the brand new Guides.
When manufacturers and influencers clearly disclose connections and make sincere claims, shoppers usually tend to really feel assured of their buying selections, finally strengthening model loyalty and credibility.
CDU: The FTC has set the next commonplace for “clear and conspicuous” disclosures. What are the important thing parts manufacturers ought to concentrate on to make sure compliance, particularly in video and social media content material?
JS: The up to date Guides outline “clear and conspicuous” disclosures as “troublesome to overlook (i.e., simply noticeable) and simply comprehensible by peculiar shoppers” and stress that disclosures must be applicable for each cellular and desktop viewing. The Guides additionally clearly state that when an endorsement is audible, the accompanying disclosure must be audible, and when the endorsement is visible, the disclosure must be visible as nicely.
By way of finest practices, your disclosures usually tend to be thought-about “clear and conspicuous” if they’re each audio and visible. And when crafting that disclosure, make sure to contemplate your viewers. What could also be “clear and conspicuous” for a teen will not be for an aged viewers.
CDU: Latest NAD instances have highlighted shortcomings in materials connection disclosures. What are some widespread errors manufacturers and influencers make, and what finest practices ought to they undertake to keep away from enforcement actions?
JS: Up to now in 2025, BBB Nationwide Packages’ Nationwide Promoting Division (NAD) has printed six selections that analyze and make suggestions concerning a model’s materials connections disclosures.
Listed here are some necessary takeaways from our current instances:
- A fabric connection exists not solely when there’s a monetary relationship between the model and influencer, but in addition when there’s a gifting relationship.
- The influencer, company, and model are all accountable for making certain clear and conspicuous materials connection disclosures are used and utilized appropriately.
- Placement of your materials connection disclosure is necessary. To make sure it’s simply noticeable, it ought to seem above the fold and shouldn’t require the viewer to click on on a hyperlink or to scroll to a different display screen to view it.
- Make certain your materials connection disclosure sufficiently describes the fabric connection. For instance, stating “#paid partnership” alone will not be sufficient with out explaining who the paid partnership is with.
- The FTC acknowledges that utilizing a platform’s disclosure instrument alone will not be sufficient to fulfill the “clear and conspicuous” requirement.
- Contemplate separating your phrases or beginning every phrase with a capital letter in order that the disclosure will be clearly understood by all viewers (i.e., “#PaidParternshipWithBrand” or “#Paid Partnership With Model”)
CDU: With the rising use of AI-generated influencers, what authorized and regulatory issues ought to cosmetics and private care manufacturers have in mind to take care of transparency and compliance?
JS: One of many guiding ideas of the FTC Endorsement Guides is that endorsements ought to mirror the sincere opinions and experiences of the endorser with the product. Beauty and private care manufacturers ought to warning influencers to not use generative AI to create an endorsement that isn’t true or doesn’t mirror the influencer’s precise expertise with the product.
Manufacturers also needs to be cautious in utilizing digital influencers or AI-powered chatbots to answer shoppers’ web site inquiries, as they might present deceptive details about merchandise and even violate FTC tips or sure state legal guidelines.
Dr. Ameki Ooka , Head of International Provide Chain Assets, Unbiased Magnificence Affiliation
Presentation – Packaging In Focus: Navigating the Influence of EPR and Recyclability Rules for the Cosmetics Trade
Dr. Ooka: General, state regulatory our bodies stay very energetic, and in some ways have stepped in the place federal regulation has waned. Prolonged Producer Duty is an space that has not seen a lot federal oversight curiosity (even earlier than this administration) and is an instance of the variability of state-enacted legal guidelines and the ensuing complexity of compliance for firms.
Oregon is the primary state to start reporting, and firms are all watching how this course of works and what charges would possibly end result.
CDU: What’s EPR?
Dr. Ooka: EPR is a coverage framework that requires Producers (normally the model proprietor of a product) to both partially or absolutely fund the gathering, sorting, and waste processing of packaging related to gadgets that they promote and distribute.
Within the US, 5 states have enacted EPR legal guidelines: Colorado, California, Oregon, Maine, and Minnesota. Three states have wants assessments underway—Illinois, Maryland, and Massachusetts. Seven further states have proposed payments thus far in 2025. These embody Connecticut, Hawaii, Nebraska, New Jersey, New York, Tennessee, and Washington.
The primary necessities of EPR legal guidelines are that Producers should:
- Register with a Producer Duty Group (PRO),
- Report the amount and kind of packaging offered and/or distributed within the state, and
- Pay a payment based mostly on the sort and amount of packaging they promote or distribute within the state.
There are some exemptions, usually based mostly on tonnage or income thresholds, however firms have to assessment the legal guidelines in every state, as they’re barely completely different.
CDU: The place are we with respect to the legal guidelines which have been enacted?
Dr. Ooka: Oregon is the primary state requiring reporting submissions, and their deadline simply handed on March 31. Colorado would be the subsequent state requiring reporting, possible by August 31, 2025.
Particular observe on California: CalRecycle simply missed their deadline to finalize guidelines for SB-54, because the governor didn’t log off on the foundations as drafted. They have to revisit rulemaking, however have famous that they won’t transfer statutory deadlines, so this revisit shall be extremely compressed.
CDU: What are the implications for noncompliance?
Dr. Ooka: Every state’s enforcement scheme appears to be like completely different, however typically the state companies could have the fitting to impose financial penalties and different administrative measures relying on the violation.
Penalties vary from $5,000-$50,000 per day, per violation, relying on the state (For instance, Oregon is $25K per day per violation (ORS § 459.995)
Different dangers embody these from class motion or plantiff’s fits, in addition to difficulties in assembly supply discount targets. Many states additionally require that registration lists be made publicly obtainable, which might additionally create points for non-compliant firms.
CAA, the PRO for many state compliance applications, is extra centered on getting firms on the fitting path.
CDU: What are a number of the challenges firms are experiencing as legal guidelines are being applied?
Dr. Ooka: There are some widespread ache factors recognized, notably as Oregon’s deadline loomed and firms needed to collect knowledge. For instance, the definition of a “Producer” is completely different throughout states—that is difficult for companies, as they might be obligated in a single state however not one other.
One other space of confusion is the excellence between Packaging and Product, particularly for cosmetics merchandise. For instance, in Oregon, CAA has famous that the plastic used for an eyeliner pen is taken into account a package deal, however the housing for a writing pen is just not thought-about packaging.
Audio system additionally famous that confusion on the “coated materials” classification of prescription vs. OTC medicine. In some rulemaking, prescription merchandise are thought-about exempt from coated materials classification, however OTC merchandise will not be thought-about exempt.
Thus, in instances the place secondary packaging have to be reported to the PRO, and the place an OTC and a prescription drug product are each delivered to the patron in the identical package deal (for instance, in a cardboard field from an ecommerce pharmacy), it’s unclear whether or not the secondary packaging is taken into account a “coated materials.”
There may be additionally rising concern that non-compliant firms might act as “Free Riders” and never contribute their knowledge and/or charges, leading to law-abiding firms solely bearing the general burden of compliance. On this case, there could also be self-policing throughout the business, as compliant firms or watchdogs might establish suspected “Free Riders” to regulatory or state authorities, or name them out on social media.
CDU: So, what can firms do?
Dr. Ooka: Create an inside Working group and establish course of house owners. Interact Cross-Functionally, and embody Regulatory, Sustainability, Packaging, Gross sales, and Sourcing. Firms also needs to guarantee their high management understands compliance necessities, together with charges, and penalties for non-compliance.
Keep updated with compliance info from commerce associations like IBA.