Since first posting this article, we have found more brands seeking to provide their contract manufacturers with direct access to the Ithos Information Network. This allows the manufacturer to upload documentation directly, saving time while keeping information organized and easy to extract, when needed. Because the IIN only provides access to your brand’s documentation – you can feel safe asking your contract manufacturer to directly upload your documentation.

Asking the right questions up front can avoid costly delays in cosmetic contract manufacturing 

Finding a reliable cosmetic developer and manufacturer is critical in getting a product to market. The COVID pandemic and related supply chain challenges have shown a strong manufacturing partner is key to avoiding costly disruptions. At Ithos, we work closely with brands and their manufacturers to ensure cosmetic compliance throughout the product life cycle. Below, our team of experts compiled five tips for finding the best cosmetics manufacturer.

1. Know the manufacturer’s compliance status (cosmetic vs. drug)

When selecting a cosmetic contract manufacturer, investigate their compliance status with both state and federal agencies. Ensuring they fully comply with the Food and Drug Association’s Good Manufacturing Practices (GMPs) is imperative to the long term quality, safety and marketability of your product. If you plan to sell cosmetics globally, be sure the manufacturer is meeting ISO 22716 standards and can provide relevant  documentation.  If you have a drug product, verify that the manufacturer has a current drug establishment registration in addition to a local state licensure (if applicable) and is in good standing with the corresponding state and federal agencies.

2. Verify experience and competency for your product type 

Manufacturers may promote new production capabilities to attract more business. For example, a cosmetic contract manufacturer may extend their services to include drug manufacturing.  A manufacturer may specialize in liquids or semisolids, but incorporate powder production in their offerings. While it may sound logical and cost-effective, additional processes typically require a significant learning curve in terms of equipment, process and compliance. Scaling up GMP’s from cosmetics to drugs is no small task in development and manufacturing. Be sure to verify specific experience for your type of product up front, to avoid production or compliance challenges down the road.

3. Understand your manufacturer’s capacity 

Every brand has different needs, based on product volume. A small brand may avoid using a large manufacturer initially, because their smaller product run is too costly. Similarly, a larger brand with higher volume needs a manufacturer that can quickly scale up to meet demand. As a smaller brand with lower volume, you represent less revenue for the manufacturer. As a result, you may find once you place an order, you don’t get the attention and support you need for testing, documentation, research & development, sourcing raw materials, etc. At that point, it is too late. Do your homework by asking to speak to current customers of similar size. Be sure the manufacturer has a good track record of client service before you start working together and agree via a contract to their ownership for compliance and R&D related activities.

4. Insist on a formal manufacturing and/or quality assurance agreement

One of the biggest lessons learned during COVID is the importance of formal manufacturer agreements.  While a Quality Assurance agreement is a regulatory requirement for drug products, a contract should also be in place for cosmetic production. To protect your brand, be sure agreements document all  expectations of the manufacturer before you begin working together. They should also detail who is responsible for handling all compliance, operations and financial roles.

A formal outline of all required Product Information File (PIF) documentation should be established, especially when marketing to multiple countries. It speeds up diligence efforts when verifying a brand’s product and facility compliance, and helps meet international registration documentation requirements. Be sure to include the types of development testing required, as well as facility and financial responsibilities. Without agreements in place, a brand can only rely on expectations set for a particular purchase order only – and may suffer unintended and disruptive consequences in payment, production time, ingredient sourcing and other compliance issues. 

5. Gauge your manufacturer’s responsiveness

Vendors come and go, but true partnerships endure – and are key to maintaining your supply chain.  By testing how responsive your contract manufacturer is early in your relationship, you can avoid frustration in the future. Expect accurate, timely responses. If you’re not hearing back quickly, start looking for alternatives. Talk to other customers. Due diligence early on can avoid costly setbacks. Locking in a true partner ensures your contract manufacturer is ready to grow with you, as your product portfolio and target markets expand.

Helpful Links

US FDA Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics

International ISO 22716:2007 Standard

Current Good Manufacturing Practice—Guidance for Human Drug Compounding OutsourcingFacilities Under Section 503B of the FD&C Act Guidance for Industry

Voluntary Cosmetic Registration Program

Drug Establishments Current Registration Site

FDA OTC Registration and Listing

Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry

Whether you’re a brand, manufacturer, retailer, or raw materials supplier, Ithos can help ensure safe, quality, compliant products. We help speed up approvals and alert you to new regulations – all while keeping your documentation and product history organized and accessible. 

Cosmetic Companies Should Be Aware of FDA Regulatory Considerations for Microneedling Products

Despite its growing cosmetic popularity, the Food and Drug Administration’s current micro-needling guidance grants marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. This means cosmetic companies may not be meeting the medical device requirements. Current FDA guidance only pertains to microneedling of the face and abdomen.  Furthermore,  if a microneedling instrument (manual or motorized) does not penetrate the living skin layers (epidermis and dermis) it would not be considered a medical device under current FDA definition. It is important that any cosmetic company considering microneedling accessories consult the full guidance titled, “Regulatory Considerations for Microneedling Products.”

How does microneedling improve the skin’s appearance?  

Historically, micron-sized (extremely small) needles, made of a variety of materials and shapes, have  been used in diagnostics, healthcare, and drug delivery. However, when arranged on a cylinder-like platform and rolled across the face or affixed to the point of a small pen for more precise targeting, microneedles have also become a new tool in exfoliating and improving the skin’s appearance. Because they penetrate the skin, microneedles deliver product directly to a target area, compared to topical application that takes time to soak through skin layers. 

What is the FDA microneedling guidance?

The FDA defines microneedling devices as, “instruments with technological features, such as many small needles, tips, or pins on the surface, which are repeatedly inserted and removed into the skin.” These needles may be rolled across the skin with a small device, stamped on the skin, or arranged on the tip of a pen-shaped instrument. These devices create many small puncture holes in the skin by moving over the skin repeatedly. In addition to its narrow marketing authorization of microneedling, the FDA has only granted marketing authorization for a limited number of medical devices for specific use. By including  potential risks and limits of microneedling on their website the FDA also aims to help consumers better understand microneedling if they are considering using these products.

Will the FDA approve more uses for microneedling? 

Until new, more specific FDA guidance is provided, to ensure consumer safety in cosmetic microneedling, both companies and consumers should do adequate research before using or marketing microneedling products. Further, they should familiarize themselves with the potential risks and side effects of using  devices incorrectly. Pre-existing medical or skin conditions should also be considered. Current FDA microneedling guidance was issued in 2020. 

Fueled by endless video posts on YouTube, TikTok and Instagram, microneedling continues to gain popularity. The procedure, where tiny needles are inserted to rejuvenate skin, can be done at home or by a professional. Beauty brands considering adding microneedling tools or recovery lotions and serums to their product portfolio should be aware of current FDA guidance and limited approvals. 

Ithos continues to monitor microneedling and other emerging cosmetic products, ingredients and procedures. With our continuously updated database of managed regulatory content from over 60 countries, sign up for our newsletter to get the latest updates. 

Increased focus on harmful chemicals, as well as labeling and packaging of bath products and skin care for babies and children 

More states across the US are expected to adopt new regulations on toxic chemicals in children’s products. Laws are already on the books in six states, addressing harmful chemicals in bath and skin care products marketed for baby care and children’s use. They include:

• Minnesota: Toxic Free Kids Act
• Maine: Safer Chemicals in Children’s Products
• New York: Toxic Chemicals in Children’s Products
• Oregon: Toxic-Free Kids Act
• Vermont: Chemical Disclosure for Children’s Products  
• Washington: Children’s Safe Product Act (CSPA)

In some cases, new regulations are proving complicated, with brands relying on the Ithos Information Network to ensure up-to-date cosmetic compliance. In addition to limits on chemicals of concern (CoC), some states are also now requiring new government reporting of ingredients for both importers and domestic manufacturers.  

With a growing number of brands promising “clean” products for babies and children, more attention is focused on the safety and sustainability of baby products and children’s skin care products, including safe makeup for kids. In addition to chemicals of concern, many new regulations also address:

• Labeling & product warnings
• Directions for use
• Child-resistant packaging
• Raw materials 
• Impurities

In the European Union, more attention has been given to safety risks of cosmetic and personal care products that resemble food – including those marketed to children. From “cupcake” bath bombs to “smoothie” shower gels, these types of product issues and recalls are posted weekly in the European Union, via a list called Safety Gate. It covers all consumer products in the EU (except food), and lists product names. Cosmetics are included in Safety Gate. Updates are also expected to Safe Products for Children, a formulation guide created in 2012 by the the Council of Europe Committee of Experts on Cosmetic Products (P-SC-COS).  

Whether you are trying to stay ahead of new state regulations or adding a new children’s product to your portfolio, Ithos can save valuable time and money. Our IIN platform provides instant, compliant ingredient reporting to ensure product safety, and our team of regulatory experts can help troubleshoot compliance challenges. Contact us to learn more. 

The Golden State added several new laws affecting cosm In addition to the legislation outlined below, California has made two more major changes, affecting most cosmetic and personal care brands: 

Signed into law on June 30, 2022, SB 54 requires all packaging to be recyclable or compostable by 2032. It goes further than any other state legislation in addressing plastic production and recycling. 

The Golden State has extended reporting, via SB 484 for intentionally added ingredients, to those ingredients present in fragrances and flavors used in cosmetics. California’s “Reportable Ingredient List” (SB 312) has been revised to include references to INCI names and the International Fragrance Association (IFRA) ingredient list. Check out our story about the “Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 or SB 312 for a helpful FAQ, which includes a full list of reportable ingredients and allergens.

Many brands are using The Ithos Information Network software solution to screen formulas against the new updated ingredient list to identify products that must now be reported in California. 

CA SB 343 – Environmental Advertising: Recycling Symbol

Passed in 2021, CA SB 343 seeks to end consumer confusion by clearly defining the recycling symbols on product packaging, while prohibiting any false or misleading recycling claims. “Environmental Advertising: Recycling Symbol,” forbids the word  “recyclable” on any product packaging that is not 100% recyclable to prevent cross contamination with other recyclable materials. Further, the bill restricts use of recycling symbols on packaging where there is insufficient packaging documentation. This includes preventing the Plastic Resin Identification Coding System from being labeled on packaging that is not recyclable in the state.

CA AB 45 – Industrial Hemp Products  

Adopted last year, AB 45 now imposes new legal regulations on food, drugs, devices and cosmetic products containing industrial hemp, cannabinoids, extract, or derivatives from industrial hemp.  However, it includes the provision that prohibits restrictions on the sale of cosmetics with hemp, solely because they include hemp, cannabinoids, extracts or derivatives from industrial hemp. The goal of the law is to prevent misleading labeling about health-related benefits from consuming products containing hemp, cannabinoids, extract or derivatives from industrial hemp. 

Notably, the law also requires a Certificate of Analysis for all cosmetics containing industrial hemp that demonstrates a safe THC level (below 0.3%) as well as a safe origin of the hemp ingredient. 

Additional requirements include:

• Adequate testing and labeling for specified products, including hemp, through an authorization process. 
• A $250 fee for all manufacturers of industrial hemp, to fund the Industrial Hemp Research Program at the University of California.  

CA AB 818: Solid Waste: Premoistened Nonwoven Disposable Wipes

To address the environmental impact of disposable wipes, CA AB 818 targets all nonwoven, disposable wipes including bathroom, makeup removal, diaper, feminine, and cleaning and sanitizing wipes. It includes the “Do not flush” labeling requirement on any pre moistened, nonwoven disposable wipes. The law also prohibits symbols or images indicating any flushable attributes of the disposable wipes. 

Notably, the law now requires all manufacturers of pre moistened, nonwoven disposable wipes to participate in a collection study with wastewater agencies until 2027. Done in collaboration with an educational program, it will require manufacturers to take on additional responsibilities that foster more consumer awareness about the need to recycle wipe products. 

As always, if you have questions about how these measures may affect your current – or future– products, our Ithos team of regulatory experts is ready to help. Cosmetic brands of all sizes rely on our compliance experience and insights to navigate new regulations.