Cosmetic packaging serves more than just product presentation; it also protects product safety and ensures regulatory compliance. However , many brands claim their packaging is "FDA-approved." This claim is false . The FDA does not approve cosmetic packaging ; it only requires that products and packaging comply with FDA standards under the Federal Food, Drug, and Cosmetic Act (FD&C Act) .
The lack of FDA pre-approval for cosmetic packaging doesn't mean companies can freely choose packaging materials .
So how can product compliance be guaranteed? On the one hand, companies must proactively assume responsibility for product safety, while on the other hand, the FDA must take regulatory measures and engage in public oversight.
FDA-Compliant vs. FDA-Approved Packaging Materials
There is often confusion between the terms "FDA approved" and "FDA compliant." Cosmetics companies often use the term "FDA approved" loosely.
The FDA only approves products in categories like drugs, medical devices, and certain food additives. Cosmetics are not among these FDA-approved product categories . However, cosmetic packaging must meet regulatory compliance standards to ensure safety and accuracy.
For cosmetics companies, this means focusing on regulatory compliance —selecting materials and labels that meet FDA safety and labeling requirements—rather than pursuing “approvals” that don’t apply to the industry.
FDA's Role in Cosmetic Packaging
standards play a more limited role in cosmetics than in food and drugs , they still play an important role in protecting consumers.
FD &C Act requires that cosmetics, including their packaging, must not be adulterated or misbranded. While the FDA doesn't test or approve every product before it reaches the shelves, it regulates cosmetics through inspections, product sampling, and consumer reports. If problems are discovered, the FDA can order recalls, seize products, or even initiate legal action.
Additionally, cosmetics companies can participate in the Voluntary Cosmetics Registration Program (VCRP). While optional, it demonstrates a commitment to product transparency and safety .
Key Requirements for FDA-Compliant Cosmetic Packaging
To meet FDA standards, cosmetic packaging must ensure safety, maintain product quality, and present accurate information to consumers.
1. Safety & Non-Toxicity
Packaging materials should not contaminate cosmetics. This is especially true for plastics and printing inks , which can release chemicals into the product if not formulated correctly . FDA-compliant inks and plastics are designed to prevent:
- Migration : Ink chemicals moving into the cosmetic.
- Gas-phase transfer : Volatile substances reacting with air inside packaging.
- Set-off : Ink transferring from one surface to another.
2. Preservation of Product Quality
Packaging must protect cosmetics during transportation, storage and use , ensuring that the product is not damaged by the following.
- Mechanical damage (shocks, crushing)
- Heat and cold
- Bacteria and mold
- Chemical reactions such as oxidation
- UV light damage
- Tampering or opening by unauthorized persons
3. Label Transparency & Accuracy
The label must clearly communicate the product and how it should be used. FDA requires package labels to have the following information :
- Manufacturer or distributor detail
- Net quantity of contentsIngredient list (with specific rules for color additives and fragrances)
- Intended use of the product
Labels must not be misleading. For example, packaging cannot make a product appear larger than it really is
4. Intended Use & Classification
How a product is labeled can change its classification. A cream marketed for “moisturizing” is a cosmetic , but if the same cream is marketed as “treats acne,” it becomes a drug under FDA law.
Common FDA-Compliant Packaging Materials for Cosmetics
Cosmetic packaging typically uses materials that have been recognized as compliant with FDA standards , which provides greater assurance for the product . The specific packaging material chosen depends on the type of cosmetic and the brand's goals.
In addition to the basic threshold of FDA compliance, when choosing cosmetic packaging, you may also need to consider:
- Product characteristics : pH value, oiliness/wateriness, whether the product contains volatile or strong solvent components, etc.
- Barrier properties : Does it need to be protected from light, oxidation, or moisture evaporation? Glass and metal generally provide the best barrier properties, and multi-layer composite plastic technology can also achieve a high barrier effect.
- Sustainable development : recyclable materials (such as PCR), bio-based materials (such as PLA), replenishable design, etc.
- Brand image and user experience : packaging texture, appearance and structural design , etc.
Plastics
- PET (Polyethylene Terephthalate) : Durable and resistant to impact, often used for bottles.
- HDPE (High-Density Polyethylene) : Lightweight, strong, and resistant to mold.
- PP (Polypropylene) : Withstands high heat, suitable for products exposed to sterilization.
- LDPE (Low-Density Polyethylene) : Flexible and squeezable, used for tubes.
Glass
Inert and non-reactive, perfect for serums, oils, and high-end cosmetics.
Aluminum & Metal
- Provides an effective barrier against light and oxygen.
- Recyclable and often used for sprays, ointments, or specialty packaging.
Paperboard & Cartons
Often used for secondary packaging.
Provides branding opportunities while protecting the main container.
FDA-Compliant Printing Inks
Specially formulated to prevent migration and contamination.
Keeps labels safe while maintaining design quality.
FAQ
1. What's the difference between FDA “approved” and “compliant” packaging?
Approved means the FDA has officially signed off (applies to drugs, devices, and food additives).
Compliant means packaging meets FD&C Act requirements (applies to cosmetics).
2. How can printing inks affect FDA compliance for cosmetics?
Non-compliant inks may leach chemicals into the product. FDA-compliant inks avoid migration, gas transfer, and set-off issues.
3.What cosmetic ingredients require special FDA oversight?
Color additives are tightly regulated. Other ingredients are monitored but not pre-approved.
4. Can sustainable or biodegradable materials meet FDA requirements?
Yes, as long as they are proven safe, stable, and non-toxic.
5. How do packaging machines support compliance with FDA standards?
Advanced machines ensure correct filling, sealing, and labeling—all of which are critical for compliance.
Summary
To sum it up, the FDA does not approve cosmetic packaging, but it does require packaging to be compliant with the FD&C Act . Packaging must be safe, protect product quality, and include accurate, transparent labeling.
Common compliant materials include plastics , glass, metals , paperboard, and certified inks . Cosmetic brands should also test their packaging, confirm supplier certifications, and use high-quality machinery to ensure compliance.
At LTPM CHINA , we provide custom cosmetic packaging machinery that helps brands meet FDA compliance requirements. From filling and sealing to labeling, our solutions ensure your products are packaged safely and ready for international markets.
Contact us today to discover how we can support your cosmetic packaging needs.