The U.S. Cosmetic Industry Is Overdue for Change

For decades, the U.S. cosmetic industry has operated in a grey zone – characterised by high consumer demand, rapid innovation, and nearly no regulation. Times have changed! Now, customers want clean, safe, high-performing products that are just as effective. In other words, cosmetics are expected to work like pharmaceuticals.

Yet many brands still manufacture in facilities that don’t follow basic safety standards. Non-GMP manufacturing environments, inconsistent documentation, and low-cost shortcuts have created serious risks. As global cosmetic manufacturers scale at a breakneck speed, the industry is long overdue for change. And now, with the new MoCRA FDA regulations, change is finally here.

The Race to the Lowest Manufacturer Price

Competition in beauty is so intense. Every brand wants the best formulation at the lowest cost possible. But cheap pricing means deeper issues. Many overseas and budget cosmetic manufacturers utilise outdated equipment, do limited testing, have minimal oversight, and lack GMP frameworks.

The pressure to create cosmetics that behave like drugs – anti-aging serums, exfoliating acids, and repair creams – means formulas today use more powerful actives requiring tighter controls. But many brands still place them in non-GMP manufacturing facilities to save money.

The result? Inconsistent and unstable formulations, contamination risks, and product recalls. The savings don’t justify the long-term consequences.

Why Non-GMP Environments Are Dangerous

Unlike pharmaceutical GMP, cosmetic GMP has existed mostly as a voluntary standard. This has led to facilities operating without controls, which are typically required for safe production.

Non-GMP manufacturing environments come with big red flags:

• No standardised procedures for cleaning, sanitisation, and equipment handling
• High risk of microbial contamination, heavy metals, or allergens
• Inconsistent batching and inaccurate ingredient percentages
• Uncontrolled raw material storage and inadequate testing

As cosmetic formulas grow to include clinical-grade ingredients, the absence of GMP becomes even more dangerous. A small deviation can cause major problems.

Upcoming FDA Regulations (MoCRA)

The Modernisation of Cosmetics Regulation Act (better known as MoCRA FDA) is one of the biggest changes in U.S. cosmetic law since 1938. This act brings much-needed structure and accountability to an industry that has operated with minimal regulations for decades.

MoCRA requires:

• Mandatory facility registration for all cosmetic manufacturers
• Product listing and full formulation transparency
• Safety substantiation for every SKU
• Adverse event reporting
• Clear labelling standards
• FDA recall authority

MoCRA brings cosmetic quality standards closer to those of the pharmaceutical industry.

Benefits of GMP Contract Manufacturers

With MoCRA raising the bar, partnering with GMP contract manufacturing facilities is the strongest strategic move you can make.

GMP-compliant cosmetic contract manufacturers offer:

• Strict hygiene, equipment validation, and process control
• Raw material testing and verified suppliers
• Consistent batching and full documentation
• Reduced risk of contamination
• Formula stability, longevity, and accuracy
• Compliance support for MoCRA requirements
• The ability to handle advanced active ingredients safely

In short, GMP ensures your product performs as promised. For brands making potent, results-driven cosmetics, a GMP facility is the baseline.

How Brands Can Prepare

MoCRA is already reshaping the industry. To stay ahead, brands should begin taking proactive steps:

1. Audit your current cosmetic manufacturers to evaluate whether they can meet new GMP regulations.
2. Transition production from non-GMP manufacturing facilities to reliable GMP contract manufacturing partners.
3. Collect and organise ingredient safety data, testing reports, and product files as required under MoCRA.
4. Ensure your product claims align with cosmetic regulations and do not slip into unapproved drug claims.
5. Train internal teams on complaint handling, labelling changes, and compliance expectations.
6. Partner with experienced cosmetic contract manufacturers who understand both cosmetic and OTC-grade standards.

Conclusion

Cosmetics today function more like pharmaceuticals than ever – and with MoCRA raising the bar, the industry must shift from non-GMP manufacturing to fully compliant GMP manufacturing. Working with experienced cosmetic contract manufacturers is now essential for safety, consistency, and regulatory readiness.

Strukmyer Medical, with its GMP-certified formulation, filling, and packaging capabilities, is a reliable partner for brands preparing for MoCRA compliance.

If your brand is ready to upgrade its manufacturing standards, connect with Strukmyer to get started.

FAQ

Will the FDA now regulate cosmetic manufacturing?

Yes. Under MoCRA, the FDA oversees cosmetics manufacturing, requiring safer processes and higher standards from every cosmetic product manufacturer.

What is MoCRA, and how will it affect cosmetics?

MoCRA adds stricter rules for safety, testing, and cosmetics manufacturing to protect consumers.

What should brands look for when choosing a cosmetic manufacturer?

Choose a cosmetic products manufacturer with GMP systems, strong testing, and MoCRA-ready processes – not a low-cost option that risks “MoCRA mafia” compliance issues.

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CITATIONS

FDA (Food & Drug Administration), U.S. Department of Commerce (2022) Modernisation of Cosmetics Regulation Act of 2022

Allure (2021) What All the Scientific Jargon in Beauty Product Claims Actually Mean

FDA (Food & Drug Administration), U.S. Department of Commerce (2024) Cosmetics and U. S. Law