The lines between beauty, wellness, and personal care are blurring. Beauty is no longer defined by appearance. Instead, consumers are looking to build routines that address nutrition, fitness, sleep, and beauty holistically. Hence, the continuous rise of cosmeceuticals and nutricosmetics.

The most widely accepted meaning of cosmeceuticals is “a cosmetic that has or is claimed to have medicinal properties.”¹ It represents a marriage between cosmetics and pharmaceuticals. On the flip side is nutricosmetics. Nutricosmetics are products and ingredients that act as nutritional supplements to help improve skin, nails, and hair.²

The global cosmetics market is expected to grow at a CAGR (compound annual growth rate) of 5.1% over the next seven years.³ However, the nutricosmetics category is expected to grow closer to 6%, and cosmeceuticals are expected to grow at 8.4%, further highlighting which subsegments will drive overall growth within the cosmetics market.^4,5

Established organizations have launched new functional beauty products and cosmeceutical brands to address consumer demand. This has increased scrutiny of efficacy and quality within the cosmetics market. From consumers to international regulatory bodies, everyone is looking for proof.

Cosmetics & Regulations

Cosmetic products are regulated by government agencies throughout the world. These agencies don’t always align on how they define these products or the regulations to govern them. For example, the U.S. Federal Food, Drug and Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness or altering the appearance.”⁶ However, the growing subsegment—cosmeceutical—has no definition under the U.S. Food and Drug Administration (FDA).⁷

The FDA does not require registration for cosmetic products; rather, it is voluntary. Depending on the formulation and product claims, cosmeceuticals could be marketed as a cosmetic or a pharmaceutical. It is important to note that pre-market review and approval by the FDA is not required when a product is marketed as a cosmetic in the U.S. The only exception is color additives, which must be cleared or approved by the FDA for their intended use. Though the FDA does not require pre-market approval for cosmetic products, the agency has the authority to enforce regulatory action by removing adulterated or misbranded products from the market that pose a risk to consumer health and safety.

Navigating regulatory requirements to market cosmetic products in countries throughout the world can be challenging. Not all countries have government agencies that align their regulations with the FDA, and approval to distribute a cosmetic product may require additional registration requirements (with strict compliance to country-specific regulations). For example, to sell within the European Union, cosmetic products must comply with the requirements identified in the EC Regulation 1223/2009.⁸

Common Safety Concerns with Cosmetics: The Ugly

According to the U.S. Voluntary Cosmetic Registration Program (VCRP), some of the most common reasons for cosmetic recalls in 2022 include microbiological contamination and the presence of benzene.⁹

Over a longer horizon, microbial contamination is by far the most reported non-compliance concern when it comes to cosmetics.¹⁰ The root cause of product contamination is often linked to the manufacturer contaminating products throughout the production process and consumers introducing contamination as they handle the product.

Using contaminated cosmetic products can lead to consequential health and safety issues for consumers. Cosmetic organizations have a responsibility to mitigate the risk of contamination by designing safer products for consumer use, as well as to implement a quality management system focused on Good Manufacturing Practices (GMPs).

Ultimately, manufacturers are legally responsible for ensuring the safety and effectiveness of their products. Overlooking safety can lead to a negative impact on customers, employees, and the bottom line. After all, there is no such thing as an inexpensive contamination event.¹¹ As a manufacturer, such an event often leads to the loss of millions of dollars, international recalls, and a detrimental loss of market share.

“A robust testing program covers everything from the testing of raw materials received from suppliers to the testing of finished products to ensure they meet specifications. This testing ensures cosmetic products are manufactured in a consistent manner, yielding the highest quality while also preventing the release of product into distribution that may be contaminated.”

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“A robust testing program covers everything from the testing of raw materials received from suppliers to the testing of finished products to ensure they meet specifications. This testing ensures cosmetic products are manufactured in a consistent manner, yielding the highest quality while also preventing the release of product into distribution that may be contaminated.”

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How to Build an Effective Quality Program for Cosmetics: The Beautiful

Tip #1: Ensure Your Products are Manufactured in a GMP Facility. GMPs are aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use.¹²

GMP facilities implement processes and systems that assure proper monitoring and control of their manufacturing processes. GMP compliance has many benefits. When followed, the system identifies and mitigates risks associated with product safety and quality. Working with reputable raw material suppliers who maintain a clean water system, implement GMP procedures, or work with contract manufacturers with robust GMPs can help prevent product quality issues such as: unintentional contamination, spoilage, loss of traceability, misuse of the final product, or the potential of adulteration.

While there are no regulatory requirements for cosmetics manufacturers to implement GMPs, organizations that do benefit from avoiding costly quality events in the future.

Tip #2: Choosing the Right Preservative. The rise in popularity of and demand for functional beauty products is also driving the rise of the cosmetic preservatives market, which is expected to grow at a CAGR of 8% over the next 6 years.¹³

Preservatives are antimicrobial additives included in product formulations to help maintain the quality of a product. They inhibit microbial contamination over the product’s shelf-life. While there are a lot of preservatives to consider, the move toward clean beauty is driving the need for natural preservatives (or a mix of ingredients that inhibit microbial growth).

To ensure that the preservative you choose for your formulation is effective at limiting microbial growth to the predefined limits, Preservative Efficacy Testing (PET) or antimicrobial effectiveness testing must be performed. Partner with an ISO 17025 accredited third-party laboratory to perform this testing.

Tip #3: Implement and Maintain a Robust Testing Program. Testing of cosmetics does not end with preservative efficacy testing. A robust testing program covers everything from the testing of raw materials received from suppliers to the testing of finished products to ensure they meet specifications. This testing ensures cosmetic products are manufactured in a consistent manner, yielding the highest quality, while also preventing the release of product into distribution that may be contaminated.

Two critical testing programs to implement (alongside PET) that will help detect product contamination include stability testing and ongoing microbiological testing.

Stability testing helps ensure that your product meets physical, chemical, and microbial standards when stored under normal and reasonable conditions. It also helps determine the minimum durability of the product after it has been opened. Alongside PET and a stability testing program, ongoing microbiological testing assures consumers that your products are safe and effective for use.

Cosmetics produced under GMPs also require that every batch is tested for microbiological, physical, and chemical properties. Building and maintaining this level of testing program can often be difficult and expensive for many new and mid-size manufacturers. Consider partnering with an ISO 17025 accredited laboratory and quality consultants (preferably all under one roof) for a quick and cost-effective approach.

Better Quality = Higher Profits

With the rise of online shopping, consumers are hyper focused on quality. In fact, a recent survey by Salsify found that nearly 90% of consumers are willing to pay more for a product when it comes from a brand they trust.¹⁴

Trust is dependent on multiple factors but, according to the Salsify survey, 40% of respondents pointed to product quality as a critical factor in building trust. Retailers also have high quality expectations for cosmetic products sold within their stores. They want cosmetic products that have a good reputation for quality, safety, and efficacy.

Implementing an effective quality program for your cosmetic products can sometimes feel like a burden. Whether it be cost concerns or resource constraints, it can be a daunting process to manage. However, having a dedicated quality team (or partnering with organizations with expertise in quality assurance, compliance, validation, risk management, and product surveillance) can often result in manufacturing a product that consistently meets high quality standards—and reduces the risk of releasing a cosmetic product with consequential safety issues.

Starting with quality as a central tenant to your brand can help drive consumer trust and retention, avoid expensive quality events, and can be the most significant enabler to increased profits.

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A Dirty Secret

Several years ago, I was brought in as a consultant to help address a series of quality events for a small cosmetic company that manufactured a therapeutic cream with hyaluronic acid (HA). With little experience in sourcing raw materials and ingredients from qualified suppliers, the organization made several critical mistakes that resulted in a tarnished reputation to their brand and company, a product recall, and a significant loss of revenue.

The cosmetic company assumed they were purchasing ingredients from trusted suppliers—based on the supplier’s reputation. No due diligence was performed, nor qualification of the supplier through on-site visits, audits, or verification of accreditations and certifications.

With what was assumed to be sufficient quality controls throughout the manufacturing process, the cosmetic company started receiving contamination complaints shortly after launching the new product. Customers reported skin irritation, rash, and hives after using the cream. Laboratory testing of the returned product revealed microbial contamination. Further investigation found that several batches of raw materials and ingredients purchased from suppliers were contaminated, indicating they were likely manufactured in an unsanitary environment where GMPs were not followed.

This experience had catastrophic repercussions for the cosmetic company. Their reputation was damaged, their product was recalled, and consumers lost interest in their products. This type of an event could have been avoided if a supplier qualification process had been implemented and better quality controls had been established to test raw materials and finished products. It is important to keep in mind that there is no such thing as an inexpensive quality event.

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About the Author: Dr. Haven McCall currently serves as the CEO of Canyon Labs. He has spent the last 22 years working in key positions at large, multinational corporations in the areas of clinical research, quality, and regulatory. His doctoral studies at the University of Southern California focused on improving the standard of care for patients through risk mitigation and quality principles. McCall is an active member of the Collaborative Institutional Training Initiative (CITI Program), Society of Clinical Research Associates (SOCRA), Regulatory Affairs Professionals Society (RAPS), American Society for Quality (ASQ), Project Management Institute (PMI), and The Organization for Professionals in Regulatory Affairs (TOPRA – Europe). He has participated within these organizations to drive improvements for industry best practices, regulations, guidance documents, accreditation standards, and European directives. In addition to his CEO role, McCall currently teaches graduate-level courses in clinical research, quality, and regulatory practices at Johns Hopkins University.

References
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