What is a personal care product? Under the law, some of the products commonly referred to as “personal care products” are cosmetics.¹ Personal care products include a wide range of items such as cosmetics, perfumes, toothpaste and shampoos. A product is considered a drug/pharmaceutical product if it contains an active pharmaceutical ingredient; which is any component contained in a product that is intended to furnish pharmacological activity or other specified therapeutic effect in relation to humans or animals. Personal care products have different regulatory requirements depending upon the product type, while drugs have the most stringent regulations. “Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives.”¹ However, “cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing.”²

How is the general product robustness (safety, efficacy) of personal care products ensured? There are many different robustness assessment components such as preservatives/ antimicrobials content, stability study and a shelf-life evaluation. Preservatives are any substance that, when added to a product, will help prevent microbial growth, contamination, or spoilage. Antimicrobials are substances that are added to products with the intent of destroying or inhibiting microbial growth. These substances are critical in supporting product safety and subsequently help to keep bacteria, yeast and fungi from developing in a variety of consumer goods such as foods, cosmetics, drugs and household products throughout the shelf life of the product. The environment of a well-designed product under normal use conditions will be resistant to microbial intrusion (the extent of resistance being dependent upon the testing parameters). This resistance will allow for the product to be safely used as intended. Products designed with few ingredients, few preservatives, lower level of preservatives or no preservatives still need to be safe for use. The microbial resistant and subsequent robustness of all products can be confirmed through product development such as stability studies and product release testing. Having processes in place alongside current good manufacturing/laboratory testing practices are components in developing a well vetted personal care product that is safe.

Stability Studies

A personal care product shelf life determination is part of the larger guideline for safeguarding product quality and preservative/antimicrobial efficacy known as stability studies (efficacy management). Determining product shelf life is a part of the stability studies, and a control measure that determines how long a product can be on the store shelf and in the hands of consumers. In essence, this testing provides an actual or metaphorical snapshot of a product’s future attributes; an assessment of the product quality that will be maintained throughout its shelf life. Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products.² Stability studies are a regulatory requirement for pharmaceuticals/drugs (over-the-counter) products and includes any products that contain an active ingredient intended to furnish medical and/or therapeutic claims. However, many companies perform these tests on personal care products that do not contain actives. Often this is because these same companies manufacture personal care products that are classified as drugs, and the added diligence in regards to cosmetic product development efficacy may seem prudent.

The stability study process assesses whether a personal care product maintains its intended functionality. The developmental stability process typically encompasses aspects such as the physical, chemical and microbiological efficacy check. During this process, the product is stored under potential use and stress conditions. The longest duration of the product’s stability aging under which testing is performed, must meet the product testing criteria and serves as the maximum allowable product shelf life duration. This testing allows for the evaluation and consideration of product condition in advance. Thus, allowing companies to make any necessary changes prior to distribution to the public, and in the support of high quality product development and manufacturing.

Throughout history, the importance of preservatives/antimicrobials has been emphasized, as these substances have repeatedly proven necessary for the safeguarding of consumers and public health. Guidance and regulatory laws were instituted in response to significant contamination incidents/discoveries throughout history. Subsequently, both pro-active (due diligence) and reactionary milestone events took place:

1820: Eleven delegates/physicians “gathered in the Old Senate Chamber” founding the first US Pharmacopeial Convention in Washington, DC, establishing the US Pharmacopeia (USP), the first compendium of standard drugs for the US.³

1906⁴: The Jungle, by Upton Sinclair, was published based on his investigation of Chicago meatpacking industry conditions. Revealing conditions that were considerably dangerous for workers, as well as exceedingly unsanitary conditions, and the poor quality of the meat (diseased, rancid, contaminated, etc.) distributed to consumers.

1906: “Sen. Weldon Heyburn from Idaho introduced the Pure Food and Drug Act to the Senate in December 1905.” The bill sat for three months; “Senate passed the bill on February 1906.” President Theodore Roosevelt signed the act (S.88) into law on June 30 1906.”⁵

This legislation that would prevent “the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs or medicines, and liquors.”⁶ It’s been published that The Jungle, which “depicted unsafe consumer product distribution,”⁷ and “the harrowing account of the meatpacking industry spurred public outrage that led to legislation.”⁸

1906: Introduction of US legislation signed by President Theodore Roosevelt, which enacted the Meat Inspection Act that empowered the US Department of Agriculture (USDA) to inspect and manage the meat industry.⁹

1936: FDA’s First Chief Educational Officer wrote a book, American Chamber of Horrors, exploring the challenge the government faced in trying to prevent personal care products from causing public health issues.¹⁰

1938: The Federal Food, Drug, and Cosmetic Act is pushed through Congress, and signed by President Franklin D. Roosevelt. The law covered cosmetics, drug labeling, medical devices and pre-market approval of all new drugs.¹¹

Put It to the Test

History demonstrated that the regulatory landscape changed to meet the underlying theme of consumer protection. Personal care product quality is just as important today as it was in 1938. Processes are available that can help the industry in assuring that products released to market are suitable for consumer use. Personal care product development elements such as product testing, manufacturing process management and stability study management allow the industry to assess and subsequently distribute safe personal care products. Thus “the stability study may be seen as a prerequisite for ensuring product quality.”¹²

“The objective of a stability study is to determine the shelf life of a product and to evaluate whether a product in the package is stable when subjected to the market conditions in which it is sold and used.”¹²

However, to simplify, there are two branches of testing to be considered here, analytical and microbiological testing. Analytical testing is performed on the preservative/antimicrobial levels in a product to determine if these are still present and at the expected efficacious level. Microbiological testing, such as the antimicrobial effectiveness test, is performed to determine if a consumer product can withstand microorganisms that may be introduced during use, guarding against microbial contamination throughout the product lifecycle. Another test, the microbial limits test, helps determine if the manufacturing process and environment involved with product formulating and manufacturing is creating a contaminant-free product.

Testing ideally includes product-package compatibility, in which the product is tested in the same packaging that will be used when sold in the market. Using the same packaging during testing allows for a more thorough assessment, and an evaluation of the potential interaction of the formula with the intended package container type.

For Your Consideration

There are three main aspects to consider in regard to the role that preservatives and antimicrobials play within the personal care product industry: safety, health and regulatory and industry guidance. From a safety perspective, these substances are critical in supporting product safety and subsequently help to keep bacteria, yeast and fungi from developing in a variety of consumer goods, foods, cosmetics, drugs and household products throughout a product’s shelf life. From a health perspective, these substances help protect the public from contamination and adulterants in products that would cause harm. From a regulatory and industry guidance perspective, products are expected to be safe, and preservatives and antimicrobials further this end. From a regulatory perspective, “although U.S. regulations do not specify any particular testing regimens for”…certain categories of personal care “cosmetic products or ingredients, it is the cosmetic company’s responsibility to substantiate product and ingredient safety prior to marketing.”¹³

To reiterate, personal care products, with the exception of those that are color additives or regulated as drugs, are not covered by stringent regulatory requirements. However, many companies which distribute personal care products perform the same or similar test on cosmetics as those which are performed on drugs products; for the purpose of demonstrating that cosmetic products will be robust against microbes and also be safe in regards to the products intended use. Thus, aligning with the reasonable expectation for effective and safe product development and manufacturing. For example, by implementing manufacturing line environmental monitoring, manufacturing equipment cleaning and validation, product stability testing, product testing (microbiological, analytical, packaging, etc.), product release testing, etc. There is no substitute for reliable product development testing. Both the product development industry and regulatory agencies recognize that the core and most important aspect of personal care product manufacturing is striving to ensure that all personal care products will perform as intended and be safe for use.

Personal care products still get contaminated; but due to regulatory restrictions, toxicological concerns and consumer trends, fewer preservative/antimicrobial selections are available. Although options are limited, product safety is still a relevant concern. During the past two decades personal care product contamination and recall events have continued; here are some examples:

• FDA Recalls from 2002 to 2016: The FDA recalled 313 cosmetic and personal care products. The majority of these, 76%, were recalled due to bacterial contamination, 237 of 313.¹⁴
• FDA Import Alerts (various countries):14 Executed due to concern for contamination in products such as color cosmetics (eyeshadows, foundations, and mascara), creams, body paints, shampoos, etc.
• Alerts for eyeshadows [2009-2011] containing microbes such as, but not limited to the following: Staphylococcus warneri, Bacillus spp., Bacillus pumilus, Bacillus cereus, and Staphylococcus aureus.
• Alerts for Mascara(s) [2009-2018] containing microbes such as, but not limited to the following: Pseudomonas putida, Bacillus pumilus, Staphylococcus warneri and Bacillus cereus.
• Alerts for shampoo(s) [2009– 2017] containing microbes such as, but not limited to the following: Enterobacter gergoviae, Pseudomonas aeruginosa and Staphylococcus spp. Overview of the number of import alerts “detention without physical examination of cosmetics due to microbiological contamination:” eight alerts (13 sub title products) in 2017 and one alert in 2018.¹⁵
• March 16, 2018: The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials investigated a multistate outbreak of B. cepacia infections linked to a brand of Cleansing Foam.¹⁶
• May 24, 2019: Voluntary recall of styling gel lots, due to contamination with the bacteria B. cepacia, and prompted by microbiological testing resulting in failures, four lots.¹⁷

The root cause of how microorganisms developed within the products cited above were not made public. However, contamination event history and experience demonstrate that microbiological growth found in personal care products can be due to a multitude of risk factors. These factors can range from deficiencies in the formula development processes, such as (i) formula with inadequate or non-existent preservatives/antimicrobials, (ii) raw material contamination, deficiencies in the manufacturing processes (i.e. inadequate batching process conditions), consumer contamination and shipping conditions. Utilizing formula development tools such as stability studies, analytical and microbiological testing can help in addressing many of these potential risk factors. Stability studies and real-time testing aid in the management and identification of most deficiencies in the personal care formula development process and allow for formula and process development adjustments to reduce potential contamination events.

Ingredient Choice

When working with preservatives/antimicrobials it is important to note that the ingredients chosen for inclusion in products fit the intended product application, fit the regulatory categorization of the product, provide a robust defense against microbial growth/contamination (based on directed product use) and allow the product to meet the safety requirements. History demonstrates that regulations and guidance in regards to personal care products have evolved over the years to support the underlying goals of substantiating product safety in the production of quality products. Personal care products, depending on the regulatory category are expected to (i) meet legislation/regulatory requirements and/or (ii) at minimum confirm with the accepted industry standard approach, thus aligning with the due diligence expectations regarding product safety.

Preservative/antimicrobial ingredients are one of the foremost measures for ensuring product safety and are a means for protecting the consumer from contaminates that might be introduced into products during manufacturing or by the consumer themselves during use. But whether the products contain ingredients that afford protection or not, all personal care products can benefit from a stability study assessment, so that the microbial resistance and cleanness of the product can be confirmed prior to distribution to the public. The intent of this assessment is not to be a one size fits all, but instead this assessment is meant to be customized to meet the needs of each product’s unique characteristics. For example, products that do not contain any preservatives/antimicrobials ingredients may require that a product is sold in certain packaging, have a shorten shelf life, or be refrigerated; and subsequently stability testing is customized to address these characteristics. Product development testing and stability studies allow for an optimal assessment of products before distributing to consumers, and the avoidance of potential contamination events. It befits the industry to remain vigilant of both: the importance of product quality, through the performance of stability management/testing; and the importance of product safety through the use of preservative/antimicrobial ingredients. 


References:

1. US Food and Drug Administration (Content current as of: February 1, 2016). Are all “personal care products” regulated as cosmetics? Accessed March (2019), and available at https://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm238796.htm
2. US Food and Drug Administration (Content current as of: July 24, 2018). FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Accessed March (2019), and available at https://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm074162.htm#Who_is_responsible
3. G. Sonnedecker, The Pharmacopeia and America—150 Years of Service. Pharmacy in History, 12, 156- 169 (1970).
4. U. Sinclair, The Jungle. (Jungle Publishing Company, Pasadena California, 1906). First Edition, pp. 108- 117.
5. J. Johnson, Reforming America: A Thematic Encyclopedia and Document Collection of the Progressive Era (ABC-CLIO, Santa Barbara, CA 2017). 1, pp. 113- 114
6. History, Art & Archives, U.S. House of Representatives. The Pure Food and Drug Act. Accessed Nov. (2019), and available at https://history.house.gov/Historical-Highlights/1901-1950/Pure-Food-and-Drug-Act/
7. G. Barak, The Routledge International Handbook of the Crimes of the Powerful. (Routledge, Abingdon, Oxon 2015). First Edition, pp. 51.
8. The New York Times Obituaries. Not Forgotten. (June 2016). Accessed December (2019), and available at https://www.nytimes.com/interactive/projects/cp/obituaries/archives
9. K. L. Rouse, Meat Inspection Act of 1906. Encyclopedia Britannica, Inc. Accessed Nov (2019), and available at https://www.britannica.com/topic/Meat-Inspection-Act
10. R. D. Lamb, American Chamber of Horrors. (New York, Farrar & Rinehart, Incorporated, 1936). Pp. 3- 327
11. US Food and Drug Administration (Content current as of November 27, 2018). Part II: 1938, Food, Drug, Cosmetic Act. Accessed November (2019), and available at https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-ii-1938-food-drug-cosmetic-act
12. International Organization for Standardization, Cosmetics - Guidelines on the stability testing of cosmetic products. ISO/ TR 18811: 2018-02 (E). First edition, pp. v. (2018)
13. US Food and Drug Administration (Content current as of: November 3, 2017). Cosmetics & U.S. Law. Accessed March (2019), and available at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/cosmetics-us-law
14. T. M. Janetos, L. Akintilo, S. Xu, Overview of high-risk Food and Drug Administration recalls for cosmetics and personal care products from 2002 to 2016. Journal of Cosmetic Dermatology, 18, 1361-1365 (2018).
15. US Food and Drug Administration. Import Alert 53-17. Accessed November 2019, and available at https://www.accessdata.fda.gov/cms_ia/importalert_136.html
16. US Food and Drug Administration. (Content current as of May 25, 2018) Outbreak Investigation of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam. Accessed November 2019, and available at https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-b-cepacia-complex-linked-medline-remedy-essentials-no-rinse-cleansing-foam
17. US Food and Drug Administration. (Content current as of May 24, 2019) The Village Company Issues Voluntary Nationwide Recall of La Bella Extreme Sport Styling Gel Due to Bacterial Contamination. Accessed November 2019, and available at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/village-company-issues-voluntary-nationwide-recall-la-bella-extreme-sport-styling-gel-d

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About the Author
Tiffany Jones is a microbiology manager at Lonza Inc. where she works with both hygiene products (disinfectants and sanitizers) and preservation products (lotions and shampoos). She holds a degree from Temple University in Philadelphia, PA. She is an experienced scientist with industry experience from leading companies which has spanned multiple disciplines, such as microbiology, research and development and quality (control, assurance, auditing) in relation to personal care/consumer products, OTCs, pharmaceuticals, new product development and support. She has managed microbiological products/project development on cross-functional teams, regional and global initiatives, which successfully supported the launch of multiple project brands/products.
More info: tiffany.jones@lonza.com; Tel: (201) 316-9360