FDA's Role, Current Programs, etc.
FDA's authority in the cosmetic arena is post-market only, as the law does not provide for FDA pre-market approval. Its responsible for monitoring the safety and proper labeling of cosmetics (cosmetics must be safe when used as labeled or under customary use, and must be properly labeled).
Several speakers at the meeting discussed the current information, programs and tools available; and current safety guidelines, resources, testing, etc., to ensure microbiological safety and/or quality. Currently, FDA's programs and tools for monitoring cosmetic safety include:
- Monitoring of adverse events
- Scientific research
- Inspections of cosmetic manufacturing facilities
- Examination of imported products
- Enforcement action against cosmetics that are adulterated and/or misbranded
- Regulations
- Guidance and other public communication
There was an emphasis on needing to update and restructure FDA's information sources, such as aligning related FDA documents, updating in terms of science and technology, clarifying confusing/ambiguous areas, aligning with international stands, revising the cosmetic GMP guidelines/inspection checklist, revising Chapter 23 of the BAM and more.
Jay M. Ansell, Ph.D., DABT, from the Personal Care Products Council (PCPC) said the industry's current practices assure that cosmetics are safe—via best science and quality management—and proven effective, as adverse events are extremely rare and almost exclusively due to irritation and sensitization, noting the industry is committed to continuous improvement and working with FDA to develop effective, science-based guidance.
Preservatives
David C. Steinberg, FRAPS, executive director for the Cosmetic Preservative Council, which was established in 2006 as a forum and advocate for cosmetic preservative manufacturers and users, addressed the many controversies, misconceptions and issues currently surrounding preservatives.
Preservatives, which serve to prevent retardation of product deterioration from manufacturer to consumer, are handled differently in various countries—the United States only prohibits, doesn't pre-approve; the EU pre-approves via the Annex VI; and Japan pre-approves by type of end-use. Preservatives are used to clean products in order to control contamination by consumers under normal and foreseeable use conditions (adequacy is established via an appropriate preservative efficacy or challenge test [PET]). Steinberg said PET works well for typical products (aqueous solutions), but not atypical cosmetics (low water content, anhydrous or no water as the external phase of an emulsion).
Currently, FDA recommends each batch of a cosmetic that's not self-preserving be tested for microbial contamination during product development and before interstate shipment.
Steinberg pointed out that almost all preservatives have been reviewed, and many have been re-reviewed for safety by the Cosmetic Ingredient Review (CIR), noting many preservatives have been used safely for more than 90 years. The most common safety issue is sensitization usually caused by excess levels in formulations, which most cosmetics companies test for before placing a product on the market. But in the past 30 years, consumers have been exposed to advertising that states what a product is "free of", which can be misleading. Plus, many recalls have occurred as a result of removing certain ingredients, such as alcohol in mouth washes, which is used to preserve the rinse.
"Marketing is quick to claim 'free' of whatever fad comes along without regards to the truth or science," he stated, noting preservatives have become a prime target for this, e.g., parabens, formaldehyde, etc. "This forces formulators to constantly try different combinations and at higher levels to pass PET tests, when their old systems came under attack." The philosophy the preservative industry is fighting against is: if it's natural, it's safe; if it's chemical, it's toxic. So will there be new preservatives developed? No, Steinberg said, due to money, global approvals, etc. "History supports the safety of cosmetics and preservatives," he ended.
Quality
Phil Geis of Geis Microbiological Quality and Advanced Testing Laboratory, discussed the industry's practices in regards to product design (R&D), manufacturing (quality assurance and quality control and consumer safety. He said the United States is the global leader for applied microbiological quality in the cosmetic industry through established and applied best practices, decades of microbiological quality and safety, and cooperation with FDA.
Risk Assessment, Analysis
Arthur Miller, Ph.D., and Richard Whiting, Ph.D., addressed risk analysis, as the foundation to providing structure, transparency and objectivity; and risk assessment, as a tool to evaluating potential hazards.
CFSAN has previously used risk assessments as the basis to inform risk management decision making. Risk analysis is a risk management-centered decision-driven activity, directed toward informed choices and solving problems. It consists of three interacting elements: risk management, risk assessment and risk communication.
- Risk management includes the activities undertaken to identify the problem, become informed of the extent of the problem, and develop approaches to control the hazard.
- Risk assessment measures the risk by providing scientific information on the nature, extent and characteristics of the hazards and risk.
- Risk communication involves the exchange of information and opinions concerning risk and risk-related factors among risk assessors, risk managers, and other interested parties, stakeholders, and the public.
