Cosmetic products labeled as "natural" or preservative-free are top priorities in FDA's oversight work due to concerns about microbial contamination, based on an updated guide for internal use by agency personnel.

According to FDA, its "Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA."

The updated resource at issue, "Cosmetics Compliance Program: Import and Domestic," recently posted to the "What's New In Cosmetics" page of FDA's website, providing insight into areas of increasing focus for the agency.

FDA notes in the document the rapid technological changes occurring in the cosmetics sector, as well as another development – "consumer distaste for traditional preservatives."

The agency points out that parabens, "one of the most effective classes of preservatives," are being phased out in the European Union in particular due to their suspected endocrine-disrupting potential.

Consequently, manufacturers are turning to "non-traditional preservative systems" to ensure the microbial safety of their products, it says.

"FDA is concerned that cosmetic products that make a statement in labeling that the product is 'green,' 'natural,' 'no parabens' and 'no preservatives' may not be safe for consumers without appropriate safety testing. Companies and products that make such label statements should be given priority over traditionally manufactured cosmetics during inspection and sampling," according to the manual.

The agency says non-traditional preservative systems being employed are typically botanical extracts, organic acids, alcohols or glycerols, as well as fermentation products, and provides a "small sample" list for reference by its officials in their regulatory activities.

According to FDA, non-traditional preservatives include:

Glyceryl caprylate
Levulinic acid
p-anisic acid
Eucalyptus globulus
Glycyrrhiza glabra (licorice) root extract
Salvia officinalis
Citrus grandis (organic grapefruit) extract
Arnica montana (organic arnica) extract
Boraxitrus seed extracts
Leuconostoc/radish root ferment filtrate
Goldseal (Hydrastis canadensis root extract)
Citrus Medica limonum (lemon) peel extract
Caprylhydroxamic acid

FDA advises its personnel not to collect "surveillance samples," but rather to limit sample collection to analysis undertaken on a "'for cause' compliance basis to document suspected adulteration or misbranding."

In cases where the adequacy of preservation is in doubt or non-traditional preservative systems are used, sample collection for microbiological analysis may be appropriate in the context of inspections or probes into suspected product-labeling violations, the agency suggests.

FDA says reports of serious adverse events underscore the importance of effective product preservation, particularly with respect to eye-area products (especially those that are water-based), skin lotions and no-alcohol mouthwash.

The agency encourages inspectors to review manufacturer records to ascertain the identity and level of preservatives intended for products, and to verify that batch records reflect the preservatives' addition to each formulation.

Inspectors should zero in on products for which documentation of challenge tests – which involve inoculating products with bacteria, molds and yeast to determine their ability to inhibit microbial growth – cannot be produced, FDA says.

In assessing potential contamination risks, "mode and frequency of product application and container design, among other factors, are also taken into consideration," the agency notes.

As in the previous version of the compliance guide, FDA provides a list of preservative compounds "commonly used in cosmetics," including parabens, quaternium-15, diazolidinyl urea, sodium benzoate, DMDM hydantoin and methylisothiazolinone.

Industry experts have suggested that virtually all of the preservatives on FDA's roundup – which consists of just 15 entries – are endangered, either due to tightening regulatory restrictions or consumer pressure on manufacturers to discontinue use ([A#02150601003]). Growing use of non-traditional preservatives has come as a reaction to the trend as conventional options dwindle.

FDA also provides an inventory of "other substances used as preservatives in cosmetics," including benzyl alchol, benzoic acid, salicylic acid, triclosan and triclocarban.

Hair Straighteners Among 'High Risk' Products

According to the guide, other "high risk" products associated with serious adverse events include tattoo inks/permanent makeup, hair straighteners and seasonal products (e.g., face paints and tanning products).

Tattoo inks are a new addition to the compliance program. In recent years FDA has been stepping up its enforcement work and consumer outreach regarding tattoo inks due to reports of local and systemic infections associated with products contaminated with pathogenic microorganisms, it indicates.

FDA notes that hair straightener use can lead to adverse events if product labeling does not adequately ensure safety. The agency's experience with the Brazilian Blowout Acai Professional Smoothing Solution – manufactured by GIB, LLC, which received a warning from the agency in 2011 regarding the product's labeling and methylene glycol content – may have prompted the increased attention Also see "FDA Warning To “Formaldehyde-Free” Brazilian Blowout Cites High Methylene Glycol Levels" - HBW Insight, 12 September, 2011..

More recently, the agency warned Van Tibolli Corp that labeling instruction for its GK Hair Taming System with JUVEXIN was not sufficient to minimize exposure risk to formaldehyde released by its methylene glycol-containing formula during the heating and application process Also see "FDA Warns Brazilian Blowout-Like Brand For Undeclared Formaldehyde Risks" - HBW Insight, 23 September, 2015..

An FDA spokesperson said the compliance program's revision was undertaken per routine agency procedures.

FDA Has Eye On 'Non-Traditional Preservative' Use, Updates Internal Guide

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