A draft revision of FDA’s outdated Cosmetic Good Manufacturing Practices recommendations reflect an effort to align with international standards.

Released June 18, the draft guidance updates cosmetic GMP guidelines created in 1997 and revised in 2008. The guidance is nonbinding, but “reflects [FDA’s] current thinking on this topic.”

The agency says international consensus formed through harmonization efforts under the International Cooperation on Cosmetic Regulations was at the fore of its mind as it developed the modernized GMPs.

According to FDA, a cosmetic GMP update was sorely needed as its predecessor, the “Cosmetic Good Manufacturing Guidelines/Inspection Checklist,” was based on documents and information prior to the early 1990s.

“This guidance is the result of a commitment that FDA made in 2007 in accord with its membership in the [ICCR],” FDA spokesman Arthur Whitmore said in an email to “The Rose Sheet.”

ICCR, comprising regulatory authorities from the U.S., Canada, Europe and Japan, discussed international alignment of cosmetic GMPs at the 2007 meeting, ultimately agreeing to base recommendations on International Organization for Standardization’s cosmetic GMPs standard (ISO 22716) Also see "ICCR Addresses Cosmetic Labeling, Nanotechnology At First Meeting" - HBW Insight, 15 October, 2007..

FDA says it took ISO 22716 as the model for its GMPs “and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience.”

According to the agency, a cosmetic GMP update was sorely needed as its predecessor, the “Cosmetic Good Manufacturing Guidelines/Inspection Checklist,” was based on documents and information prior to the early 1990s.

“Much of the material in the predecessor document has become outdated,” FDA says, noting that “there has been a great deal of progress in developing international consensus standards for cosmetics, specifically ISO 22716.”

The Personal Care Products Council applauded FDA’s development of updated cosmetic GMPs.

“The Council welcomes FDA’s issuance of its recently issued and modernized draft cGMP guidance,” Chief Scientist Halyna Breslawec said in an email to “The Rose Sheet.” “We fully support FDA’s implementation of its 2007 ICCR agreement to consider the ISO cosmetic GMP standards as part of their updated cGMP guidance.”

PCPC, along with other members of the Safe Cosmetics Alliance, support a legislative plan that would modernize regulatory oversight of the cosmetics industry. The plan directs FDA to establish industry-wide GMPs Also see "Council-Approved Cosmetics Safety Bill Launches" - HBW Insight, 23 April, 2012..

Manufacturing Guidance

While the cosmetic GMPs are not mandatory, FDA suggests that “if you manufacture cosmetics, you can reduce the risk of adulterating or misbranding cosmetics by following the GMP recommendations in this guidance. By following these recommendations, you can effectively conduct a self-inspection for your operations.”

The revised GMPs provide enhanced detail on various manufacturing guidelines including recordkeeping, buildings and facilities, equipment, personnel, raw materials, production, internal audits, laboratory controls, handling consumer complaints and reports of adverse events and conducting recalls.

Specific recommendations were added for manufacturing personnel to address safety concerns: “All personnel and visitors should be properly supervised while in the manufacturing facility, and [o]nly authorized personnel should be allowed access into production, storage and production control areas.”

Other changes include a new section on definitions, “intended to clarify terms contained in the guidance,” and one related to documentation, “which notes its role in preventing errors and correcting problems that may occur during manufacture,” according to Whitmore.

Provisions for water and color additives as cosmetics ingredients were also added to the guidance.

FDA advises manufacturers to determine if water is untreated or treated and “of a defined quality.” Moreover, processes should be in place to ensure that water is regularly tested for quality, that equipment used to supply water is often cleaned and sanitized, and that water is not itself “affected by water treatment equipment.”

In addition, color additives should be reviewed to ensure approved use in cosmetics, and certification should be sought for those yet unapproved for use in a specific product.

FDA is accepting written comments on the draft guidance at any time. Comments, identified by title of the guidance document, will be accepted by FDA’s Division of Dockets Management (HFA-305) in Rockville, Md.

ICCR Ushers Forth Updated Cosmetic GMP Guidelines From FDA

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