Next Steps in Cosmetic GMPs

John Gasper

Office of Cosmetics and Colors

FDA

October 26, 2016

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Outline

• History of GMP Guidance

• International Cooperation on Cosmetics Regulation (ICCR)

• International Snapshot

• FDA’s Revised Guidance

• Related FDA Cosmetics Authority

• How FDA Uses GMP Guidance

• Next Steps?

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History of Cosmetics GMP Guidance

• Status

– U.S. FDA

• Cosmetic GMP Guidelines go back to at least 1991 and were most recently revised in 2013

• No GMP regulations

– ICCR-1 (2007)

• Recognized the importance of GMP and need to work towards a common approach

• Seeks convergence of regulatory policies and practices

www.fda.gov

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ICCR Outcome

• ICCR members, 2007, commit to take ISO 22716 GMP into due consideration when developing or updating guidelines or other measures addressing GMP

– EU adopts a European standard modelled after the respective ISO standard, 2011

– Canada creates GMP guidelines taking into consideration the ISO standard, 2010

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ICCR Outcome (continued)

– Japan recognizes the voluntary guidelines updated in light of ISO, 2010

– U.S. takes into consideration the availability of the ISO standard when revising draft guidance beginning in 2008 and published as draft, level II guidance in 2013 on FDA.gov

• So where are we now?

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International Snapshot Jurisdiction Mandatory/Voluntary GMP Uses ISO 22716

EU Mandatory Yes

ASEAN Mandatory Yes

Korea Mandatory* Yes

Brazil Mandatory No

Canada Voluntary Yes

Japan Voluntary Yes

Taiwan Voluntary Yes

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2013: FDA Revised the Guidance

• Published Draft Guidance for Industry: Cosmetic Good Manufacturing Practices

– FDA’s current thinking on cosmetics GMP

– As part of an international harmonization effort with ICCR, we agreed to consider ISO 22716

– Incorporated, modified, or excluded specific aspects

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2013, Revised Guidance cont.

• Incorporated: definitions, documentation and internal audit.

• Modified: definitions

• Excluded wastes, subcontracting, majority of definitions, organization chart, management responsibilities.

• Greater revision may have led to level I guidance requiring significant review and resources

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Draft Cosmetics GMP Guidance

– Highlights of what’s been added:

• Definitions section – Documentation, GMP, internal audit, SOP

• Documentation section

• Internal Audit section

• Changed “Complaints” to “Complaints, Adverse Events, and Recalls”

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How FDA Uses the Draft Guidance

• Compliance activities and inspections:

– Domestic product inspections

– Imported product detentions

• Domestic:

– Food Compliance Programs: provide instructions to FDA personnel for conducting activities to evaluate industry compliance with laws administered by FDA

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Related FDA Cosmetics Authority

• In comparison to other FDA-regulated products:

– Companies not required to register facilities

– Companies not required to register products or ingredients

– FDA does not have mandatory recall authority of adulterated or misbranded products

– Companies not required to submit adverse event reports to FDA

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Domestic Product Inspections

• Cosmetics Compliance Program

– Found under the Food Compliance Program

– Program # 7329.001, Cosmetics Program; Import and Domestic Implementation

• (http://www.fda.gov/downloads/Cosmetics/Guidance

Regulation/GuidanceDocuments/UCM208412.pdf)

– Special Instructions

– Part III-Inspectional

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Program 7329.001-Chapter 29 • Special Instructions: conduct review of cosmetics

according to instructions provided in Part III

• Part III-Inspectional – General guidelines for the areas to be covered during

activities conducted under this program can be found in the document entitled “Cosmetic Good Manufacturing Guidelines” (gives web link to Guidance). Items covered under this program include building and facilities, equipment, personnel, raw materials, production, laboratory controls, records, labeling, and complaints.”

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Guidance as a Tool for Inspections

– FDA inspects versus the guidance

– Non-compliance with the Cosmetics GMP Guidance is not the basis of a violation of the Act

• The Cosmetics GMP Guidance is not a regulation

– Depending on what is found during inspection, FDA develops a case using BAM and the Inspection Manual

• For example, FDA has to prove a product is adulterated

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Bacteriological Analytical Manual (BAM)

• Chap 23 Microbiological Methods for Cosmetics

• FDA analyzes via BAM methods looking for microorganism growth

• Relationship to GMP guidance:

– Ex. should include specifications for absence of microorganisms

– testing for adequacy of preservation

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Warning Letter Example Related to GMP Issues

• Warning Letters Cite Cosmetics as Adulterated (posted on www.FDA.gov)

– “FDA conducted an inspection of your manufacturing facility in response to a Class II Recall”

– “It appears that adequate testing was not performed, as your firm could not provide the documents for FDA review”

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Warning Letter, cont.

– “FDA notes that quality control testing of incoming materials is a fundamental part of cosmetic good manufacturing practices…”

– “We note that, in our Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetics, we recommend a number of guidelines for effective self-inspection that may assist cosmetic manufacturers to minimize the risk of adulteration”

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Imported Cosmetic Products

• Detained Without Physical Inspection (DWPE)

• Import Alerts

• DWPE: detained at port and denied entry for appearance of adulteration – Packaging is compromised

– Product is on Import Alert • See “Information for Cosmetic Importers”

– http://www.fda.gov/cosmetics/internationalactivities/importers/default.htm

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Decision to Allow Entry

• FDA can ask the company GMP related questions to help decide whether to allow entry

– How was the product controlled/handled?

– How was it processed?

– How will it be used?

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Import Alerts-Removal

• Regulatory Procedures Manual: on FDA.gov

– Procedures used in processing domestic and import regulatory and enforcement matters

• FDA wants confidence that the conditions that gave rise to the apparent violation have been resolved and that future entries will be in compliance with FDA laws and regulations

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Import Alerts-Removal

• Supply information on at least 5 entries

– These are subsequently analyzed/examined and found to be no longer in violation

• Must petition to be removed from DWPE

– Outline corrective actions and steps taken to prevent the problem which led to Import Alert

– Can be based on reconditioning, which is GMP related

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Next Steps in Cosmetic GMP?

• Possible options:

– Voluntary GMP

• FDA and manufacturers follow current draft Guidance – Variability in GMP’s followed amongst manufacturers

– Mandatory GMP

• Under discussion in some proposed Congressional bills

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Conclusions

• While cosmetic authority is limited, FDA uses the Draft Guidance as a compliance tool

• 2007: ICCR recognized importance of GMP and working on a common international approach

• Today: ISO 22716 is being used internationally in both a mandatory fashion and also voluntarily

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Thank you!

• Questions?