Color Additives: Current Thoughts on Biological Safety

Don R. Pohl

Senior Principal Scientist

NAMSA

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Overview Basis for Concern - Why does it appear the FDA

is asking about colorants? Significance of listing colorants in CFR Role of biocompatibility Role of vendor supplied information Role of extractables testing and risk assessment

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Basis for Concern

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There are three key items that help answer why colorants are a present concern

Information from FDA website FDA comments from deficiency statements and discussions with

reviewers Draft Guidance released April 23, 2013 regarding replacement for

Blue Book Memorandum #G95-1

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FDA Website The following are some of the documents on FDA’s

website that discuss the use of colorants: Food, Drug and Cosmetic Act Code of Federal Regulations FDA Public Health Advisory

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Role of Biocompatibility

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“Complete” biocompatibility testing of final devices are not enough in all cases

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Depending on information available, more biological data may be needed: genotoxicity, reproductive toxicity and/or carcinogenicity. ADME mentioned as well

Vendor biocompatibility data may be useful, but not enough to answer everything

Biocompatibility testing alone may not be sensitive enough to address the issue

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Role of Vendor Supplied Information

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Data from vendor of the color additive is imperative

Identity of each specific color additive is needed in the device

Information allows risk of the color additive to be initially assessed

Lack of identity does not allow for assessment to be performed as risks cannot be established

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Role of Extractables Testing and Risk Assessment

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Risk Assessment can play two roles in this process Initial evaluation of what is known If exposure is possible, can evaluate if 100% is

available what is the risk Extractables Testing

Becomes the source of additional information FDA has commented on several approaches to

extractables testing of color additives

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To view the full series about Color Additives: Current Thoughts on Biological Safety Visit NAMSA Seminars

For information about the services NAMSA offers Check out the pages on our website on Biocompatibility

or Material Characterization & Analytical Chemistry Download our Biocompatibility brochure or our

Extractables/Leachables brochure If you have any questions or would like to request a quote

Contact us at clientcare@namsa.com.