FDA Update on Importing Cosmetics

FDA recently updated the web page, “Information for Cosmetic Importers.”  This document uses a question and answer format and the update offers some clarification on the use of INCI (International Nomenclature Cosmetic Ingredient) names for cosmetic ingredients:

Is INCI nomenclature acceptable for identifying botanical ingredients?

INCI (International Nomenclature Cosmetic Ingredient) names for botanical ingredients typically use Latin names for genus and species to identify botanical ingredients. U.S. regulations require the use of common or usual names. Latin terms may be included parenthetically following the common or usual name of an ingredient. Example: Aloe (Aloe Barbadensis) Extract. See “FDA Response to CTFA Requests Regarding Harmonization of Ingredient Names (Color Additives, Denatured Alcohol, and Plant Extracts).”

It is very helpful to have this information spelled out by the agency since previously I and others have received conflicting information from the agency on the use of INCI names.

The related topic of C.I. numbers (used in European labeling) is also covered in the update:

Are C.I. numbers acceptable for identifying color additives on cosmetic labeling?

C.I. numbers are not acceptable on product labeling unless they are preceded by the color additive names accepted in the U.S. followed by the C.I. number in parentheses. In addition, C.I. numbers do not indicate FDA approval or FDA color certification. To learn more, see “Color Additives and Cosmetics” and the additional resources listed on that page.

Unfortunately, FDA has not been able to provide true clarity for what ingredients are and are not allowed in cosmetic ingredients.  The import update states that not all ingredients permitted use in cosmetics sold outside the US are permitted in the US and links to a very short list of prohibited ingredients.  But the update goes on to state, “But remember, any ingredient is prohibited if it causes the finished cosmetic product to be unsafe for consumers under labeled or customary conditions for use, even if there is no regulation specifically prohibiting or restricting its use in cosmetics.”  The associated link leads the reader to the brief list of prohibited ingredients and this Q&A:

Are these the only ingredients that can cause a product to become violative?

No. A product may become adulterated or misbranded in a number of ways. Among these are improperly used color additives or any ingredient, other than a coal-tar hair dye, that causes a cosmetic to be harmful under customary or usual conditions of use, or cause a cosmetic to become misbranded, as stated in the Federal Food, Drug, and Cosmetic Act, Sections 601 and 602. Additionally, an ingredient having a history of use in or as a cosmetic may at any time have its safety brought into question by new information.

So what is a cosmetic importer to do to determine whether an ingredient is permitted in the US?  Associates at Bioscience Translation &Application and FDALabels.com search various references and databases for safety information to provide guidance on levels of ingredients that are likely to be considered safe by FDA when reviewing cosmetic formulations for clients.  We are ready to help you with your questions about this or our other regulatory affairs services.

These blog pots are also sent as Informational emails to our subscribers.  If you would like to subscribe to our periodic updates on foods, dietary supplements or over the counter drugs, reply to this post.

Labels as Tables of Contents

Greetings!

Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc (http://www.nosco.com/), presented information on packaging, labeling and compliance.  I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that can guide an inspection of your manufacturing facility.  For instance, the net contents statement clues an inspector in on the type of equipment they will be reviewing: liquid or powder fill, tableting or encapsulation.  Whether the product is a food, drug, cosmetic or dietary supplement, the statement of identity, along with product claims, determines which regulations apply.  Claims used on the product label also convey the amount and type of data that should be on file to support the claims so that you can comply with the requirement that all claims be truthful, not misleading and supported by data.

If the product is a dietary supplement, the supplement facts box outlines the manufacturing process.  If the facts box lists a proprietary blend, then the standard operating procedure or SOP should reflect a blending step.  The supplement facts box can provide a list of herbs that may require identity testing or that may need to be the subject of a new dietary ingredient notification. Nutrition Facts boxes on foods or Drug Facts boxes on over the counter drug products guide inspectors to look for data to support the values declared or to demonstrate adherence to applicable monographs.The ingredient list is another place when an inspector may look for ingredients that may not be permitted in products marketed in the United States.

Finally, the signature line listing the name and place of business of the company introducing the product into the marketplace, assigns responsibility for compliance with labeling regulations, good manufacturing practices and adverse event reporting system. In the event an inspector finds something amiss, the signature line names the company that will get the 483 or possible warning letter.

With so much riding on the information listed on your product label, don’t ignore the importance of ensuring that your labeling is correct and complies with FDA regulations.   Visit our websites, www.BioTransApp.com or www.FDAlabels.com for more information on labeling or other FDA compliance issues.  This blog discusses issues pertinent to FDA-regulated industries. Post a comment to let us know if you would like to subscribe to occasional email updates targeted to your industry sector.


Copyright 2011 Bioscience Translation & Application

Warning Letters: Gelatin and Water as Dietary Ingredients

FDA warning letters continue to provide information that give insight into the level of detail of FDA inspection, which are relatively new to the dietary supplement industry and may help your company avoid problems when your inspection comes up.

In a February 9, 2011 letter to Ancient Formulas of Wichita, Kansas, FDA declared some products misbranded because they did not include a complete list of ingredients.  Specifically the agency noted that the ingredients that make up the capsules were not listed.  Regulations covering ingredient declaration include 21 CFR 101.4, 101.36 and 101.100.  While there are many details in these listings the highlights are as follows:

Ingredients that must be declared:

101.4 (a)(1) Ingredients required to be declared on the label or labeling of a food…shall be listed by common or usual name in descending order of predominance by weight …

101.4 (g) …Ingredients in dietary supplements that are not dietary ingredients or that do not contain dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders, shall be included in the ingredient list.

Section 101.100 lists ingredients which do not have to be listed: “Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food.”

In the letter to Ancient Formulas, FDA listed ‘gelatin’ as an example of an undeclared capsule ingredient but depending upon what the capsule supplier lists, there may be need to declare other ingredients.  Softgels often contain colorants and other excipients and most capsules also list water as an ingredient, which should be declared on the label.  

Speaking of water, another dietary supplement manufacturer, Abba Pharmaceuticals of Tampa, Florida, also received a warning letter with the unique citation that they failed to a) establish specifications for water as an ingredient in the liquid dietary supplement product and b) they failed to determine and keep records demonstrating that water used as a dietary supplement ingredient conformed with local, State and Federal regulations and would not contaminate the dietary supplement. (21 CFR 111.15 & 111.23).

Many of you have heard me say that a product label is really a table of contents of how the product was manufactured.  They way ingredients are declared describes how those ingredients were added and mixed. When reviewing your labels, the team at Bioscience Translation & Application looks beyond the label itself to alert you to the regulatory implications for your manufacturing process.  The warning letters discussed above provide examples of why this is important.  Let us help you ensure that your labels are correct and that your processes are FDA compliant.

To read the warning letters in their entirety, visit http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#browse and search on the company names.  To read the regulations cited above, search using the section numbers cited at  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm .

We send targeted email newsletters to various groups of our clients.  To receive newsletters on topics such as foods, cosmetics, drugs, dietary supplements and medical devices, leave a comment to this blog post with your email address (your email address will not be posted to the public).