FDA and Cosmetic Industry Controversies: Anti-aging claims and ingredient safety

Recently the trade publication, Cosmetics Design, published two articles that caught my eye.  One discussed FDA’s Import Alert on cosmetics labeled as anti-aging creams (http://tinyurl.com/n5xq2e6).  The import alert is FDA’s guidance to their staff that inspect imported products.  FDA lists the reason for the alert as,

“There are numerous skin care products on the market with exaggerated "anti aging" claims which cause the products to be unapproved new drugs. Examples of such claims are that the products "counteract," "retard," or "control" the aging process. Claims that the product will "rejuvenate," "repair," or "restructure" the skin may also be drug claims. A claim such as "molecules absorb and expand, exerting upward pressure to 'lift' wrinkles upward" is a claim for an inner structural change that would usually cause a product to be a drug.”

The import alert instructs FDA staff to refuse entry of products with these claims.

This view of anti-aging claims, while in conflict with the marketing programs of many cosmetic manufacturers, is not new to FDA.  In December of 2012, we published a blog post (http://tinyurl.com/kntalmv) about FDA warning letters sent to Avon and Lancôme due to their anti-aging and anti-wrinkle claims.  It is important to note that while imported products have a greater chance of being subject to FDA enforcement actions based on anti-aging claims, products produced and sold domestically in the US are subject to the same rules.  As stated in the Cosmetics Design article the import alert, “is a good reminder for any company.” (http://tinyurl.com/mqrgzno).   

The other interesting article in Cosmetics Design is titled, “PCPC ‘extremely disappointed’ in FDA’s cosmetics legislation decision” (http://tinyurl.com/lsgzb8m).  The PCPC is the Personal Care Products Council and is the leading cosmetic industry group in the US.  The group has long had a cooperative relationship with FDA to determine the safety of cosmetic ingredients and has been working with FDA on potential updates to cosmetic regulations.  With a little searching I was able to find that in September of 2013 FDA Commissioner Margaret Hamburg sent a letter expressing disappointment with PCPC for being “unable to proceed toward legislation on the basis of the framework agreement” between the two sides.  Earlier this month, Deputy Commissioner Michael Taylor, sent a similar letter that also included a critique of the draft legislation proposed by the cosmetic industry (http://tinyurl.com/nydrdgv). Based on this letter it seems that the crux of the disagreement between FDA in industry is on the issue of ingredient safety. 

Industry has apparently proposed that chemicals deemed safe for use in food, drinking water, as well as some ingredients used in drugs, be deemed safe for use in cosmetics.  FDA’s position is that safety for ingestion is not the same as safety for topical use and gives examples of some that would not necessarily also be safe in cosmetics.  For example, the Deputy Commissioner notes that sodium hydroxide and ascorbic acid may be used as buffering and neutralizing agents in foods without restrictions but that both chemicals have been associated with harm to hair and scalp due to high levels that have been used in some hair straightening and relaxing products.  It should be noted that the high levels of these ingredients that would be used in hair relaxing/straightening products go well beyond buffering and neutralizing effects to make either very alkaline or very acidic solutions.  Accordingly, it seems to me that if used only as buffers and neutralizers in cosmetics, sodium hydroxide and ascorbic acid could be safe for use in cosmetics without restriction just as for food while leaving room to restrict uses at levels that exceed those neutralizing effects.  It could be very difficult and expensive for the cosmetic industry if an agreement on how to determine which cosmetic ingredients are safe cannot be reached.

Deputy Commissioner Taylor’s letter also discusses objections FDA has to industry proposals for cosmetic product registration and listing as well as for facility inspections, adverse event reporting and recalls.  I will save discussion of those other topics for another message.

All in all, it is clear from the tone of the FDA letter that there has been a breach of trust.  In fact, Mr. Taylor states, “Because your proposal meets none of the safety goals on which we had all agreed last year, I have difficulty seeing a path forward in this process.”  In the Cosmetic Design article PCPC President Lezlee Westine is quoted as responding, “We are extremely disappointed that FDA has indicated they will not participate in further discussions with the cosmetics industry regarding cosmetic legislation and have taken such a hard line approach to our efforts to operate in good faith.”

I hope for the sake of the cosmetic industry and consumers that FDA and cosmetic industry representatives can overcome their disappointment and renew the good working relationship they previously had.

As always, it is my hope that you find these occasional updates interesting and informative. If so, you may use this link http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time. Please post any questions you may have. My associates and I stand ready to help you with your FDA regulatory issues.

Best regards,

Evelyn and Associates

www.FDALabels.com

www.BioTransApp.com

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.

FDA Warning Letters to Cosmetic Companies

FDA Warning Letters to Cosmetic Companies

The US Food and Drug Administration has responsibility to ensure the safety of consumer products through enforcement of regulations on many consumer products, including cosmetics.  Cosmetics are subject to fewer regulations than are foods and drugs and it is not common to see FDA issue warning letters; however, in the past few months FDA has sent warning letters to two cosmetic companies.

In a June letter to Set-N-Me-Free Aloe Vera Company  FDA objected to therapeutic claims on the cosmetic products.  Cosmetics may be marketed to cleanse, beautify, promote attractiveness and alter appearance but not to affect the structure or function of the skin.  While in this warning letter FDA objected to some outrageous claims about cancer, it also included the following claim, which is a lot like many seen in the market today:

“Natural B-vitamins in the safflower and avocado oils [ingredients in this product] help in cell formation and build skin-immune functions. These oils renew skin flexibility by permeating natural vitamins A and E into skin cells, making regeneration of these cells occur faster.”

The claims about immune function and regeneration are problematic, going well beyond cleansing, beautifying, promoting attractiveness and altering appearance.

Last week FDA published a letter sent to Vienna Beauty Products.This was the most disturbing warning letter I have ever read about a cosmetic company. According to the letter Vienna Beauty Products were producing cosmetics under insanitary conditions that included:

“Apparent filth and dust build up on manufacturing equipment in the production area” 

“A layer of sediment and encrusted material was observed on the exterior and tops of production kettles.”

“The last cleaning [of the production room floor] was performed November 2010.”

“The 250 and 500 gallon kettles were last cleaned 15 years ago.” 

“The last cleaning of the 400 gallon shower gel kettle could not be determined.” 

“Additionally, the finished product storage tank and storage totes were said to have last been cleaned over 20 years ago.” 

Not surprisingly, these conditions led to production of products with high bacterial counts.  The scary thing is that Vienna Beauty Products manufactures several private label lines of product for major retailers.

Since registration of cosmetic manufacturing facilities is voluntary, I wondered how the FDA ever discovered all the problems at Vienna Beauty Products.  I noticed that the warning letter was signed by Paul Tietell, District Director of FDA’s Cincinnati District Office.  Mr. Tietell used to be in the Denver District Office and I had the pleasure of serving with him on the board of the Rocky Mountain Regulatory Affairs Society, so I wrote to ask him how cosmetic companies come to FDA’s attention.  Here’s his reply,

“Cosmetic establishments may find their way to FDA's OEI (Official Establishment Inventory) in a variety of ways.  

In addition to the firm registering with FDA through the VCRP, the firm may also be a manufacturer required to register under one of many existing regulations.

The firm may have been involved in a complaint (Consumer, Med-Watch other agency referral) and have been entered into our OEI in conjunction with our receiving and recording of that complaint.

The firm may have come to the attention of a FDA through general surveillance of retail sales, by observation during and employee's day to day operations, or perhaps through observation of an advertisement.”

This means that if you advertise or sell cosmetics, you could be subject to FDA inspection.  It also means that you should review your manufacturing methods against FDA's Inspection Checklist  and be sure to have your labels reviewed for regulatory compliance.

Cosmetic companies provide products to help make the world beautiful and attractive.  The folks at FDALabels.com and Bioscience Translation & Application would like to help you keep your business beautiful.  Contact us if you have questions or need help ensuring that your company is in compliance with FDA regulations.

We hope you find these occasional posts interesting and informative.  You can subscribe to our mailing list by replying to this post.

The Cosmetic Team

FDALabels.com

Bioscience Translation & Application

An Introduction to Importing FDA-Regulated Products into the US

As posted here previously, FDA has committed to greater inspection of imported products; particularly imported food and dietary supplements (supplements are regulated as a special class of foods).  

We frequently work with companies that wish to import products into the US and have developed the following list of steps necessary to do so.  Note that each step involves many sub-steps not listed here.  Many of the same steps apply to cosmetic products.  Drugs and Medical devices must first be approved or cleared by FDA for use in the US and then steps 4-7 apply to them as well.

Steps to import foods & dietary supplements into the US

       1.  Register the facility where the products are produced and held. FDA Food Facility Registration and What You Need to Know About Registration of Food Facilities

       2.  Review FDA Food Safety requirements and GMP regulations to ensure that the facilities can comply with them since registration puts you on FDA’s inspection list. See FDA webpage on Food Safety

3     3.  If your product is a liquid or gel and preserved by either a) having a low pH or b) being thermally processed, then you must register your facility (a separate registration than 1 above) and submit your processing steps for FDA review and approval prior to shipping product to the US. (Note: FDA uses the term ‘canned’ food to refer to any shelf stable product that has liquid or gel content.) Information for Aseptic Processors and Acidified or Low-Acid Canned Food Registration

4    4.   You must have a US Agent that is physically located in the US to serve as a domestic point of contact and communication with the FDA. US Agent

      5.  You must ensure that your product ingredients are permitted in the US. Unfortunately, there is not a comprehensive list of what is or is not permitted and not everything that is permitted in the EU is permitted in the US. Even FDA's Everything Added to Food in the United States is only a partial list.

i      6.  You must ensure that the product label is in compliance with FDA regulations FDA Food Labeling Guide; Dietary Supplement Labeling Guide; Cosmetic Labeling Guide

      7.  You must notify the FDA of your shipments so then can be inspected upon import. Prior Notice of Imported Foods

NOTE: This list only covers FDA’s side of importing. US Customs and Border Protection has other regulations which are outside of our expertise.  We recommend that you work with a reputable Custom Broker to ensure compliance with those other import regulations.

We at Bioscience Translation & Application and FDA Labels.com hope that you find this information helpful. Contact us with question or post a comment.