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

Recent FDA Guidance on Beverages, Liquid Supplements & Their Ingredients

In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages (http://tinyurl.com/m443cla) and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (http://tinyurl.com/nhwqz26).  I will discuss the guidances in detail below but will start with the parts that are particularly interesting:

First, in addition to outlining the attributes that FDA will consider when determining whether a product is classified as a beverage or a liquid dietary supplement, the guidance on distinguishing beverages and dietary supplements also provides some interesting comments on the types of claims that may be used on beverage labels. The guidance notes that in addition to authorized health and nutrient content claims, certain structure function claims may also be made about conventional beverages.  However, FDA reminds the reader that structure function claims on foods and beverages are only permissible when the claimed effect derives from “the product’s character as a food—its taste, aroma or nutritive value.” The document goes on to state that if the structure function claim promotes the product for another use that may involve a physiological effect, then the product may be considered a drug.  This is not a new provision.  Past conversations I have had with current and former FDA staff members indicated that “nutritive value” refers to conventional nutrients such as carbohydrates, fat, protein, fiber, vitamins and minerals. This makes me wonder whether this guidance indicates that FDA objects to claims about gut health and digestive regularity as seen on some yogurt and fermented beverage products.  

FDA issued a draft guidance on liquid supplements in December of 2009.  The 2014 final guidance issued this week is not significantly different from the 2009 draft but does provide some additional detail and clarifying examples.  So how are liquid supplements and beverages differentiated?  The new guidance lists the following criteria to consider when determining the classification of a liquid product for ingestion:

1.    Product labeling and advertising.  If the product is promoted to “refresh” or “rehydrate”, then it is a beverage even if its label includes a supplement facts box.

2.      Product names.  If the product name includes terms such as “beverage”, “drink”, “water” or “soda”, the product is a beverage, not a dietary supplement.  FDA notes that the term “tea” is not used exclusively for beverages; implying that some teas may be dietary supplements but the other criteria must also be considered.

3.      Product packaging size, shape, color, design, whether it is recloseable and the volume it holds is a factor to be considered in classifying a product as a beverage or liquid supplement.

4.      Serving size and recommended intake.  The guidance states that Americans consume about 1.2 liters of water and other beverages daily.  If the serving size of a liquid product makes up a significant portion of 1.2 liters, then the product would be considered a beverage and not a liquid dietary supplement.

5.      Recommendations and directions for use. If a product is recommended to quench thirst, it would be a beverage.  If the directions were similar to ‘take one tablespoon three times per day, it is probably a dietary supplement.

6.      Marketing practices. Advertising that compare the product to other beverages or suggest that it can substitute for a beverage or if metatags are used that bring the product up in searches for beverages, then the product is a beverage and not a dietary supplement.

7.      Composition.  FDA noted that simply adding a dietary ingredient that is only permitted in dietary supplement products to a conventional food does not transform that food into a dietary supplement.  The agency gives the example that adding ginkgo to a conventional beverage does not cause that product to be classified as a dietary supplement.

8.      Other information including information found in patents or filings with the Security and Exchange Commission.

The guidance also states that powders and premixes can be either for beverage or dietary supplement purposes.  It is also important to note that the guidance discusses the fact that food ingredients must be either GRAS (generally recognized as safe) or approved food additives. GRAS ingredients and approved food additives may typically be used in dietary supplements.  However, the caveat is added that these GRAS ingredients and approved additives must be used in accordance with the regulations that stipulate the approved amounts and uses, a condition which is frequently ignored. 

The discussion of GRAS ingredients, approved food additives and dietary ingredients echoes the second guidance document that FDA published on January 13, 2014.  FDA’s purpose in issuing this guidance is “to remind manufacturers and distributors of conventional foods about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional foods, including beverages.” The guidance states in part,

“We are concerned that some of the novel substances that are being added to conventional foods, including beverages, may cause the food to be adulterated because these added substances may not be GRAS for their intended use and are not being used in accordance with a food additive regulation prescribing conditions of safe use. In addition, some substances that have been present in the food supply for many years are now being added to conventional foods at levels in excess of their traditional use levels or in new types of conventional foods. This trend raises questions as to whether these higher levels and other new conditions of use are safe.”

My interpretation of this is that FDA is eyeing the growing use of caffeine in a variety of products.  The regulation on the use of caffeine (21 CFR 182.1180) states,

(a) Product. caffeine.

(b) Tolerance. 0.02 percent.

(c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice.

Clearly there are many products caffeine-containing products on store shelves today are not cola beverages and many contain much more than 0.02% caffeine. 

Similarly there are regulations regarding the fortification of foods and beverages with vitamins (21 CFR 104.20).  This guidance may well serve to remind manufacturers of vitamin-containing drinks and other functional foods and beverages of the restrictions on adding vitamins to those products.

This guidance also notes that binders, excipients and fillers used in dietary supplements must conform to the approved uses for additives or be used in accordance with their GRAS intended uses. 

While FDA states in both of these guidances that they “do not establish legally enforceable responsibilities” I read both guidances as a heads up to industry to review the regulations covering the ingredients used in their products and also to review the classification of any liquid products offered for sale.

It is my hope that you will find these occasional updates helpful. 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.

All the best to you!

Evelyn & Associates

www.FDALabels.com  

www.BioTransApp.com