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

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).

FDA to Inspect Foreign Firms

Hello!

I hope this brief update finds you well.  Here in the US Summer’s heat is unrelenting and FDA is turning up the heat also.

I learned today that FDA has issued letters to foreign food facilities that they will be inspected between October 1, 2010 and September 30, 2011. What does this mean for you? 

If you are outside the US and you manufacture, warehouse or distribute food or dietary supplement products that are imported to the US, you must respond to the FDA letter or risk having your registration terminated and any imports detained at the border.  You will only receive such a letter if you are properly registered. 

If you are outside the US and are not properly registered, this move on the part of FDA could mean that your products are immediately subject to detention since FDA has announced their intention to enforce the facility registration requirement.

If you are a US company but use imported ingredients or sell imported products, your purchases may be subject to detention if your supplier / manufacturer is not registered.

The registration process is simple and can be completed online by following this link:

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm

FDA does not charge a fee for facility registration but you must provide the following information:

1. Facility name, address, phone number, and emergency contact phone number
2. Parent company name, address, and phone number (if applicable)
3. Name, address, and phone number of the owner, operator, or agent in charge
4. All trade names the facility uses
5. Applicable food product categories, as listed on the registration form
6. Name, address, and phone number of a foreign facility’s U.S. agent, and phone number of the facility’s emergency contact if it is someone other than the U.S. agent
7. Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so

At your request, I would be pleased to send you a PDF copy of the Registration form that you may mail or fax to FDA along with an electronic booklet describing the process.  If you need help with your registration, the team at Bioscience Translation & Application can help.  We can facilitate the registration process, serve as your US agent and help you with other communications with FDA. Visit us at www.BioTransApp.com

FDA Promising Increased Scrutiny of Imports

Hello!

Trade newsletters are reporting that FDA Commissioner, Dr. Margaret Hamburg’s remarks at the Food and Drug Law Institute conference discussed her priority to respond to the increase in adulterated and misbranded imported food products.  Many of our clients have noted the increased scrutiny of products at the US border.  Products that had been successfully imported for a number of years are now being detained due to increased inspections.  Product from new importers into the US are basically guaranteed that their import will be held for inspection, which may include testing to ensure that levels of nutrients declared on labels are met as well as to determine whether the product is contaminated with bacteria or even laced with pharmaceutical compounds.

At the same conference, FDA Associate Commissioner for the Office of Regulatory Affairs, Michael Chappell, noted that in 2010 FDA has already issued a record number of warning letters to companies importing, manufacturing and distributing FDA-regulated products.  Many of these have gone to food, dietary supplement and cosmetic companies. The importance of FDA inspections is apparent since, as stated by FDA Chief Counsel, Ralph Tyler, 25% of the US economy is comprised of FDA-regulated products.

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At Bioscience Translation & Application your success is our success and we work with our clients to ensure compliance with FDA regulations.  Contact us for product development, labeling and claim substantiation help with your FDA-regulated products or visit us at www. BioTransApp.com

Insight from and FDA Staffer

Hello!

This message is going out to clients & friends of Bioscience Translation & Application.  A few days ago I sent the following tweet on Twitter:

Interesting talk w FDA staff-Lots of new inspectors & General Counsel is signing off on warnings & actions much faster-expect more activity!

I’ll flesh it out for you.  In an informal conversation with a current FDA staff member I learned that the agency is expecting to issue many more warning letters and to follow up on those warnings much more quickly.  Why is this?  First, last fall the agency hired hundreds of new inspectors.  This was in response to the many issues that had come up previously—adulterated heparin and food ingredients to name only two. 

The second and probably most important reason we should expect to see much more enforcement activity from FDA is that with the change in administration, the Health and Human Services Office of General Counsel, which must approve every warning letter and other action, is processing these actions at lightening speed. In the past, warning letters could wait six months or more for approval.  However, a warning letter that went out in early June 2009 was the result of an inspection that took place in mid-May 2009. 

The person I spoke with was delighted with these changes and hopeful that FDA will be able to readily fulfill its mandate to protect public health, particularly since the agency is expecting a 30 to 50% increase in their operating budget.

Since no one is perfect, what does this mean for you and your company?  Do you need to tighten up your GMP processes—perhaps review SOPs?  Is it time to review your marketing programs and labeling?  Contact us if you think you need to do anything other than relax and enjoy summer! www.BioTransApp.com