Revised FDA Guidance on Cosmetic GMPs

The weather is changing as a new season begins and it’s time to review recent FDA activity in the cosmetic sector.  In June 2013 FDA published a draft guidance revising the Good Manufacturing Practices for cosmetics. While these GMPs remain voluntary, FDA Agents will use these guidelines when inspecting cosmetic facilities.

FDA first published cosmetic GMP inspection guidelines in 1997 and updated them in 2008. FDA participates in the International Cooperation on Cosmetic Regulations (ICCR) and this latest update incorporates portions of the International Organization for Standardization’s (ISO’s) current standard for cosmetic GMPs (ISO 22716:2007)

The new guidance expands the section on documentation and record keeping; placing this information at the beginning of the guidance.  The sections on facilities, equipment, personnel, raw materials, production and laboratory controls are expanded as well.  There are new sections on water used as an ingredient, color additives and prohibited cosmetic ingredients. 

The section on water used as a cosmetic ingredient states in part that the water is to be of defined quality and is to be tested or monitored to verify that it “meets applicable chemical, physical and microbiological specifications for quality”.  It is also noted that the water system “should be routinely cleaned and sanitized according to an appropriate SOP that ensures no biofilm build-up.”

Surprisingly, the new guidance omits the section on labeling that was included in the older version.  It is unlikely that FDA inspectors will skip label reviews during an inspection since labeling requirements are codified in regulations.  

Although the revised draft guidance does not have the force of law, if it is followed, it can help you ensure that your production facility would pass inspection.  The full guidance may be viewed at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm353046.htm?source=govdelivery.

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Kind regards,

Evelyn & Associates

www.BioTransApp.com

www.FDALabels.com

 

Quality Agreements with your Contract Manufacturer

It has been a while since we have sent any updates for our dietary supplement clients.  The FDA has remained busy inspecting supplement companies and writing many, many warning letters. The regulations for dietary supplement Good Manufacturing Practices (GMPs) include a section on quality control requirements (21 CFR 111.103 – 111.40).  Many dietary supplement distributors mistakenly think that quality control is the responsibility of their contract manufacturers.  There have been a number of warning letters to companies who failed to have sufficient oversight or documentation of the system in place to ensure that their contract manufacturer was producing the product specified.  A recent letter to Body Systems, Inc. of Winter Springs, FL delineates this responsibility and in addition states that failure to fulfill this responsibility can result I criminal liability:

“Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.”

An initial step for dietary supplement companies to take in order to address their responsibilities is to carefully write the contracts and agreements they have with their contract manufacturers. This week FDA issued a draft guidance document on quality agreements for the drug industry. While reading through it, I thought that many of the suggestions are relevant to the dietary supplement industry.  The draft guidance discusses how both the ‘Owner’ of the product and the contract manufacturing facility are responsible for quality control and compliance with GMP regulations.  The same is true in dietary supplement manufacturing.  In the following excerpt from the draft guidance on quality agreements, think “dietary supplement” when you read “drug.” (Note that I have separated theses sentences for emphasis but they appear in a single paragraph in FDA’s document.)

“In all cases, the Owner is responsible for assuring that drugs introduced for interstate commerce are neither adulterated nor misbranded as a result of the actions of their selected Contracted Facilities.

All Contracted Facilities must assure compliance with applicable Current Good Manufacturing Practices for all manufacturing, testing or other support operations performed to make a drug(s) for the Owner.”

The second sentence states that the contract manufacturer must assure compliance with GMPs. While first sentence states that the company that will introduce the product into commerce, the “Owner” must take steps to ensure that the product has been properly manufactured.  This requires auditing of the manufacturing process by the Owner to ensure that the manufacturer is fulfilling the contract.  It may be helpful to read the full guidance here.  At the very least, it can provide things to think about as you work with your contract manufacturer.

My associates and I hope you find these occasional updates helpful. If you would like to subscribe to our newsletter updates on foods, cosmetics, dietary supplements or over the counter drugs, simply reply to this post and let us know.

Contact us if you have questions or need help ensuring that your company is in compliance with FDA regulations.

Sincerely,

Evelyn & Associates

Wrinkles and FDA Cosmetic Update

It has been many months since we’ve posted anything on cosmetic regulations. This edition is to make you aware of recent FDA enforcement actions and some proposed legislation that you should be aware of.

We have had discussions with many of our clients about ‘wrinkle claims’.  Typically we note that cosmetic regulations allow claims regarding how a product cleanses, beautifies, promotes attractiveness, or alters appearance or fragrance and that claims about wrinkle reduction are therapeutic or drug claims.  Many of you have responded with questions similar to ‘what about all the big guys and the stuff they say in their commercials?’  Well, a few of the big guys received warning letters from FDA regarding their claims.

In October FDA sent Avon a warning letter regarding claims made on their website about their Anew line of products. The letter lists a number of claims including

“Rebuild collagen to help plump out lines and wrinkles.

Stimulate elastin to help improve elasticity and resilience.

Regenerate hydroproteins to help visibly minimize creasing.”

The letter also notes claims comparing Avon products to botox and goes on to say, “Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the [Food Drug and Cosmetic] Act.”

In September Lancôme also received a warning letter noting numerous drug claims on their Genefique line of products.  While one claim cited in the letter did discuss wrinkles, “See significant deep wrinkle reduction in UV damaged skin, clinically proven,” the Lancôme website claimed that their products stimulate stem cells.  It may be that it was the stem cell claims that prompted FDA to act but the fact that wrinkle claims were also cited is noteworthy.

Cosmetics may be promoted to reduce the appearance of wrinkles but not to repair, correct, plump or make them go away.

Now for the future: Last April US Congressman Leonard Lance of New Jersey introduced a Bill in the US House of Representatives.  The Cosmetic Safety Amendments Act of 2012 proposes “to establish new procedures and requirements for the registration of the cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes.” 

For a number of years FDA has had the Voluntary Cosmetic Registration Program (VCRP) in place.  This program is ‘regulations light’ but mirrors the drug listing and registration program.  I have heard rumors that cosmetic good manufacturing practice regulations have been written but have not seen them published this year; which is not surprising since much in government was on hold in 2012 due to the Presidential election and remains on hold awaiting the outcome of Congressional efforts to address looming budget cuts and tax changes. Nevertheless, it is important for cosmetic companies to be aware that they will be affected by future increased regulation.

To learn more about the VCRP, visit http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm.

To read the proposed legislation visit http://www.gpo.gov/fdsys/pkg/BILLS-112hr4395ih/pdf/BILLS-112hr4395ih.pdfhttp://www.gpo.gov/fdsys/pkg/BILLS-112hr4395ih/pdf/BILLS-112hr4395ih.pdf .

To read an intelligent and information article about the legislation, visit FDALawBlog at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/representative-leonard-lance-r-nj-introduces-industry-supported-bill-to-modernize-cosmetics-regulation.htmlhttp://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/representative-leonard-lance-r-nj-introduces-industry-supported-bill-to-modernize-cosmetics-regulation.html

To read the Avon warning letter visit http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm

To read the Lancôme warning letter visit http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htm

I hope you find these periodic posts informative and interesting.  If you  would like to be added to our newsletter distribution list, please reply to this post. 

Contact us with any questions you have regarding cosmetic, food or dietary supplement regulations.

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

Dietary Supplement Educational Opportunities

Hello!

Many of our dietary supplement clients have come to us for proactive assistance with proper labeling and other FDA regulatory issues.  Unfortunately, some companies only found us after they had problems and were subject to enforcement action by FDA.  It is expensive and time consuming to have to respond to FDA warning letters or have products held at the border.  Further, some violations raise the possibility of product recalls or even complete removal of the product from the US market.  My team and I do our best to alert our clients and help them understand the FDA’s Good Manufacturing Practices (GMP) regulations and I want to be sure you have heard about two opportunities to learn more about them.

August 22^nd from 1:00 pm to 3:00 pm Eastern Time (Webinar)

The Natural Products Association is Sponsoring a webinar on the GMPs the effect companies that distribute but do not manufacture their own products. FDA calls such companies ‘Own Label Distributors’. I believe this information is crucial for dietary supplements that want to grow and stay out of trouble with FDA. Here is a link to registration for this webinar and a brief description follows:

http://www.npainfo.org/NPA/EducationCertification/NPAGMPWebinar.aspx

FDA says that if your name is on the product, you are responsible for it. The agency has issued numerous warning letters to own-label distributors for GMP violations—Ensure your product is in compliance with GMPs by registering for this webinar. Hear directly from FDA about their expectations are for specific for own-label distributors, re-packagers, and re-labelers, and hear from our industry speaker about how to achieve compliance.

September 13^th and 14^th In person conference in Boulder, CO

Sponsored by The Rocky Mountain Dietary Supplement Forum: What Does FDA Really Expect from Us?

At this day and a half seminar you will learn directly from industry experts.

    Learn how to dramatically change the outcome of your inspection with the Agency

    Hear from FDA Denver District representatives on what they expect during an inspection plus the top 483 items trended by FDA 

    Receive step-by-step instructions and a template on how to respond to 483s and Warning Letters

    Interact with other industry professionals who are facing the same challenges you are

http://www.regonline.com/builder/site/Default.aspx?EventID=1055067http://www.regonline.com/builder/site/Default.aspx?EventID=1055067

We at FDALabels.com and Bioscience Translation & Application hope that you find this information helpful.  If however, you wish to receive these occasional posts as newsletters, please post a reply to this entry.

Meanwhile, we would be pleased to help you with your questions about FDA regulations. 

All the best to you and yours!

Evelyn