FDA Update Purchasing Controls

Last week I attended a meeting with FDA staff from the Denver District Office.  The meeting was an annual update from FDA addressed to the members of the Rocky Mountain Regulatory Affairs Society.  Since most of the members work with medical devices, the speakers from FDA focused on that industry sector and in particular talked about Purchasing Control Regulations since failure to comply with them results in a large number of failed inspections, warning letters and product recalls each year. The term “Purchasing Controls” is only used in the regulations for medical devices but the language of these regulations are informative for dietary supplement, food and cosmetic companies as well. 

The regulations covering good manufacturing practices (GMPs) for dietary supplements commonly use the phrase, “ensure that the [product, components, labels and packaging] are consistent with your purchase order”.  The GMP regulations for foods and the GMP guidance for cosmetics both refer to specifications for ingredients.  Since it is impossible to consistently make quality products unless you have ingredients of consistent quality, it is imperative that your purchasing department have detailed information about the requirements for each ingredient or component used in your product.  In other words, purchasing needs detailed ingredient/component specifications. 

Let’s take a brief look at the medical device purchasing control regulations to learn more:

21 CFR 820.50(b) states, “Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services…”

This could mean that the herbs you purchase must be accompanied by chromatograms that document the amounts of key phytochemical components.  It may mean that you must list a range for the required viscosity of certain oils to ensure that your cosmetic will have the right thickness.  In the case of a food ingredient such as cayenne pepper, it may be important to define the acceptable Scoville Heat Units so that the final product will live up to your label claims of mild, medium and hellfire.

21 CFR 820.50(b) continues, “Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.

This is a very important consideration for companies that are using contract manufacturers.  Your contract with your manufacturer should explicitly define not only which ingredients may be substituted but what substitutions are acceptable and that you are to be notified when the manufacturer finds it necessary to make any change to your product.

As specified in the device regulation, the best way to ensure that you always get quality ingredients and services is to first set requirements/specifications for your ingredients, components and service providers and then evaluate their ability to meet your requirements before you contract with them. If your company has purchasing controls that are followed and followed up on by the quality and manufacturing departments it is far more likely that the products, components, labels, etc. will be consistent with your purchase order and meet your specifications.  That in turn will please your customers!

I started my consulting business in 2001 after 15 years working in FDA-regulated industry.  Since that time my colleagues and I have served hundreds of dietary supplement, food, cosmetic and device companies from around the globe.  My colleagues and I are ready to help you determine which FDA regulations apply to your product and what you need to do to comply with them. Contact us today by replying to this message.

As always, we hope you find these occasional updates interesting. 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.

All the best to you!
Evelyn & Associates
www.FDALabels.com
www.BioTransApp.com

What's not to like on Facebook? FDA's View

Sometimes FDA and other government agencies seem to be a bit behind the times but just last week FDA published the 19^th warning letter to mention Facebook.  Some of these letters from the past three years have also cited Twitter and Tumblr as sources of violative claims.  While these letters were primarily directed at dietary supplement companies, food, cosmetic and even drug companies can easily run afoul of FDA regulations on social media sites.

The most recent warning letter to mention Facebook, which was sent to Zarbee’s Inc. of Draper, UT. not only cites the company’s own Facebook postings but notes that “Zarbees “liked” the following comment...” and goes on to quote from customer posts noting how well the products worked for coughs, insomnia and other ailments.   In 2012 FDA had disliked the like that AMARC Enterprises, Inc. of El Cajon, CA gave to one of its customer’s posts about using their dietary supplement product for cancer.

The concept that testimonials presented on company websites and in other marketing materials are claims that are subject to regulatory scrutiny is not new.. In 2009 the Federal Trade Commission (FTC) issued a guidance document on testimonials and endorsements in advertising http://tinyurl.com/kdxnoqa  noting that they, like all marketing claims must be truthful, not misleading and supported by data.  FDA expands requirements for endorsements and testimonials to require that they comply with regulations on allowable claims.

All companies like positive comments and testimonials from customers.  While consumer comments are not a new phenomenon, the consumer’s ability to publish their comments to the world on social media sites is new.  So what is a company to do when a happy customer posts something that makes a claim that violates the regulations governing the compliant marking of their product?  

Several of the Facebook warning letters included this note from FDA,

“We advise you review all the information on your websites, including testimonials, social media websites (e.g., Facebook and Twitter), product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the FD&C Act. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.”

The last sentence makes it clear: Companies must closely monitor their social media for compliance with FDA regulations. If a post about a product goes beyond what is allowed by regulation, the posts must be deleted or edited to become compliant.

·        If you are a dietary supplement company and a customer posts that your product cured an ailment or relieved pain; your product just became an unapproved new drug subject to FDA enforcement.

·        If you are a cosmetic company and a happy customer states that your oil healed their skin condition, that oil just became an unapproved new drug subject to FDA enforcement.

·        If you are selling an OTC drug and a customer posts about a use that is not covered in the approved labeling of your product, you are also subject to FDA enforcement action.

My colleagues and I can help you stay out of trouble by reviewing or monitoring your website and social media posts, as well as your product labels and brochures for FDA compliance.  Contact us with your questions.

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

All the best to you!

Evelyn & Associates

www.FDALabels.com 

www.BioTransApp.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.