Search This Blog

Monday, November 17, 2014

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

Monday, October 6, 2014

Updates for Food & Dietary Supplement Companies



I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN http://jifsan.umd.edu/) Food and Nutrition webinar.  The webinar covered topics including food labeling, infant formula, medical foods, color additives, partially hydrogenated oils and dietary supplements.  Most of the presenters that talked about labeling regulations focused on the proposed changes to the nutrition facts box, which we highlighted several months ago (http://tinyurl.com/me9rekg).  I want to share with you a few things I found interesting. 
I had heard some rumblings that the yet to be published final rule would very closely resemble the proposed rule and after listening to the FDA staff presentations, I expect that to be true.  As I read the proposed rule when it was first published I focused on the proposed changes and not FDA’s rationale for the various proposals.  The webinar presentations highlighted the rationale behind the proposals, convincing me that the agency is confident of the merits of the proposed rule and that much of it will remain intact in the final rule

For example, industry groups submitted comments on the proposed rule objecting to the proposal to declare total sugars and added sugars.  However, the proposal is rooted in the 2010 Dietary Guidelines for Americans that recommends reducing the intake of calories from solid fats and added sugars.  The presenter, Crystal R. Rivers of FDA’s Nutrition Programs in the Office of Nutrition, Labeling and Dietary Supplements, stated that on average, Americans get 16% of their total calories from added sugars and noted that labeling added sugars would encourage food manufacturers to reduce added sugars and help Americans to identify products with added sugars; compare products for amount of “added sugars” and reduce extra calories consumed by Americans.

Another speaker, Cherisa Henderson, Nutrition Programs Staff, Office of Nutrition, Labeling and Dietary Supplements, talked about the proposal for dual nutrition labeling that would list the calories
 and nutrients both a single serving and in the entire package for products that “can reasonably be consumed in a single-eating occasion”.   The proposal would mean that any product with 4 or fewer servings per container would list the nutrition facts per serving and for the whole container. Ms. Henderson presented findings from consumer studies that demonstrated that consumers were more aware of serving sizes and calories when both sets of information were presented.  FDA prides itself on being a science based organization and based on the data presented, I expect that FDA’s proposal to list the nutrition data for entire packages to be in the final rule.

The FDA presenters were repeatedly asked when various final rules on Food Safety Modernization and nutrition labeling would be published.  None of the speakers would venture a guess and one even said, "Hopefully in my lifetime."  We'll let you know as soon as we know.




Renew Food and Dietary Supplement Facilities Registration Now!
This was not mentioned in the recent webinar but it is time to renew ALL food facility registrations. This includes registrations of dietary supplement facilities.  All facilities must register between October 1st and December 31st of each even numbered year.  So, it is time for all food facilities both domestic and foreign to  re-register.  Online registration can be completed by following the login link on this page: http://tinyurl.com/kpb4nkj   To download forms for registration by mail, visit http://tinyurl.com/momm97g.

It is my hope that you will find these occasional updates helpful.  If so, you may subscribe to the email newsletter version by visiting http://eepurl.com/Imbjv  I 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. 

As always, my colleagues and I would be please to help you with product labeling, facility registration or other FDA compliance questions.  Contact us today by replying to this post.


All the best to you!
Evelyn & Associates


Monday, July 21, 2014

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 19th 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


Thursday, March 27, 2014

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