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

Will December Bring New Proposals for the Dietary Supplement Industry?

Hello and Happy December!

FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods.  They also published updated guidance on cosmetic GMPs but have been relatively quiet about dietary supplements.  However, in September FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published their “Plan for Program Priorities, 2013-2014” that included quite a list of goals for the dietary supplement program (http://tinyurl.com/nx6hsse). Since there are less than 30 days left in 2013, it will be interesting to see whether FDA will publish a flurry of proposed rules or miss their proposed deadline.

CFSAN’s overall plan for the dietary supplement industry is to “take steps to improve the safety and labeling of dietary supplements and the supply chain.”  It is interesting that the supply chain was mentioned since many dietary supplement manufacturers have complained that the dietary supplement GMPs do not extend to the suppliers, making it difficult for manufacturers to convince raw material suppliers of the importance of good documentation and record keeping that would help manufacturers comply with the GMPs (http://tinyurl.com/lj3z35f).

The CFSAN Plan for Program Priorities goes on to list 5 planned steps to address the safety and labeling of dietary supplements:

     1.       Modernize the postmarket surveillance system for regulating dietary supplements. This was a recommendation from the Department of Health & Human Services Inspector General’s 2012 report, “Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements” (http://tinyurl.com/keq4b27). By the way, this document details a study in which the Inspector General’s Office reviewed label claims and the manufacturer’s substantiation dossiers for 72 dietary supplement products.

      2.       Develop and implement risk-based compliance and regulatory strategies to address dietary supplement safety issues.  FDA typically takes a risk-based approach in their oversight and regulatory enforcement actions in regulated industries.  In the past FDA had indicated that they were particularly interested in monitoring the marketplace for claims relating to cancer, diabetes and influenza H1N1; they also watch for supplements that claim to affect memory, sexual function and weight loss.  It is unclear whether FDA will publish their regulatory strategies but we will be watching for updates to their compliance policy and inspection manuals.

     3.      Publish revised draft guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements.  This highly anticipated guidance could prove to be very interesting.  The first draft was published in July of 2011.  FDA received over 12,000 comments on this document that appeared to the dietary supplement industry to be a substantial overreach by the agency that in effect, would put into place a premarket approval process for dietary supplements; a proposal that appears to violate the enabling legislation of the dietary supplement regulations.  It is unlikely that publication of the revised draft guidance would be received as good wishes for a prosperous new year by industry.

    4.      Publish final guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements.  While this step is set for 2014, the short timeline indicates that the agency does not expect as many comments as there were for the first draft.  Perhaps they have thoughtfully considered the industry’s previous comments and the document will be something that both industry and regulators will find workable.

    5.      Publish final guidance to help dietary supplement and beverage manufacturers and distributors determine whether a liquid food product (such as energy drinks) may be labeled and marketed as a dietary supplement.  In December of 2009 FDA published a guidance document on “Factors that Distinguish Liquid Dietary Supplements from Beverages…” (http://tinyurl.com/nxjuswg).  FDA issued the guidance at a time when many ‘functional beverages’ were making their way to store shelves.  The apparent aim was to rein in the industry; however the plethora of liquid products available that claim to be dietary supplements but look like beverages is testament to the fact that the 2009 guidance has been largely ignored.

If CFSAN does publish all those proposed documents, we will do our best to keep you up to date without inundating your inbox.  In the meantime, the associates at FDALabels.com and Bioscience Translation & Application are ready to help you ensure that your products are compliant with FDA regulations so that you can enjoy uninterrupted market success.

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

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