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

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

Does your Contract Manufacturer Comply with cGMPS?

Hello!

I hope that your business is doing well enough to allow you to relax a bit as summer starts.  Knowing that your contract manufacturer complies with FDA’s current Good Manufacturing Practices (cGMPs) can reduce stress a bit. But how do you know that their cGMPs are up to snuff?  Many of you will recall conversations we’ve had about ingredient specifications and certificates of analysis. Well, today I saw a well-written article on this topic in Natural Products Insider by Kevin Cloud, senior method development chemist in the Capsugel Licaps® laboratory.  You may read the article below or link to it here: http://www.naturalproductsinsider.com/articles/2011/06/inquire-about-incoming-ingredient-inspection.aspx

FDA continues to inspect dietary supplement manufacturers and to write warning letters detailing a wide variety of GMP violations. Responding to such letters and correcting the violations can mean that your manufacturer may not be able to fulfill your next order on time or worse, that your product will have to be recalled and possibly destroyed if not produced under cGMPs.  Something like that would certainly ruin your summer.

Avoid future problems by thoroughly investigating your manufacturer and suppliers and be aware of the GMPs that you as the distributor must have in place.  The team at Bioscience Translation & Application wants to help you succeed.  Contact us for help with labels, GMPs or your questions about FDA regulations and processes.

Happy Summer!

Evelyn & Associates

Bioscience Translation & Application

Inquire About Incoming Ingredient Inspection

By Kevin Cloud

Natural Products Insider

June 17, 2011

 Dietary supplement cGMPs (current good manufacturing practices) establish minimum practices necessary for activities related to manufacturing, packaging, labeling and holding dietary supplements to ensure product quality. The final product owner is ultimately responsible for the dietary supplement that is released to the market, and each company in the supply chain contracted by the final product owner is responsible for ensuring its activities comply with cGMPs. Final product owners should make sure contract manufacturers have the resources, processes and commitment to comply with the cGMPs.

One important part of the equation for manufacturers is to ensure the integrity and quality of the raw materials purchased for production of finished goods. Federal regulations require manufacturers establish raw material specifications covering identity, purity, strength, composition and limits on contamination before placing an order.

How can the final product owner ensure these specifications are met? By asking three simple questions related to ingredient identification, and getting the answers related to testing, equipment and results in writing.

Question 1: Can I see the raw material specifications for raw material X that will be included in my product?

The contract manufacturer should provide a copy of a specification with all of the testing that is expected to be performed plus the criteria for passing or failing the raw material. Following are examples of mandatory specification parameters and what information they provide:

• Identity: What is the substance? Is it the ingredient as desired, to ensure the integrity of the product as labeled? Or is it a mixture or even perhaps an entirely different substance altogether?
• Assay: Determines the strength or potency of a substance.

Contamination: Determines unwanted substances in the raw material, such as heavy metals, pesticides and residual solvents, and any allowable limits.

Question 2: What instruments does your facility use to identify the incoming raw material X and can I see the qualification package for at least one of these instruments?

The manufacturer should have the ability to provide copies of the qualifications for each instrument listed. A qualification is made up of three distinct parts: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The qualification package is usually purchased at the time the instrument is installed or moved. The qualification is performed by a certified technician from the manufacturer of the equipment.

Typical laboratory instruments used for testing include high performance liquid chromatography (HPLC); gas chromatography (GC); ultraviolet visible spectroscopy (UV/Vis); fourier transform infrared spectroscopy (FTIR); high performance thin layer chromatography (HPTLC); melting point (MP); microscope; and near infrared spectroscopy (NearIR).

Question 3: What types of methods are you using to assay incoming raw material X and can I see a validation/verification summary and standard operating procedure (SOP) for that raw material?

From the list of instruments above, HPLC is the workhorse of the nutrition industry for analyzing potency or strength of a substance. But HPLC is only a piece of equipment. A method, or set of directions, is also essential to assay a sample; it is like a road map for the HPLC.

Whatever method or direction is used—and there are many from a wide variety of sources—it should be scientifically valid. Some recognized scientific compilations of methods are the U.S. Pharmacopeia (USP), American Oil Chemist Society (AOCS), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP). Methods are often put into a company’s particular format, such as a SOP, a standard operating instruction (SOI) or a work instruction (WI).

Remember the final product owner is ultimately responsible for the dietary supplement released to the market, and that responsibility includes ensuring the product is manufactured, packaged, labeled and held according to dietary supplement cGMPs. Asking some basic questions related to ingredient qualification can provide helpful information, realizing a manufacturer that is missing any of the three major components—raw material specs, qualified instruments or written procedures—is not compliant with cGMPs.

Evelyn Cadman

Principal Consultant

Medical Device Import Entry Review Process

Hello!

The device industry in the US continues to wonder what will become of the 510(k) process.  Senator John Kerry of Massachusetts has written a letter to FDA Commissioner Dr. Margaret Hamburg raising concerns that the medical device industry has over potential changes to the 510(k) process.  You can read more about his letter here: http://tinurl.com/3wyoqsw

FDA raised more concerns and sowed seeds of confusion in the medical device industry by publishing a letter about the import entry review process. (see http://tinyurl.com/4rqlg3r)  I too was confused and so contacted the Center for Device and Radiologic Health (CDRH) for clarification.  Turns out there is nothing new about the process and all that CDRH wanted to say is that imported devices can clear FDA’s border inspections faster if the paperwork includes the A of C code for the medical device being imported.

When importing a medical device into the US, the accompanying entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. When importing devices you must provide the following information:

1. Foreign manufacturer number (obtained from FDA when the manufacturer registers with FDA)
2. Listing information (Listing of the devices the company manufactures—this is done in conjunction with the registration process.)
3. Identity of the initial importer
4. The 510(k) or PMA number for the device

All of this information is communicated by the A of C codes and FDA’s March letter was simply trying to convey that the AofC codes are very helpful to the agency—so what is an AofC code?

AofC stands for ‘Affirmation of Compliance’.  Use of the code conveys the information listed in 1-4 above but goes further—the importer is pledging, affirming, swearing, that the product meets all FDA requirements specific to each code. So the good news is that you may be able to expedite entry of your devices into the US.  The bad news is that there are some devices that do not have AofC codes.  The codes can be found at the end of FDA’s letter.

My associates and I hope that your product is successful whether you are importing your device or manufacturing it in the US.  Contact us with your regulatory needs be it registration, listing or 510(k) or PMA submissions.

Learn more about the services we offer at www.BioTransApp.com.

Regards,

Evelyn