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

FDA's New View of Partially Hydrogenated Oils

On November 7, 2013 FDA published a ‘Request for Comments and for Scientific Data and Information’ regarding the use of partially hydrogenated oils in foods.  The FDA has reviewed the scientific data and has determined that there is no longer scientific consensus on the safety of partially hydrogenated oils due to the presence of artificial trans fats in those oils.  (Note that fully hydrogenated oils do not contain trans fats.)  Since there is not a consensus on the safety of partially hydrogenated oils, FDA is poised to declare that these oils as no longer generally regarded as safe (GRAS).  Once the GRAS status is so rescinded, partially hydrogenated oils would not be allowed in food products sold in the US.  

Partially hydrogenated oils were invented in the 1930’s and have been considered GRAS since they were in common use prior to the 1958 Food Additives Amendment to the FD&C Act.  It was even thought that partially hydrogenated vegetable oils were ‘healthier’ than dairy and other animal fats that they replaced in many products; particularly baked goods.

Oils are partially hydrogenated to increase their solidity and melting temperature and to increase the shelf life of the products they are used in.  These effects are all gained when the double bonds in unsaturated vegetable oils are converted into single bonds by the addition of hydrogen.  Partially hydrogenated oils can result in some trans fat bond conformations that are not readily broken down by the body’s enzymes, leading to build up of these fats in the body. 

When FDA began requiring that the amounts of trans fatty acids be declared in the nutrition facts panel in 2006, many food products were reformulated just enough to bring trans fat levels below the 0.5 gram threshold of declaration.  Many consumer groups were outraged that 0.499 grams of trans fat were required by regulation to be declared as 0 grams of trans fat and FDA has been pressured to take further steps since then.  A suit was filed in California seeking to force FDA to take steps to remove trans fat from the US food supply. 

Most of our clients don’t use trans fatty acids. However, in the course of our detailed label and ingredient reviews, we have sometimes found that ingredient suppliers were not being entirely upfront with their customers.  Some only provide nutritional information on a very small amount of their fats and oils. In doing so, they can list trans fats as zero. So what is a food-producer to do? 

      1.      Understand that it is only artificial trans fats that are harmful and they come from partially hydrogenated oils.

      2.      Always, always, ask for detailed specifications and certificates of analysis for every ingredient in your product.

      3.      Read the specifications and certificates of analysis and ask questions about anything you do not understand.

      4.      Write detailed specifications for your product that ensure that only the quality of ingredient you want is used in your product so that it will not trans fats or any other ingredient/component your customers may wish to avoid.

You can read more about FDA’s proposal to rescind the GRAS status of partially hydrogenated oils.  This link will take you to a summary aimed at consumers: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm373925.htm .  This link will take you to the full announcement in the Federal Register: http://www.gpo.gov/fdsys/pkg/FR-2013-11-08/pdf/2013-26854.pdf.

As always, please post a comment to this blog with your questions on labeling and other FDA regulations.

Regards,

Evelyn & Colleagues
FDALabels.com                                      www.FDALbels.com
Bioscience Translation & Application    www.BioTransApp.com

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.

Nutrition Labeling of Major Cuts of Meat Required by January 2012

Hello!

I know the name of this blog is FDA Update but my team provides USDA regulatory help from time to time and that agency has caught my attention today.    My favorite blog, FDA Law Blog by Hyman Phelps & McNamara posted about the new USDA requirement for nutrition labeling on major cuts of meat here: FDA Law Blog USDA Nutrition Labeling.  It got me wondering what my local, independent butcher was doing to comply, so I called him and initially ruined his day.  I felt so bad!  I ended up researching the rule more thoroughly and found that USDA's Food Safety and Information Service (FSIS) has prepared posters that butcher and other meat retailers can print and display to comply with the labeling rule. I called my butcher back and told him the good news sent him the posters.  So, here for your convenience are links to the FSIS nutrition labeling posters: Beef & Veal, Chicken & Turkey and Pork & Lamb.  The posters are high resolution PDFs that can be enlarged as needed.  I suggest that butchers and other small business meat retailers go to their local print shop and get large laminated versions that can be displayed in the shop.  

There are other requirements for posting nutrition information for ground products.  Many small business owners are exempt but consumers may seek the information. For a list of other information on this new rule visit the this page at the FSIS website. 


You can also visit the Bioscience Translation & Application  website atwww.BioTransApp.com.

FDA Draft Guidance on New Dietary Ingredient Notifications

Hello!

Summer is in full swing here in the Northern Hemisphere and FDA is heating things up for the US dietary supplement industry.  On Friday, July 1, 2011 FDA published the long-anticipated Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications. You can read the whole guidance at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm.  The issuance of this guidance was mandated by the Food Safety Modernization Act signed into law in January of this year. The goal is to clarify when a New Dietary Ingredient Notification should be submitted.  New Dietary Ingredients are substances intended for use in dietary supplement products which both meet the definition of ‘dietary ingredient’ and which were not marketed as dietary ingredients prior to October 15, 1994, the day that the Dietary Supplement Health Education Act became law.

Our team routinely checks ingredients in dietary supplement products we review for their regulatory status and we also work on New Dietary Ingredient Notifications. As the lead consultant for our group, I work hard at keeping up with FDA guidance documents and warning letters. Nevertheless, I was surprised and even shocked by some of the things I found in the guidance upon first reading today and thought you might be interested in them also.

Dietary supplements are regulated as a special class of foods in the US and prior to issuance of this guidance, my team and I understood that conventional food ingredients that met the definition of dietary ingredients and that were not chemically altered were not new dietary ingredients and would not require a notification (NDIN).  According to the guidance, there are circumstances in which an NDIN would not be required BUT the product could be considered adulterated under certain circumstances if no NDIN has been filed.  Frankly, I need to read these sections a few more times and probably draw a diagram to figure these details out because the various exceptions are confusing. 

It has been common practice for dietary supplement manufacturers to rely on NDINs made by other companies, trusting that once an NDIN had been filed and FDA had no objections, anyone could market the ingredient. However, the NDIN draft guidance makes it clear that EVERY manufacturer must submit an NDIN if they plan to market a dietary ingredient that was not marketed prior to October 15, 1994.  This interpretation, once enforced, could readily result in branding two thirds of the dietary supplements currently on the market as adulterated. Clearly, companies and consultants will be very busy filing NDINs for ingredients and products that have been sold for years.

This next issue that got my attention was not really surprising, since FDA has been applying this standard to recent NDINs, but still breathtaking to see spelled out: The draft guidance unequivocally states that synthetic versions of naturally occurring substances ARE NOT dietary ingredients unless they were marketed as dietary supplements prior to October 15, 1994.  Most vitamins are safe since synthetic versions were used prior to that date but what about indol-3-carbinol, limonene, resveratrol, various isoflavones and countless other phytochemicals that are valuable for maintaining health but occur in amounts too small to make extraction with water and ethanol feasible and affordable. (Note that water and ethanol were the only solvents the guidance listed as not chemically modifying an ingredient.)  Seems that ingredient manufacturers need to hustle and see if they have sufficient data to obtain GRAS status for use of their ingredients in dietary supplements. 

Similarly, naturally-occurring metabolites and other biochemicals that have been stabilized by adding esters or other chemical moieties are not considered dietary ingredients.  It is clear from the guidance document that FDA has reviewed some supplements that are on the market and determined that they have been “chemically altered” and do not meet the criteria to be sold as dietary ingredients. One example of this is high selenium yeast.  The guidance states that chemical alteration includes, “Changing agricultural or fermentation conditions to alter the chemical composition of the ingredient, such as by sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.” It also appears that FDA would consider some probiotics as chemically altered by “use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese.”

The draft guidance on New Dietary Ingredient Notifications will undoubtedly have a tremendous impact on the US dietary supplement industry. We will continue to review the guidance and provide you with insights in the coming weeks.  In the meantime, contact us with questions regarding New Dietary Ingredient Notifications (NDINs); Generally Regarded As Safe (GRAS) designation or your other regulatory affairs needs.

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Sincerely,

Evelyn and Team

Bioscience Translation & Application

Liquid and Semi-solid Foods and Dietary Supplements

On March 3, 2011 FDA published a final rule that amended 21CFR 113, which regulates ‘thermally processed low acid canned foods in hermetically sealed containers” to allow the use of ‘temperature indicator devices’ other than mercury filled glass thermometers.  So why am I telling you about this?  Partly because what the agency calls ‘canned foods’, which brings to mind metal containers and possibly glass jars, also refers to other aseptically processed foods and beverages. But I tell you about this mostly because this modernization from mercury filled glass thermometers is not the agency’s only recent alertness to this general sector of regulations. You see, the sister regulations for ‘thermally processed low acid canned foods’ are regulations covering the production of ‘acidified foods’-- foods which are not aseptically processed because their pH is low enough to prevent spoilage.

So what?  Well, you and I and FDA have noticed many more liquid dietary supplements in the marketplace.  Most contain acid ingredients and therefore are acidified foods. However, not all manufacturers comply with the regulations of 21CFR114, which require that they register their facilities as acid food producers and file the processes by which they assure that the product will not spoil and cause public harm. This registration is separate from the more generic food facility registration. I wrote about this once before in November of 2010 but I am raising the issue again because I continue to see liquid dietary supplements that have acidic components added to them but whose processes have not be filed with FDA.  Because this regulation is important for ensuring the safety of public health, any violation could cause your company to have to cease production until FDA approves your process and your entire Good Manufacturing Practices (GMP) program. 

I am also concerned about these sister regulations because I have seen a number of liquid ‘alkalinizing’ products on the market—they too would fall under one of these sets of regulations.  The guidance documents for these regulations are really hard to find on the FDA website and an FDA staffer in the office of Low Acid Canned Foods agreed that the regulations are difficult to understand; none the less, if you are producing a liquid or semi-solid product that is preserved in any way, you probably need to pay attention to this. 

If you have any doubt about which regulations apply to your products, contact us by leaving a comment. We are here help.

If you know what regulations apply to your product but need help complying with them—let us know.