Recent FDA Guidance on Beverages, Liquid Supplements & Their Ingredients

In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages (http://tinyurl.com/m443cla) and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (http://tinyurl.com/nhwqz26).  I will discuss the guidances in detail below but will start with the parts that are particularly interesting:

First, in addition to outlining the attributes that FDA will consider when determining whether a product is classified as a beverage or a liquid dietary supplement, the guidance on distinguishing beverages and dietary supplements also provides some interesting comments on the types of claims that may be used on beverage labels. The guidance notes that in addition to authorized health and nutrient content claims, certain structure function claims may also be made about conventional beverages.  However, FDA reminds the reader that structure function claims on foods and beverages are only permissible when the claimed effect derives from “the product’s character as a food—its taste, aroma or nutritive value.” The document goes on to state that if the structure function claim promotes the product for another use that may involve a physiological effect, then the product may be considered a drug.  This is not a new provision.  Past conversations I have had with current and former FDA staff members indicated that “nutritive value” refers to conventional nutrients such as carbohydrates, fat, protein, fiber, vitamins and minerals. This makes me wonder whether this guidance indicates that FDA objects to claims about gut health and digestive regularity as seen on some yogurt and fermented beverage products.  

FDA issued a draft guidance on liquid supplements in December of 2009.  The 2014 final guidance issued this week is not significantly different from the 2009 draft but does provide some additional detail and clarifying examples.  So how are liquid supplements and beverages differentiated?  The new guidance lists the following criteria to consider when determining the classification of a liquid product for ingestion:

1.    Product labeling and advertising.  If the product is promoted to “refresh” or “rehydrate”, then it is a beverage even if its label includes a supplement facts box.

2.      Product names.  If the product name includes terms such as “beverage”, “drink”, “water” or “soda”, the product is a beverage, not a dietary supplement.  FDA notes that the term “tea” is not used exclusively for beverages; implying that some teas may be dietary supplements but the other criteria must also be considered.

3.      Product packaging size, shape, color, design, whether it is recloseable and the volume it holds is a factor to be considered in classifying a product as a beverage or liquid supplement.

4.      Serving size and recommended intake.  The guidance states that Americans consume about 1.2 liters of water and other beverages daily.  If the serving size of a liquid product makes up a significant portion of 1.2 liters, then the product would be considered a beverage and not a liquid dietary supplement.

5.      Recommendations and directions for use. If a product is recommended to quench thirst, it would be a beverage.  If the directions were similar to ‘take one tablespoon three times per day, it is probably a dietary supplement.

6.      Marketing practices. Advertising that compare the product to other beverages or suggest that it can substitute for a beverage or if metatags are used that bring the product up in searches for beverages, then the product is a beverage and not a dietary supplement.

7.      Composition.  FDA noted that simply adding a dietary ingredient that is only permitted in dietary supplement products to a conventional food does not transform that food into a dietary supplement.  The agency gives the example that adding ginkgo to a conventional beverage does not cause that product to be classified as a dietary supplement.

8.      Other information including information found in patents or filings with the Security and Exchange Commission.

The guidance also states that powders and premixes can be either for beverage or dietary supplement purposes.  It is also important to note that the guidance discusses the fact that food ingredients must be either GRAS (generally recognized as safe) or approved food additives. GRAS ingredients and approved food additives may typically be used in dietary supplements.  However, the caveat is added that these GRAS ingredients and approved additives must be used in accordance with the regulations that stipulate the approved amounts and uses, a condition which is frequently ignored. 

The discussion of GRAS ingredients, approved food additives and dietary ingredients echoes the second guidance document that FDA published on January 13, 2014.  FDA’s purpose in issuing this guidance is “to remind manufacturers and distributors of conventional foods about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional foods, including beverages.” The guidance states in part,

“We are concerned that some of the novel substances that are being added to conventional foods, including beverages, may cause the food to be adulterated because these added substances may not be GRAS for their intended use and are not being used in accordance with a food additive regulation prescribing conditions of safe use. In addition, some substances that have been present in the food supply for many years are now being added to conventional foods at levels in excess of their traditional use levels or in new types of conventional foods. This trend raises questions as to whether these higher levels and other new conditions of use are safe.”

My interpretation of this is that FDA is eyeing the growing use of caffeine in a variety of products.  The regulation on the use of caffeine (21 CFR 182.1180) states,

(a) Product. caffeine.

(b) Tolerance. 0.02 percent.

(c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice.

Clearly there are many products caffeine-containing products on store shelves today are not cola beverages and many contain much more than 0.02% caffeine. 

Similarly there are regulations regarding the fortification of foods and beverages with vitamins (21 CFR 104.20).  This guidance may well serve to remind manufacturers of vitamin-containing drinks and other functional foods and beverages of the restrictions on adding vitamins to those products.

This guidance also notes that binders, excipients and fillers used in dietary supplements must conform to the approved uses for additives or be used in accordance with their GRAS intended uses. 

While FDA states in both of these guidances that they “do not establish legally enforceable responsibilities” I read both guidances as a heads up to industry to review the regulations covering the ingredients used in their products and also to review the classification of any liquid products offered for sale.

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

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.

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