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FDA issued a draft guidance on liquid supplements in December of 2009.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

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

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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