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FDA issued a draft guidance on liquid supplements in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.
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Evelyn & Associates
