The agency has avoided the issue for years but on November
12, 2015 the FDA published a “Request for Information and Comments” on the use
of the term “Natural” in the labeling of human food products (
http://tinyurl.com/ngvxw9a).
Note that the general term "food" includes
dietary supplements. While cosmetics and pet foods are not part of this
request for comments, it is highly likely that any definition of “natural” for
use in food labeling will influence the labeling of other FDA-regulated
products.
The Federal Register Notice provides a brief history of FDA’s
stance on the term “natural” and lists a number of questions the agency would like
respondents to the request for information and comments to answer. From the
brief history: Three Federal district courts hearing cases on natural labeling for
foods containing genetically engineered ingredients and a fourth with a case on
natural labeling for high fructose corn syrup have made referrals or requests to
FDA for a definition of natural. There have also been several citizen petitions
regarding use of the term “natural” in food labeling, including one from
Consumers Union that asked the agency to prohibit the use of the term “natural”
in food labeling since consumer expectations of the meaning of the term differs
so much from how the term is used in the marketplace.
Previously FDA regulations have only defined natural in
terms of colors and flavors (21 CFR 101.22). The agency considers any added color to be artificial even if derived from fruits,
vegetables or other natural sources.
(Compare to dyeing hair with henna—even though henna is a plant extract,
it still alters the hair’s natural color.)
According to FDA, natural flavors are substances used to
impart flavor that are derived from a spice, fruit or fruit juice, vegetable or
vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant
material, meat, fish, poultry, eggs, dairy products, or fermentation products
thereof.
[Note that FDA provides this definition
in a backhanded way since 21 CFR 101.22 actually only defines artificial
flavors as “any substance, the function of which is to impart flavor, which is
not derived from a spice, fruit or fruit juice, vegetable or vegetable juice,
edible yeast, herb, bark, bud, root, leaf or similar plant material, meat,
fish, poultry, eggs, dairy products, or fermentation products thereof.” The
definition of artificial flavor also includes any lab synthesized versions of
flavor molecules. It is interesting to
note that European countries allow use of the term ‘natural identical’ for
lab-synthesized flavors but FDA deems them artificial.]
The USDA Food Safety and Inspection Service (FSIS), which
oversees the labeling of foods containing meat and poultry, defines a natural
food as one that “contains no artificial ingredients and is only minimally
processed.”
The FSIS’s Food Standards
and Labeling Policy book (see link on this page:
http://tinyurl.com/nqbbutn)
provides details on the meaning of ‘artificial’ and minimally processed:
(1) the product does not contain
any artificial flavor or flavoring, coloring ingredient, or chemical
preservative (as defined in 21 CFR 101.22), or any other artificial or
synthetic ingredient; and (2) the product and its ingredients are not more than
minimally processed. Minimal processing may include: (a) those traditional
processes used to make food edible or to preserve it or to make it safe for
human consumption, e.g., smoking, roasting, freezing, drying, and fermenting,
or (b) those physical processes which do not fundamentally alter the raw
product and/or which only separate a whole, intact food into component parts,
e.g., grinding meat, separating eggs into albumen and yolk, and pressing fruits
to produce juices.
As a matter of policy FDA has stated that they consider natural
to mean, “that nothing artificial or synthetic (including colors regardless of
source) is included in, or has been added to, the product that would not normally
be expected to be there.”
This policy
comes from FDA’s 1991 proposed rule for nutrient content claims in which the
agency also proposed defining fresh and natural.
http://tinyurl.com/odllnwj
While the agency did define fresh (21CFR101.95)
they were unable to define “natural” because, “none of the comments provided
FDA with a specific direction to follow for developing a definition regarding
the use of the term ‘natural.’ Clearly
it is up to concerned citizens, including industry and anyone who eats to help
FDA arrive at a meaningful definition of “natural”,
The recent request for comments includes a long list of
questions FDA has on the topic including, whether the food preparation or manufacturing
processes should be considered; whether agricultural practices should be
considered and whether genetically engineered foods should be allowed to be
labeled as natural. (Scroll down to see FDA’s full list of questions.)
You may submit comments on “natural” labeling by visiting
http://tinyurl.com/qdqr9b9).
Or if you prefer, send us your comments and we will collate them into a
submission to FDA.
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Here are the questions FDA is seeking input on as they develop
a definition for natural in food labeling. (You do not have to address all of
the questions in your comments.)
:
• Should we define, through rulemaking, the term
‘‘natural?’’ Why or why not?
• Should we prohibit the term ‘‘natural’’ in food labeling?
Why or why not?
• If we define the term ‘‘natural,’’ what types of food
should be allowed to bear the term ‘‘natural?’’
• Should only raw agricultural commodities be able to bear
the term? Why or why not? Section 201(r) of the FD&C Act defines the term
‘‘raw agricultural commodity’’ as ‘‘any food in its raw or natural state,
including all fruits that are washed, colored, or otherwise treated in their
unpeeled natural form prior to marketing.’’
• Should only single ingredient foods, e.g., bottled water
or bagged spinach, be able to bear the term? Why or why not?
• If multi-ingredient foods should be able to bear the term,
what type(s) of ingredients would disqualify the food from bearing the term?
Please explain why such disqualification would be warranted.
• We are interested in any data or other information to suggest
that consumers associate, confuse, or compare the term ‘‘natural’’ with ‘‘organic’’
(the USDA Agricultural Marketing Service administers the National Organic
Program, which enforces laws and regulations regarding certified organic
foods). We are interested in data and other information about consumers’
understanding of foods labeled ‘‘natural’’ versus ‘‘organic.’’ Is the term
‘‘natural’’ on food labels perceived by consumers the same way as ‘‘organic?’’
Or is ‘‘natural’’ perceived by consumers to be ‘‘better’’ (or not as good as)
‘‘organic?’’ Please provide consumer research or other evidence to support your
comment.
• If we were to revise our policy regarding the use of the
term ‘‘natural’’ or engage in rulemaking to establish a regulatory definition
for ‘‘natural,’’ should certain production practices used in agriculture, for
example, genetic engineering, mutagenesis, hybridization, the use of
pesticides, or animal husbandry practices, be a factor in defining ‘‘natural?’’
Why or why not?
• We are interested in any data or other information to
suggest that consumers associate, confuse, or compare the term ‘‘natural’’ with
‘‘healthy.’’ We have a regulation that defines the term ‘‘healthy’’ when used as
an implied nutrient content claim with specific conditions related to the food’s
nutrient profile that must be met in order to use the term on the label or in
labeling of a food (see § 101.65(d)). We are interested in data and other information
about consumers’ understanding of foods labeled ‘‘natural’’ versus ‘‘healthy.’’
Is the term ‘‘natural’’ on food labels perceived by consumers the same way as
‘‘healthy?’’ Or is ‘‘natural’’ perceived by consumers to be ‘‘better’’ (or not
as good as) ‘‘healthy?’’ Do consumers view ‘‘natural’’ and ‘‘healthy’’ as
synonymous terms? Please provide consumer research or other evidence to support
your comment.
• Should manufacturing processes be considered in
determining when a food can bear the term ‘‘natural?’’ For example, should food
manufacturing processes, such as drying, salting, marinating, curing, freezing,
canning, fermenting, pasteurizing, irradiating, or hydrolysis, be a factor in
defining ‘‘natural?’’
• Should the term ‘‘natural’’ only apply to ‘‘unprocessed’’
foods? If so, how should ‘‘unprocessed’’ and ‘‘processed’’ be defined for
purposes of bearing the claim? If the term natural should include some
processing methods, what should those methods be? In making determinations
related to processing, should one look at the process to make a single
ingredient of a food, or does one evaluate the process done to the formulated
finished food product (or both)?
• The current policy regarding use of the term ‘‘natural’’
hinges in part on the presence or absence of synthetic ingredients. For
example, under the current policy synthetic forms of Vitamin D would not be
used in a food claiming to be ‘‘natural,’’ whereas naturally sourced Vitamin D
(e.g., from salmon or egg yolks) could be. Should the manner in which an
ingredient is produced or sourced affect whether a food containing that
ingredient may be labeled as ‘‘natural?’’ Please explain your reasoning.
• What can be done to ensure that consumers have a
consistent and accurate understanding of the term ‘‘natural’’ in food labeling
to ensure that it is not misleading?
• What are the public health benefits, if any, of defining
the term ‘‘natural’’ in food labeling? Please provide supporting data and other
information to support your comment.
• Should ‘‘natural’’ have some nutritional benefit
associated with it? If so, what should be the benefit? What nutrients should be
considered? What data are available to support the association between
‘‘natural’’ and a given nutritional benefit, and/or between ‘‘natural’’ and
certain nutrients?
• How might we determine whether foods labeled ‘‘natural’’
comply with any criteria for bearing the claim?
