FDA allows KIND to use the phrase “Health and Tasty” – But NOT in its labels or labeling


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On March 17, 2015, the FDA issued a warning letter to KIND LLC, because the labels1 and labeling2 of KIND’s products bore a variety of nutrient content claims but the products did not meet the requirements to make such claims.  In particular, the FDA asserted that several of KIND’s products had an implied nutrient content claim, because they bore statements suggesting that the products may have been useful in maintaining healthy dietary practices, and those statements were made in connection with claims or statements about nutrients.  Specifically, the labels of the products bore the claim “Healthy and tasty, convenient and wholesome” in connection with statements such as:

  • “good source of fiber,”
  • “no trans fats,”
  • “very low sodium,”
  • “low sodium,”
  • “+ antioxidants,”
  • “+ protein,” and
  • “7g protein.”
Additionally, the FDA claimed that KIND’s website stated, “There’s healthy. There’s tasty. Then there’s healthy and tasty” and “all of our snacks are pretty much the nirvana of healthful tastiness.”  In addition, one product’s webpage stated that it was “a healthy and satisfying blend of peanuts and antioxidant-rich dark chocolate.  Each bar contains 7 grams of protein, which promotes satiety and strengthens bones, muscles and skin.”
The FDA concluded that none of the company’s products met the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2)3 below.

The FDA issued a closeout letter to KIND on April 20, 2016 after an evaluation of the corrective actions taken by the firm in response to the 2015 warning letter.  Some of KIND’s corrective actions included removing and amending certain nutrient content claims on product labels and labeling, as appropriate.  The FDA concluded that KIND satisfactorily addressed the violations contained in the warning letter.

Following receipt of the closeout letter, KIND requested confirmation that it could use the phrase “healthy and tasty” only in text clearly presented as its corporate philosophy, where it is not represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information.  In allowing KIND to use the phrase, the FDA wrote:

In our discussions with KIND, we understood the company’s position as wanting to use “healthy and tasty” as part of its corporate philosophy, as opposed to using “healthy” in the context of a nutrient content claim. The FDA evaluates the label as a whole and has indicated that in this instance it does not object.

The Take Aways

Be aware that the FDA’s food labeling regulations address the use of a number of adjectives and nouns, including:

  • Healthy
  • High Potency
  • Anti-oxidant
  • Sugar Free
  • High, Rich In, or Excellent Source Of
  • Good Source, Contains, or Provides
  • More, Less, Fewer
  • Lean or Extra Lean
  • Modified
  • Light
  • Reduced, Added, Extra, Plus, Fortified, or Enriched

Such  adjectives or nouns may only be used in connection with a food or dietary supplements if it meets the requirements of the application labeling regulation.

_________________________________

1A “label” is defined as:

a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

Section 201(k) of the Food, Drug and Cosmetic Act.

2The term “labeling” is defined as:

all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

Section 201(m) of the Food, Drug and Cosmetic Act.

“Labeling” includes labels, inserts, flyers, display packs, leaflets, promotional literature, advertising, or any other written or printed information associated with a product.

321 CFR § 101.65 (Implied nutrient content claims and related label statements) provides:

(d) General nutritional claims.

*   *   *

(2) You may use the term ‘‘healthy’’ or related terms (e.g., ‘‘health,’’ ‘‘healthful,’’ ‘‘healthfully,’’ ‘‘healthfulness,’’ ‘‘healthier,’’ ‘‘healthiest,’’ ‘‘healthily,’’ and ‘‘healthiness’’) as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if:

(i) The food meets the following conditions for fat, saturated fat, cholesterol,
and other nutrients:

If the food is The fat level must
be
The saturated fat
level must be
The cholesterol level
must be
The food must contain
(A) A raw fruit or vegetable Low fat as defined
in § 101.62(b)(2)
Low saturated fat as
defined in
§ 101.62(c)(2)
The disclosure level
for cholesterol
specified in
§ 101.13(h) or less
N/A
(B) A single-ingredient or a mixture
of frozen or canned fruits
and vegetablesa
Low fat as defined
in § 101.62(b)(2)
Low saturated fat as
defined in
§ 101.62(c)(2)
The disclosure level
for cholesterol
specified in
§ 101.13(h) or less
N/A
(C) An enriched cereal-grain
product that conforms to a
standard of identity in part 136,
137 or 139 of this chapter
Low fat as defined
in § 101.62(b)(2)
Low saturated fat as
defined in
§ 101.62(c)(2)
The disclosure level
for cholesterol
specified in
§ 101.13(h) or less
N/A
(D) A raw, single-ingredient seafood
or game meat
Less than 5 grams
(g) total fat per
RAb and per 100
g
Less than 2 g saturated
fat per RA
and per 100 g
Less than 95 mg
cholesterol per RA
and per 100 g
At least 10 percent
of the RDIc or the
DRVd per RA of
one or more of vitamin
A, vitamin
C, calcium, iron,
protein, or fiber
(E) A meal product as defined in
§ 101.13(l) or a main dish product
as defined in § 101.13(m)
Low fat as defined
in § 101.62(b)(3)
Low saturated fat as
defined in
§ 101.62(c)(3)
90 mg or less cholesterol
per LSe
At least 10 percent
of the RDI or DRV
per LS of two nutrients
(for a main
dish product) or of
three nutrients (for
a meal product)
of: vitamin A, vitamin
C, calcium,
iron, protein, or
fiber
(F) A food not specifically listed in
this table
Low fat as defined
in § 101.62(b)(2)
Low saturated fat as
defined in
§ 101.62(c)(2)
The disclosure level
for cholesterol
specified in
§ 101.13(h) or less
At least 10 percent
of the RDI or the
DRV per RA of
one or more of vitamin
A, vitamin
C, calcium, iron,
protein or fiber

a May include ingredients whose addition does not change the nutrient profile of the fruit or vegetable.
b RA means Reference Amount Customarily Consumed per Eating Occasion (§ 101.12(b)).
c RDI means Reference Daily Intake (§ 101.9(c)(8)(iv)).
d DRV means Daily Reference Value (§ 101.9(c)(9)).
e LS means Labeled Serving, i.e., the serving size that is specified in the nutrition information on the product label (§ 101.9(b)).

(ii) The food meets the following conditions for sodium:

If the food is The sodium level must be
(A) A food with a RA that is
greater than 30 g or 2 tablespoons
(tbsp.)
480 mg or less sodium per
RA and per LS
(B) A food with a RA that is
equal to or less than 30 g
or 2 tbsp.
480 mg or less sodium per
50 ga
(C) A meal product as defined
in § 101.13(l) or a main dish
product as defined in
§ 101.13(m)
600 mg or less sodium per
LS

a For dehydrated food that is typically reconstituted with water or a liquid that contains insignificant amounts per RA of all nutrients (as defined in § 101.9(f)(1)), the 50 g refers to the ‘‘prepared’’ form of the product.

(iii) The food complies with the definition and declaration requirements in this part 101 for any specific nutrient content claim on the label or in labeling, and

(iv) If you add a nutrient to the food specified in paragraphs (d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 10 percent requirement, that addition must be in accordance with the fortification policy for foodsin § 104.20 of this chapter.

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