## Chocolate Manufacturers Association • National Confectioners Association

### 7900 Westpark Drive, Suite A-320, McLean, Virginia 22102-4203

Telephone: 703/790-5011 **•** Telephone: 703/790-5750

FAX: 703/790-5752

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January 8, 2003

Dockets Management Branch

(HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: [Docket No. 02P-0462]{.underline}

Dear Sir or Madam:

The Chocolate Manufacturers Association (CMA) and the National
Confectioners Association (NCA) appreciate this opportunity to comment
on the petition by Carbolite® Foods, Inc. to use an implied nutrient
content claim in its brand name. CMA and NCA strongly oppose this
petition and urge the Food and Drug Administration (FDA) to deny it.

CMA is the national not-for-profit association representing the majority
of chocolate manufacturers in the United States. CMA members produce
over 90 percent of all chocolate manufactured in this country. In
addition to supplying the trade with bulk chocolate products, CMA
members also manufacture and market a wide variety of finished chocolate
and chocolate-containing products for the consumer market. NCA is the
national not-for-profit association representing more than 650
confectionery manufacturers and suppliers.

CMA and NCA believe that "Carbolite" does not meet the statutory
criteria for approval of an implied nutrient content claim in a brand
name. We believe there is a fundamental disconnect between the proposed
nutrient content claim, "Carbolite," and the nutritional criteria
proposed for allowance of the claim, "zero sugar" or "reduced sugar."
Finally, we believe it would be bad public policy for FDA to alter its
long-standing policy, which does not allow nutrient content claims about
a food's total carbohydrate content.

1.  **"Carbolite" Does Not Satisfy the Statutory Criteria for an Implied
    Nutrient Content Claim in a Brand Name.**

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA must
grant a petition for permission to use an implied nutrient content claim
in a brand name if FDA finds that such claim is: (i) not misleading, and
(ii) consistent with the nutrient content claims defined in FDA
regulations. 21 U.S.C. § 343(r)(4)(A)(iii). The nutrient content claim
"Carbolite" proposed by this petition meets neither of the two statutory
criteria for approval. It is clearly inconsistent with existing defined
nutrient content claims, and it is inherently misleading to consumers.

a.  **"Carbolite" is Inconsistent with FDA's Defined Nutrient Content
    Claims.**

Despite the petitioner's logical contortions, the proposed nutrient
content claim "Carbolite" is plainly not consistent with existing FDA
defined nutrient content claims. While the term "Carbolite" is a novel
term, its meaning is clear. "Carbolite" means that a food is low in
total carbohydrates. A "low in total carbohydrates" nutrient content
claim is clearly inconsistent with existing nutrient content claim
regulations.

As the petitioner notes, FDA specifically declined to authorize any
nutrient content claims for total carbohydrates.[^1] In fact, the
petition admits, in so many words, that "Carbolite" is not consistent
with the existing regulatory scheme for nutrient content claims.
According to the petitioner, "while current FDA policy recognizes that
'fermentable carbohydrates' (*i.e.,* *net effective carbs*) constitute a
class of carbohydrates that are metabolically distinguishable from other
carbohydrates..., this distinction, which is important for low
carbohydrate diets, [is not reflected in FDA policy]{.underline}
defining carbohydrates for purposes of nutrient content claims or
nutrition labeling."[^2]

Petitioner next argues that the lack of a regulation authorizing
nutrient content claims for total carbohydrates was an oversight due to
the fact that FDA was unaware of the benefits of low-carb diets when it
issued its regulations.[^3] This argument is both incorrect and beside
the point. If the petitioner believes there should be nutrient content
claims for total carbohydrates, the petitioner should submit a petition
to amend the nutrient content claim regulations. The instant petition
requires a showing that the proposed nutrient content claim is
consistent with existing defined nutrient content claims, and it clearly
is not.

The argument that FDA was unaware of the benefits of low-carbohydrate
diets when it refused to allow nutrient content claims for total
carbohydrates is also mistaken. FDA considered and correctly rejected
such claims at the time.[^4] FDA refused to authorize nutrient content
claims for total carbohydrates, because, then as now, there was no
convincing public health justification for such claims:

> Dietary recommendations generally encourage the increased consumption
> of complex carbohydrates, while suggesting that sugars intake be
> limited. Therefore, a nutrient content claim such as 'high in
> carbohydrate' or 'source of carbohydrate' provides misleading dietary
> advice. At best, the claim is misleading in that it does not allow for
> the distinction between high levels of complex carbohydrates and high
> levels of sugars.

56 Fed. Reg. 60421, 60444 (Nov. 27, 1991). The same is true today.
Dietary recommendations generally encourage increased consumption of
some carbohydrates (*e.g*., whole grains) and decreased consumption of
others (*e.g*., sugars).[^5]

b.  **The Proposed "Carbolite" Claim Is Misleading.**

CMA and NCA believe that the "Carbolite" claim is inherently misleading.
There is an obvious disconnect between the claim, which implies that the
labeled food is low in total carbohydrates, and the proposed criteria
for its use, which pertain only to the labeled foods' sugars content.

The petitioner claims that any potential for the claim to mislead
consumers can be corrected by means of qualifying statements or
disclaimers. For example, any potential for the suffix "lite" to mislead
consumers into believing that the labeled product is low in fat or
calories can be avoided by means of a disclaimer stating that the food
is "not necessarily 'light' or 'low' in calories or fat."

The petition does not explain, however, how the proposed disclosures
will prevent consumers from being misled into believing that the labeled
product is low in total carbohydrates. As the petition acknowledges, the
prefix "carbo" in "Carbolite" is a reference to "carbohydrate." In the
absence of any qualifier (*e.g*., "*other* carbohydrate," "*complex*
carbohydrate"), "carbo" refers to total carbohydrates. Most consumers
are likely to interpret the brand name "Carbolite" to mean that the
product is low in total carbohydrates. Yet, petitioner's products are
not "low in total carbohydrates" under any reasonable definition of that
term. According to the label proofs attached to the petition, Carbolite®
bars contain 25 to 27 grams of total carbohydrates per serving. Under
the terms of the petition, however, a food that is "sugar free" or
"reduced sugar" but has substantial amounts of other carbohydrates
(*e.g*., sugar alcohols, fiber) could nevertheless be labeled
"Carbolite."[^6]

The petition argues that "Carbolite" will be understood by consumers to
mean that the labeled product is appropriate for individuals on
low-carbohydrate weight loss diets. However, the petition offers no
evidence to support this assumption, and the petitioner's assurance
cannot overcome the plain meaning of the words used in its brand name.
It should also be noted that Carbolite® products are not marketed in
specialty stores or only to individuals on weight loss diets; they are
marketed to the general public in Wal-Mart and similar stores.

2.  **The Petitioner's First and Fifth Amendment Arguments Are Without
    Merit.**

The petitioner's constitutional arguments are unpersuasive. The U.S.
Supreme Court has enunciated a four-part test for determining whether
government regulation of commercial speech is consistent with the First
Amendment. Under that test, in order to enjoy First Amendment
protection, commercial speech must concern lawful activity and may not
be misleading. *Central Hudson Gas & Electric Corp. v. Public Service
Com'n of New York*, 447 U.S. 557, 561 (1980). As discussed above, the
proposed "Carbolite" claim is inherently misleading and, therefore, not
protected by the First Amendment at all.

The petitioner's Fifth Amendment argument, because it is dependent on
its First Amendment argument, must also fail. We would also question
whether the petitioner can claim valuable property rights in a brand
name that it has used in violation of the law and which apparently is
contested.[^7]

3.  **Granting the Carbolite Petition Would Be Bad Public Policy.**

If FDA grants this petition, it will be effectively authorizing "low
carbohydrate" nutrient content claims. Makers of other "low carb" foods
will likely petition the agency for a defined "low carb" nutrient
content claim, which FDA would be hard-pressed to deny. Allowing a "low
carbohydrate" nutrient content claim would give FDA's blessing to the
currently popular high-protein, low-carbohydrate diets, such as the
Atkins Diet.

CMA and NCA believe this would be unfortunate. It has not yet been
established that such low-carbohydrate diets are a safe way to lose
weight.[^8] In addition, the message to reduce intake of total
carbohydrates, or even "net effective carbohydrates," oversimplifies the
current scientific understanding of the role of carbohydrates in
nutrition (*see* footnote 4 above).

4.  **The Proposed "Carbohydrate Facts" Box Is Not Appropriately
    Included in a Petition Filed Under 21 U.S.C. § 343(r)(4)(A)(iii). It
    Would Require a Petition to Amend FDA's Nutrition Labeling
    Regulation.**

The petition requests that FDA approve use of a "Carbohydrate Facts"
box, placed adjacent to the Nutrition Facts box, that would distinguish
"net effective carbohydrates" from other carbohydrates
nutritionally.[^9] The request for permission to use a "Carbohydrate
Facts" box is not appropriately included in a petition to use an implied
nutrient content claim in a brand name. The proposed "Carbohydrate
Facts" box is a form of nutrition labeling and should be the subject of
a separate petition to amend FDA's nutrition labeling regulation, 21
C.F.R. § 101.9. Turning to the substance of petitioner's request, as
discussed above, CMA and NCA believe that considerably more data is
needed before FDA could amend that regulation to allow the "Carbohydrate
Facts" now being used by the petitioner. We therefore urge FDA to also
deny this aspect of the petition.[^10]

> **\* \* \* \* \***

For the foregoing reasons, we urge FDA to deny the petition.

Respectfully submitted,

/s/

Lawrence T. Graham

President

[^1]: FDA specifically excluded total carbohydrates from "good source,"
    "high," "more", and "high potency" nutrient content claims. 21
    C.F.R. § 101.54(a). While authorizing nutrient content claims for
    calorie and sugars content, FDA did not authorize any claims for
    total carbohydrates. 21 C.F.R. § 101.60.

[^2]: Carbolite® Foods, Inc., Petition for the Use of an Implied
    Nutrient Content Claim in the Brand Name "Carbolite®", October 4,
    2002 (Petition), at 11 (emphasis added).

[^3]: According to the petition, "\[t\]he current FDA policy which
    authorizes no expressed nutrient content claims for 'carbohydrate'
    is reflective of the policy priorities during the period the
    relevant statutory provisions were implemented.... During that time,
    agency policy objectives emphasized the promotion of low fat
    diets.... Only a limited range of issues were considered with
    respect to carbohydrate consumption.... At no time did FDA consider
    the food labeling issues presented by the low carbohydrate diets
    that are popular now...." Petition, at 11.

[^4]: It is worth noting that low-carb diets, such as the Atkins Diet,
    were in existence in 1993, even if they had not yet achieved their
    current popularity.

[^5]: *See, e.g*., U.S. Department of Agriculture, Department of Health
    and Human Services, *Nutrition and Your Health: Dietary Guidelines
    for Americans 2000* ("Eating plenty of whole grains.... may help
    protect you against many chronic diseases."); Hu, FB and WC Willett,
    Optimal diets for prevention of coronary heart disease. *JAMA*.
    2002;288: 2569-2578, 2573 (".... Carbohydrate-containing foods
    should not be judged simply by their GI \[glycemic index\] values;
    the amount of carbohydrates, fiber, and other nutrients are also
    important.").

[^6]: The potential for confusion is enhanced by petitioner's proposed
    use of the term "zero sugar carbs" (or "0 sugar carbs") on its
    labels.

[^7]: See comments submitted by Universal Nutrition, dated December 18,
    2002, stating that it is involved in ongoing litigation with
    Carbolite Foods over the Carbolite® trademark.

[^8]: ".... High-protein, low-carbohydrate diets have not been tested in
    long-term studies. We really need to know their long-term effects
    because these diets.... have effects that go well beyond weight
    loss.... these diets are high in saturated fat and cholesterol and
    so may set the stage for heart disease even as weight decreases....
    high-protein, low-carbohydrate diets could cause kidney damage in
    some people." Walter C. Willett, *Eat, Drink, and Be Healthy*, Simon
    & Schuster, New York, 2001, p. 48.

[^9]: The term "net effective carbohydrates" is not defined by FDA, and
    the petitioner has presented no evidence that it is commonly
    understood by consumers.

[^10]: When CMA wished to distinguish stearic acid from other saturated
    fatty acids, CMA and the Cocoa Merchants Association petitioned FDA
    to amend its nutrition labeling regulations. If Carbolite® is
    permitted to distinguish different carbohydrates in a box outside
    but adjacent to the Nutrition Facts box, then chocolate
    manufacturers should be able to similarly distinguish stearic acid
    from other saturated fats on product labels.