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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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French Meadow Bakery, Inc. 13-Apr-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Minneapolis DistrictOffice
Central Region
212 Third Avenue South
' Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4134




April 13, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Lynn R. Gordon
President
French Meadow Bakery, Inc.
2610 Lyndale Avenue South
Minneapolis, Minnesota 55408
Dear Ms. Gordon:
Refer to MIN 05 - 12
..
On December 20 and 22, 2004, an investigator from the Food and Drug
Administration, conducted an inspection of your facility at 2610 Lyndale Avenue .
South, Minneapolis, Minnesota. During this inspection, the -investigator collected
label samples from several of your firm's products. After reviewing the labeling for
your products Healthy Hemp Sprouted Bread, Health Seed Spelt Wheat-Free Yeast-
Free Bread, and Cinnamon Raisin Spelt Yeast Free-Organic Bread (each in 24
ounce packages) FDA concludes that these products violate provisions of the
Federal Food, Drug, and Cosmetic Act (the Act). Regulations implementing
. requirements of the Act_ are found in Title 21, Code of Federal Regulations (21 _
CFR). Links to the Act and its regulations may be found at our web site,
www fda.gov.-- -- -. -- ---- -- .
Healthy Hemp Sprouted Bread
.
The product labeling includes the statement, "hempsee.d is one of the most
nutritious plant foods available with . . . a near-perfect composition of the essential
fatty acids, Omega 3 Ss 6. These `good fafs' are necessary for optimum health by
lowering cholesterol.. .:' This claim indicates that the product is intended for use in
treatment, prevention, or mitigation of hypercholesteremia and other
cardiovascular diseases . Such claims are evidence that the product is intended for
use as a drug within the meaning of section 201(g)(1)(B).of the Act (21 U.S.C.
321(g)(1)(B)) ~
Furthermore, your product is not generally recognized as safe and effective for the
above referenced conditions and therefore, the product. is also a "new drug" under
section 201(p) of the Act (21 U .S.C. 321(p)] . New drugs may not be legally
marketed in the United States without prior approval from FDA as described -in
' . . ? j.
Page Two
f
Lynn R. Gordon
April 13, 2005
ti. . .
section 505(a) of the Act [21 U.S.C. 355(a)] . FDA approves a new drug on the basis
of scientific data submitted by a drug sponsor to demonstrate that the drug is safe
and effective.
Your product is also misbranded under section 502(fl(1) of the Act [21 U.S.C .
352(f)(1)] because the labeling for this drug fails to bear adequate directions- for
use. I . .
Even if your product did not include claims that caused it to be a drug, it is a
misbranded food . Your product is misbranded under section 403(r)(1)(A) of the Act
[21 U.S.C. 343(r)(1)(A)] because the product label bears nutrient content claims but
the product does not comply with the regulation that would allow it to bear such,
claims. When used to describe the level of a nutrient, the terms "rich in" and
"high" are defined by regulation to mean that the. product contains 20% or more of
the Daily Reference Value (DRV) or Recommended Daily Intake (RDI) of that
nutrient per reference amount customarily consumed [21 CFR 10J..54(b)(1)]. The
label of your product bears~the claims, "rich source of minerals" and "High iri . ..
Minerals;" however, the product is labeled to contain less than 20% of the RDI for
all the minerals declared in the Nutrition Facts panel (iron, zinc,. magnesium,
selenium, phosphorus, and calcium) . " .
In addition, the product is misbranded .under section 403(q) of the Act [21 U.S .C.'
343(q}] because the product label bears the claim "rich sources of . . . vitamin E,"
but fails to include the amount .per serving of vitamin E as a percent of the RDI, as
required by regulation [21 CFR 101 .9(c)(8)(ii)] . If this product does not contain. at
least 20% of the RDI of vitamin E per reference amount customarily consumed, it
cannot bear a °rich source" claim for vitamin E.
Health Seed S elt Wheat-Free Yeast-Free Bread
Your product is misbranded under section 403(r)(1)(A) of the Act [21 U .S.C. . ,
343(r)(1)(A)] because the label bears a nutrient content claini but the product does
not comply with the regulation which would allow it to bear such a claim. When .
used to describe the level of a nutrient, the term "high" is defined by regulation to
mean that the product contains 20% or more of the RDI or DRV of the nutrient per
reference amount customarily consumed [21 CFR 101 .54(b)(1)] . The label of your
product states, "High in Protein ;" however, the product is labeled to containapproximately
14% of the DRV of protein, per refererice amount .
Your product is further misbranded under section 403(a)(1) .of the Act [21 U.S.C.
343(a)(1)] because the claim on the label that the product is "Wheat Free" is false
and misleading. The product is labeled to contain spelt, a species of wheat.
- Page Three
Lynn R. Gordon
April 13, 2005
Cinnamon Raisin Spelt Yeast Free-Organic Bread
;.:.. ,
The product labeling includes the statement "'Our yeast-free breads have been
recommended for individuals with allergies, digestive problems, candida & -
diabetes." This claim indicates that the product is-intended for use in treatment or
mitigation of the named diseases. Such claims are evidence that the product is
intended for use as a drug within the meaning of section 20 1 (g) (1) (B) of the Act [21
U.S.C.321(g)(1)(B)] .
Furthermore, your product is not generally recognized as safe and effective for the
above referenced conditions and therefore', the product is also a "new drug" under
section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally .
marketed in the United States without prior approval from FDA as described in
section 505(a) of the Act [21 U.S .C. 355(a)] . FDA approves a new drug on the basis
of scientific data submitted by a drug sponsor to demonstrate that the drug is safe
and effective . . -
Your product is also misbranded under section 502(f)(1) of the Act [21, U:S.C.
352(f) (1)] because the labeling for this drug fails to bear adequate directions for
use. -
We request that you notify this office in. writing within 15 working days of receipt of
this letter stating the actions 'you will take to correct the violations and to prevent
their -recurrence. If corrective action cannot be completed within 15 working days,.
state the reason for the delay and the ti-me within which the. corrections will be
completed. .
- Failure to make prompt corrections-may result in further-enforcement action being-=
initiated by the Food~and Drug Administration. This could include seizure of illegal
products and injunction against the manufacturer of illegal products. .
In addition to the violations described above, FDA has the following comments
concerning your product labels:
The ingredients lists for several of your products, such as Healthy Hemp
Sprouted Bread, identify ingredients using terms other than their common
or usual names. For example, an ingredient in the Healthy Hemp Sprouted
Bread lists "Celtic Sea Salt®." As stated in 2 1CFR 101 .4 ; the ingredient
statement must list ingredients by common or usual name . The names
should not include trade names or other extraneous material . .
" Several of your products, including your Healthy Hemp Sprouted Bread, Fat
Flush .Tortillas, and Cinnamon Raisin Spelt Bread, bear claims suggesting
the absence of genetically modified organisms, such as "Non GMO" and'
Page Four
Lynn R. Gordon
April 1.3, 2005
!l
"Coritains NO GMO'S." As explained in the enclosed FDA Draft Guidance for
Industry regarding °Voluntary Labeling Indicating Whether Foods Have or,
Have Not Been Developed,Using Bioengineering," the claim "GMO free" is,not
technically accurate and .may be misleading. We recornmend that you use
this guidance document to develop an accurate statement regarding your
- food and biotechnology :
This letter does not represent a comprehensive .review of all of the products
distributed by your firm; nor does it represent a .complete review of all product
labeling, which may include (among other-materials)- product brochures, product -
catalogs, newsletters and Internet web sites, as applicable. As owner, it is your
responsibility to ensure that all products distributed~by your firm are in -
compliance with the Act and its implementing regulations. -
Your reply should be directed to, Compliance Officer'Iyra S. Wisecup at the address
indicated in the letterhead. Ms.' Wisecup may be reached at (612) 758-7114. _
Sincerely,
0
TSW Jccl
W. Charles Becoat
Director -
Minneapolis District
Enclosure (1)