The FDA has apparently decided that Diamond's on-package claims of walnuts' heart-healthiness render them medication, and demanded that they be taken off the shelf and submitted for testing, regulation, and prescription by a licensed physician.
You heard me.
WALNUTS.
That's straight off the FDA website -- http://www.fda.gov/iceci/enforcementact ... 202825.htm is the URL I pulled it from.
--
Sucrose Octanitrate.
Proof positive that with sufficient motivation, you can make anything explode.
You heard me.
WALNUTS.
Quote:Diamond Food Inc. 2/22/10
[table]
Department of Health and Human Services
Public Health Service
Food and Drug Administration
[/table] College Park, MD 20740
FEB 22 2010
WARNING LETTER
VIA OVERNIGHT MAIL
Michael J Mendes, President and Chief Executive
Diamond Food, Inc.
1050 S. Diamond St.
Stockton, California 95201
Re: CFSAN-OC-10-11
Dear Mr. Mendes:
The Food and Drug Administration (FDA) has reviewed the label for your
"Diamond of California Shelled Walnuts" products and your website at
www.diamondnuts.com. Based on our review, we have concluded that your
walnut products are in violation of the Federal Food, Drug, and Cosmetic
Act (the Act) and the applicable regulations in Title 21, Code of
Federal Regulations (21 CFR). You can find copies of the Act and these
regulations through links in FDA's home page at http://www.fda.gov.
Website
Based on claims made on your firm's website, we have determined that
your walnut products are promoted for conditions that cause them to be
drugs because these products are intended for use in the prevention,
mitigation, and treatment of disease. The following are examples of the
claims made on your firm's website under the heading of a web page
stating "OMEGA-3s ... Every time you munch a few walnuts, you're doing
your body a big favor.":
• "Studies indicate that the omega-3 fatty acids found in walnuts may
help lower cholesterol; protect against heart disease, stroke and some
cancers; ease arthritis and other inflammatory diseases; and even fight
depression and other mental illnesses."
• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "
• "n treating major depression, for example, omega-3s seem to work by
making it easier for brain cell receptors to process mood-related
signals from neighboring neurons."
• "The omega-3s found in fish oil are
thought to be responsible for the significantly lower incidence of
breast cancer in Japanese women as compared to women in the United
States."
Because of these intended uses, your walnut products are drugs within
the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)].
Your walnut products are also new drugs under section 201(p) of the Act
[21 U.S.C. § 321(p)] because they are not generally recognized as safe
and effective for the above referenced conditions. Therefore, under
section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally
marketed with the above claims in the United States without an approved
new drug application. Additionally, your walnut products are offered for
conditions that are not amenable to self-diagnosis and treatment by
individuals who are not medical practitioners; therefore, adequate
directions for use cannot be written so that a layperson can use these
drugs safely for their intended purposes. Thus, your walnut products are
also misbranded under section 502(f)(1) of the Act, in that the
labeling for these drugs fails to bear adequate directions for use [21
U.S.C. § 352(f)(1)].
Your walnut products are also misbranded under section 403(r)(1)(B) of
the Act [21 U.S.C. § 343(r)(1)(B)] because your firm's website also
contains several additional unauthorized health claims. The following
are examples of the claims made on your firm's website:
• "Studies have also shown that omega-3s may lower the risk of stroke ..."
• "[T]here's good evidence that omega-3s can increase HDL (good
cholesterol), further reducing the risk of stroke and heart disease."
Product Label
Further, your "Diamond of California Shelled Walnut" product is
misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. §
343(r)(1)(B)] in that your product bears health claims that are not
authorized by the FDA. The front and back of your product label bears
the phrase "OMEGA 3 2.5 g per serving." Within the context of this
label, the heart symbols adjacent to information about the amount of
omega-3 in the product, constitute implied health claims about
consumption of omega-3 and a reduced risk of coronary heart disease [21
CFR 101. 14(a)].
The back of your product label also bears the following statement: "The
omega-3 in walnuts can help you get the proper balance of fatty acids
your body needs for promoting and maintaining heart health. In fact,
according to the Food and Drug Administration, supportive but not
conclusive research shows that eating 1.5 oz of walnuts per day, as part
of a low saturated fat and low cholesterol diet, and not resulting in
increased caloric intake, may reduce the risk of coronary heart disease.
Please refer to nutrition information for fat content and other details
about the nutritional profile of walnuts." Although FDA exercises
enforcement discretion over the last two sentences of this statement,
which meet the criteria for a qualified health claim for walnuts and
coronary heart disease, the last two sentences read in conjunction with
the first sentence makes the entire statement an unauthorized health
claim.
The statement suggests that the evidence supporting a relationship
between walnuts and coronary heart disease is related to the omega-3
fatty acid content of walnuts. There is not sufficient evidence to
identify a biologically active substance in walnuts that reduces the
risk of CHD. Therefore, the above statement is an unauthorized health
claim. This letter is not intended to be an inclusive review of your
products and their labeling. It is your responsibility to ensure that
all of your products comply with the Act and its implementing
regulations.
You should take prompt action to correct these violations. Failure to do
so may result in regulatory action without further notice. Such action
may include, but is not limited to, seizure or injunction.
Please respond in writing within 15 working days from your receipt of
this letter. Your response should outline the specific actions you are
taking to correct these violations and to prevent similar violations.
You should include in your response documentation such as revised labels
or other useful information that would assist us in evaluating your
corrections. If you cannot complete all corrections before you respond,
we expect that you will explain the reason for the delay and state when
you will correct any remaining violations.
Your response should be directed to Latasha Robinson, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5100 Paint
Branch Parkway, Office of Compliance (HFS-608), Division of
Enforcement, College Park, Maryland 20740-3835. If you have any
questions, you may contact Ms. Robinson at 301-436-1890.
Sincerely,
/S/
Roberta Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc: San Francisco District Office
That's straight off the FDA website -- http://www.fda.gov/iceci/enforcementact ... 202825.htm is the URL I pulled it from.
--
Sucrose Octanitrate.
Proof positive that with sufficient motivation, you can make anything explode.
