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Review of the Recent FDA Letters to CBD Companies Page 1
Review of the Recent FDA Letters to CBD Companies
In February, 2015, FDA issued 11 warning letters to the
companies listed below for a host of health claims made on product
labels and websites, and on Facebook Comments. Products sold by
these companies claim to cure, mitigate, treat, or prevent things
like bone fractures, cancer, viral tonsillitis, viral hepatitis,
herpes, common cold, influenza, measles, mumps, chicken pox and
more, in humans or animals. Several of the companies sell several
products claiming to contain Cannabidiol (CBD), and market the
products for a host of conditions, including cancer,
neuroinflammation, schizophrenia, anxiety, and more. A search of
all the letters and statements from FDA for the words controlled,
CSA, or illegal return a result of zero. Takeaways: it appears FDA
agrees with those of us that have known it for years: Cannabidiol
in hemp is not a Controlled Substance. Period. Otherwise, FDA would
be talking RICO organization with multiple underlying felonies
against the Officers of the business. FDA didnt include the test
results in the letters, but instead released them to the public as
a warning, which is unprecedented. Drugs, botanicals, and
supplements are routinely the subject of sensationalistic reporting
as to lack of stated potency, it happened recently with ginseng,
Echinacea, St. John's Wort, and ginkgo biloba. Its ironic that FDA
claim no medicine in a product, but nevertheless assert it violates
law by being a medicine. Its clear FDA are monitoring Facebook
posts. Even pet products are subject to the same laws as human
foods or medicines. Companies and Caregivers that make Cannabinoid
products, take notice: this is what FDA enforcement looks like.
Step One. No more of that DEA Swat Team BS. Although FDA does use
their SWAT, they start with a nasty letter, see below. As for the
health claims which are the reason for these letters, weve been
down this road already with dietary supplements in the 80s and 90s.
This exact same kind of enforcement happened back then on Echinacea
health claims, and the like. FDA was ruthless in enforcing no
information on health benefits in the store. Therefore, the
industry got DSHEA 1994 to protect them. We need our version of
DSHEA for Cannabinoids, or we will all be at risk except Big
Pharma. To prevent this type of enforcement, one routinely sees the
standard FDA disclaimer on websites: These statements have not been
evaluated by the Food and Drug Administration. These products are
not intended to diagnose, treat, cure or prevent any disease.
Remember: one can not market unapproved drugs for the diagnosis,
cure, mitigation, treatment, or prevention of diseases in either
humans or animals.
http://www.pharmpro.com/news/2015/02/ny-ag-expands-herbal-supplements-investigation
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Review of the Recent FDA Letters to CBD Companies Page 2
Food and Drug Administration February 3-26, 2015
FDA Warning Letters
Letter
Date Company
Issuing
Office Subject
Close Out
Date
February
26, 2015 Hemp Oil Care
Center for
Drug
Evaluation
and
Research
Unapproved New Drug/Misbranded Not Issued *
February
26, 2015
NanoBiotech
Pharma
Center for
Food
Safety and
Applied
Nutrition
New Drugs/Dietary Supplements/Food
Labeling/Misbranded Not Issued *
February
26, 2015
CBD Life
Holdings LLC dba
Ultra CBD
Center for
Food
Safety and
Applied
Nutrition
New Drugs/Dietary Supplements/Food
Labeling/Misbranded Not Issued *
February
26, 2015
Twin Falls Bio
Tech, LLC
Center for
Food
Safety and
Applied
Nutrition
New Drugs/Dietary Supplements/Food
Labeling/Misbranded Not Issued *
February
26, 2015
Modern Herb
Shop
Center for
Drug
Evaluation
and
Research
Unapproved New Drug/Misbranded Not Issued *
February
26, 2015 cancerherbtea.com
Center for
Food
Safety and
Applied
Nutrition
New Drugs/Dietary Supplements/Food
Labeling/Misbranded Not Issued *
February
26, 2015
Infiniti Creations
Inc
Center for
Drug
Evaluation
and
Research
Unapproved New Drug/Misbranded Not Issued *
February Purecbd.net Center for Unapproved New Drug/Misbranded
Not Issued *
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Review of the Recent FDA Letters to CBD Companies Page 3
Letter
Date Company
Issuing
Office Subject
Close Out
Date
26, 2015 Drug
Evaluation
and
Research
February
26, 2015
Nutreglo
Products, Inc.
Center for
Food
Safety and
Applied
Nutrition
New Drugs/Dietary Supplements/Food
Labeling/Misbranded Not Issued *
February
24, 2015
Canna Companion
LLC
Center for
Veterinary
Medicine
Unapproved New Animal
Drug/Adultered/Misbranded/Misleading Not Issued *
February
24, 2015 Canna Pet LLC
Center for
Veterinary
Medicine
Unapproved New Animal
Drug/Adultered/Misbranded/Misleading Not Issued *
Source:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#recent
AHPA.org
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Review of the Recent FDA Letters to CBD Companies Page 4
Warning Letters and Test Results
In late February 2015, FDA issued several warning letters to
firms that market unapproved drugs for the diagnosis, cure,
mitigation, treatment, or prevention of diseases. Some of these
firms claim that their products contain cannabidiol (CBD). FDA has
tested those products and, in some of them, did not detect any CBD.
It is important to note that these products are not approved by FDA
for the diagnosis, cure, mitigation, treatment, or prevention of
any disease, and often they do not even contain the ingredients
found on the label. Consumers should beware purchasing and using
any such products.
The links to the Warning Letters and the test results for the
CBD-related products are below:
Canna Companion,
LLC
Canna Companion Capsule Size: 4
WA cannaforpets.com 0.1% 0.1% CBDA: 0.3%
THCA: 0.9%
Canna-Pet, LLC CBD Wedges - Canna-
Biscuits for Dogs
WA canna-pet.com negative for cannabinoids
Canna-Pet, LLC Canna-Pet for Cats WA canna-pet.com 0.5%
Canna-Pet, LLC Canna-Pet MaxCBD Capsules for Dogs
WA canna-pet.com 2.6% 0.1% CBC: 0.1%
CBD Life
Holdings LLC dba Ultra CBD
UltraCBD* AZ ultracbd.com negative for cannabinoids
CBD Life
Holdings LLC dba Ultra CBD
UltraCBD* AZ ultracbd.com 0.02% ID
only
CBDA:
0.02%
Hemp Oil Care Hemp Pure Vape E-
Drops: Peached
CA hempoilcare.com negative for cannabinoids
Hemp Oil Care Cibaderm Hemp Salve CA hempoilcare.com CBDA:
0.2%
Hemp Oil Care Cibdex Hemp CBD CA hempoilcare.com 0.3%
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435671.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435671.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435671.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435662.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435662.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435662.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htm
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Review of the Recent FDA Letters to CBD Companies Page 5
Complex Drops - Peppermint
Hemp Oil Care Cibdex Hemp CBD
Complex Drops - Unflavored
CA hempoilcare.com 0.3%
Hemp Oil Care Cibdex Hemp CBD
Complex Drops - Vanilla
CA hempoilcare.com 0.3%
Hemp Oil Care Hemp Honey 21%
Cannabidiol Oil
CA hempoilcare.com negative for cannabinoids
Hemp Oil Care Hemp Honey CBD
Vape Oil - Blueberries & Cream
CA hempoilcare.com negative for cannabinoids
Natural Organic
Solutions
CBD Oil Extract
Capsules (500mg - 10 Capsules)
WA purecbd.net negative for cannabinoids
Natural Organic
Solutions
Real CBD Extract -
CBD (Cannabidiol) Cannabis Extract
Capsules (1500mg - 30 Capsules)
WA purecbd.net 0.5% 0.20% CBDA:
0.1% THCA:
0.03% CBN: ID only
Natural Organic
Solutions
21% CBD Hemp Oil
Treatment
WA purecbd.net negative for cannabinoids
Natural Organic Solutions
26% CBD Hemp Oil Treatment
WA purecbd.net 0.14% 0.45% CBDA: 0.05%
CBN: ID only
Twin Falls Bio Tech, LLC
Arisi-Tol SC arisitol.com 0.2%
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435777.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435777.htm
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Review of the Recent FDA Letters to CBD Companies Page 6
*Multiple samples tested
Abbreviations: 9-tetrahydrocannabinol (9-THC),
Tetrahydrocannabinol (THC), Cannabidiol
(CBD), Cannabinol (CBN), Cannabidiolic Acid (CBDA),
Tetrahydrocannabinolic acid (THCA), Cannabichromene (CBC)
Public Health Focus Expanded Access (Compassionate Use) Page
Last Updated: 03/03/2015
Source:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm
http://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm
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Review of the Recent FDA Letters to CBD Companies Page 7
Canna Companion LLC 2/24/15
Department of Health and Human Services Public Health Service
Food and Drug Administration
February 24, 2015
WARNING LETTER VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED
Canna Companion, LLC Sarah Brandon, DVM Greg Copas, DVM 928 Merea
Lane Sultan, WA 98294 Dear Drs. Brandon and Copas, This letter
concerns the marketing of the product Canna Companion by your firm
Canna Companion, LLC. The U.S. Food and Drug Administration (FDA)
reviewed your product labeling and your website at the Internet
address www.cannaforpets.com, where you promote and sell the
product. We have determined that your product is a drug as defined
by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) [21 U.S.C. 321(g)(1)(B)], as the product is
intended for use in the mitigation, treatment, or prevention of
disease in animals. As discussed below, this product is an
unapproved new animal drug and your marketing of it violates the
FD&C Act. Unapproved New Animal Drug
Statements on your website and product labeling that establish
these intended uses of your product include, but are not limited
to, the following: From the home page, www.cannaforpets.com:
Under the heading Heres how Canna Companion may help your dog or
cat: o Reduce cancer-associated symptoms o Aid in decreasing
severity of dementia o Reduce bronchial spasms in asthmatics
CBD Antibacterial . . . Inhibits cancer cell growth . . .
Reduces blood sugar levels Reduces inflammation, Reduces risk of
artery blockage, . . . Slows bacterial growth, . . . Treats
psoriasis
Under the heading Scientific: o CBD . . . Antidiabetic, . . .
Antimicrobial, Antineoplastic, Anti-proliferative, Antipsoriatic,
Antipsychotic. . . . (http://www.cannaforpets.com/scientific).
Further, claims made on your Facebook page,
https://www.facebook.com/pages/Canna-Companion-LLC/277998209043875,
which also has a link to your website at
http://www.cannaforpets.com/ where products can be purchased
directly, provide additional evidence that your product is intended
for use as a drug:
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Review of the Recent FDA Letters to CBD Companies Page 8
Posts by your company on your Facebook page include the
following:
On November 21, 2014: Good news about our Texas friend, Cyndi
Shes a 14 yr lab who has spinal arthritis & a type of cancer
called adenocarcinoma. Miss Cyndi is responding well to her Canna
C. . . .
On November 19, 2014: Morgaine, one of our lymphoma patients is
responding very positively to the extra strength capsules.
The above referenced products are only intended to be a sampling
of the violative products you are currently marketing. Similarly,
the above referenced claims are only intended to be a sampling of
statements that demonstrate the intended uses of your product.
Because your product is intended to mitigate, treat, or prevent
disease in animals, it is a drug within the meaning of section
201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)]. Further,
this product is a new animal drug, as defined by section 201(v) of
the FD&C Act [21 U.S.C. 321(v)], because it is not generally
recognized among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of animal
drugs, as safe and effective for use under the conditions
prescribed, recommended, or suggested in the labeling. To be
legally marketed, a new animal drug must have an approved new
animal drug application, conditionally approved new animal drug
application, or index listing under sections 512, 571, and 572 of
the FD&C Act [21 U.S.C. 360b, 360ccc, and 360ccc-1]. Your
product is not approved or listed by the FDA, and therefore the
product is considered unsafe under section 512(a) of the FD&C
Act [21 U.S.C. 360b(a)], and adulterated under section 501(a)(5) of
the FD&C Act [21 U.S.C. 351(a)(5)]. Introduction of an
adulterated drug into interstate commerce is prohibited under
section 301(a) of the FD&C Act [21 U.S.C. 331(a)]. Within
fifteen working days of receipt of this letter, please notify this
office in writing of the specific steps that you have taken to
correct violations. Include an explanation of each step being taken
to prevent the recurrence of violations, as well as copies of
related documentation. If you cannot complete corrective action
within fifteen working days, state the reason for the delay and the
time within which you will complete the correction. Your written
response should be sent to Mr. Dillard Woody, Supervisory Consumer
Safety Officer, U.S. Food and Drug Administration, 7519 Standish
Place, Rm 107, Rockville, MD 20855. If you have any questions about
this letter, please contact Mr. Woody at 240-276-9237 or by e-mail
at [email protected]. Sincerely, /S/ Mr. Eric Nelson
Director, Division of Compliance Center for Veterinary Medicine
U.S. Food and Drug Administration
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Review of the Recent FDA Letters to CBD Companies Page 9
Canna Pet LLC 2/24/15
Department of Health and Human Services Public Health Service
Food and Drug Administration
February 24, 2015
WARNING LETTER
VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED Daniel K.
Goldfarb, President Canna-Pet, LLC 10115 Greenwood Ave., N., #191
Seattle, Washington 98133-9197 Dear Mr. Goldfarb,
This letter concerns the marketing of the products Canna-Pet for
Cats, Canna-Pet for Dogs, Canna-Pet MaxCBD Capsules, and
Canna-Biscuits for Dogs, by your firm Canna-Pet, LLC. The U.S. Food
and Drug Administration (FDA) reviewed your product labeling and
your website at the Internet address www.canna-pet.com, where you
promote and sell the products. We have determined that your
products are drugs as defined by section 201(g)(1)(B) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C.
321(g)(1)(B)], as the products are intended for use in the
mitigation, treatment, or prevention of disease in animals. As
discussed below, the products are unapproved new animal drugs and
your marketing of them violates the FD&C Act. Unapproved New
Animal Drugs Statements on your website and product labeling that
establish these intended uses of your products include, but are not
limited to, the following: From the home page,
www.canna-pet.com:
FAQs about Canna-Pet: We find medical benefits, behavioral
benefits, prolonged life, reduced stress, and improved quality of
life with our pets. (http://canna-pet.com/how-to-use/faqs/).
Medical Benefits: We Recommend Canna-Pet as a daily food
additive for all pets, but especially for those with arthritis,
allergies, anxiety or behavior issues, compromised immune systems,
diabetes, digestive issues, nausea, chronic pain, cancer, seizures,
and those receiving palliative care.
(http://canna-pet.com/how-it-works/the-basics/).
Health Benefits of Cannabidiol (CBD) Canna-Pet: Antitumor,
Antiepileptic, Anticancer, Anti-inflammatory, Bone stimulant,
Analgesic, Anti-depressant, Antibacterial, Antipsoriatic,
Antidiabetic, . . . Anti-nausea, Anti-anxiety, . . . Antipsychotic,
. . . Immunosuppressive.
(http://canna-pet.com/how-it-works/phytochemistry-active-compounds/).
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Review of the Recent FDA Letters to CBD Companies Page 10
Canna-Pet MaxCBD Capsules
For pets with extreme issues, who require larger doses of CBD.
Most commonly these are pets suffering from seizures, although we
often see pets with cancers and aggressive tumors, severe chronic
pain, and in end-of-life care using our MaxCBD products.
(https://canna-pet.com/how-it-works/our-products/).
The above referenced products are only intended to be a sampling
of the violative products you are currently marketing. Similarly,
the above referenced claims are only intended to be a sampling of
statements that demonstrate the intended uses of your product.
Because your product is intended to mitigate, treat, or prevent
disease in animals, it is a drug within the meaning of section
201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)]. Further,
this product is a new animal drug, as defined by section 201(v) of
the FD&C Act [21 U.S.C. 321(v)], because it is not generally
recognized among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of animal
drugs, as safe and effective for use under the conditions
prescribed, recommended, or suggested in the labeling. To be
legally marketed, a new animal drug must have an approved new
animal drug application, conditionally approved new animal drug
application, or index listing under sections 512, 571, and 572 of
the FD&C Act [21 U.S.C. 360b, 360ccc, and 360ccc-1]. Your
product is not approved or listed by the FDA, and therefore the
product is considered unsafe under section 512(a) of the FD&C
Act [21 U.S.C. 360b(a)], and adulterated under section 501(a)(5) of
the FD&C Act [21 U.S.C. 351(a)(5)]. Introduction of an
adulterated drug into interstate commerce is prohibited under
section 301(a) of the FD&C Act [21 U.S.C. 331(a)]. [TESTING
RESULTS (if included in the letter)] You should take prompt action
to correct the violations cited in this letter. Failure to promptly
correct these violations may result in legal action without further
notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please
notify this office in writing of the specific steps that you have
taken to correct violations. Include an explanation of each step
being taken to prevent the recurrence of violations, as well as
copies of related documentation. If you cannot complete corrective
action within fifteen working days, state the reason for the delay
and the time within which you will complete the correction. Your
written response should be sent to Mr. Dillard Woody, Supervisory
Consumer Safety Officer, U.S. Food and Drug Administration, 7519
Standish Place, Rm 107, Rockville, MD 20855. If you have any
questions about this letter, please contact Mr. Woody at
240-276-9237 or by e-mail at [email protected]. Sincerely,
/S/ Mr. Eric Nelson Director, Division of Compliance Center for
Veterinary Medicine U.S. Food and Drug Administration
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Review of the Recent FDA Letters to CBD Companies Page 11
CBD Life Holdings LLC dba Ultra CBD 2/26/15
Department of Health and Human Services Public Health Service
Food and Drug Administration
College Park, MD 20740 FEB 26, 2015
WARNING LETTER VIA EXPRESS MAIL
Mohit Asnani CBD Life Holdings LLC dba Ultra CBD 10435 N.
Scottsdale Rd Scottsdale AZ 85253
Re: 445847 Dear Mohit Asnani, This is to advise you that the
U.S. Food and Drug Administration (FDA) reviewed your website at
the Internet address http://www.ultracbd.com in November 2014 and
has determined that you take orders there for the product Ultra
CBD. FDA also reviewed literature that accompanies the sale and
shipment of your product Ultra CBD and has determined that your
website and the literature promote Ultra CBD for conditions that
cause the product to be a drug under section 201(g)(1)(B) of the
Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.
321(g)(1)]. The therapeutic claims on your website and in
promotional literature establish that the product is a drug because
it is intended for use in the cure, mitigation, treatment, or
prevention of disease. As explained further below, introducing or
delivering this product for introduction into interstate commerce
for such uses violates the Act. You may find the Act and FDA
regulations through links on FDAs home page atwww.fda.gov.
Examples of some of the website claims that provide evidence
that your product is intended for use as a drug include: Under the
heading, Research:
[S]tudies have found CBD to possess the following medical
properties: Antipsychotic combats psychosis disorderscombats
neurodegenerative disorders Anti-tumoral combats tumor and cancer
cells combatsdepression disorders
Moreover, when scientific publications are used commercially by
the seller of a product to promote the product to consumers, such
publications may become evidence of the products intended use. For
example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a
publication or reference in the labeling of a dietary supplement is
considered to be a claim about disease treatment or prevention if
the citation refers to a disease use and if, in the context of the
labeling as a whole, the citation implies treatment or prevention
of a disease. The following are examples of publications that are
used to market your product for disease treatment and prevention on
your website and are thus evidence of your products intended use as
a drug:
The Inhibitory Effects of Cannabidiol on Systemic Malignant
Tumors
Cannabidiol inhibits lung cancer cell invasion and metastasis
via intercellular adhesion molecule-1
Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells
by Coordinating the Cross-talk between Apoptosis and Autophagy
http://www.fda.gov/
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Review of the Recent FDA Letters to CBD Companies Page 12
Pathways mediating the effects of cannabidiol on the reduction
of breast cancer cell proliferation, invasion, and metastasis
Examples of claims from the literature that accompanies the sale
and shipment of your Ultra CBD that provide evidence that your
product is intended for use as a drug include:
Treats rheumatoid arthritis
CBD Promotes Cell Death in Breast Cancer Cells
CBDAntibacterial Inhibits Cancer Cell GrowthReduces risk of
artery blockage Further, claims made on your Facebook page
https://www.facebook.com/ultracannabidiol, which includes a link to
your website at http://www.ultracbd.com where products can be
purchased directly, provide additional evidence that your products
are intended for use as drugs: Posts by your company on your
Facebook page include the following:
On October 26, 2014: CBD Protective Against Ebola Virus
Cannabinoids are emerging as a new class of drugs that treat
infections of bacteria, fungi and virus
Your product is not generally recognized as safe and effective
for the above referenced uses and, therefore, the product is a new
drug under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs
may not be legally introduced or delivered for introduction into
interstate commerce without prior approval from the FDA, as
described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also
section 301(d) of the Act [21 U.S.C. 331(d)]. 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. Additionally, your
product is 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 this drug safely for its
intended purposes. Thus, Ultra CBD is misbranded within the meaning
of section 502(f)(1) of the Act, in that its labeling fails to bear
adequate directions for use [21 U.S.C. 352(f)(1)]. The introduction
of a misbranded drug into interstate commerce is a violation of
section 301(a) of the Act [21 U.S.C. 331(a)]. The violations cited
in this letter are not intended to be an all-inclusive list of
violations that exist in connection with your product. You are
responsible for investigating and determining the causes of the
violations identified above and for preventing their recurrence or
the occurrence of other violations. It is your responsibility to
ensure that your firm complies with all requirements of federal law
and FDA regulations. You should take prompt action to correct the
violations cited in this letter. Failure to promptly correct
violations may result in legal action without further notice,
including, without limitation, seizure and injunction. Within 15
working days of receipt of this letter, please notify this office
in writing of the specific steps you have taken to correct the
violations. Include an explanation of each step being taken to
prevent the recurrence of violations, as well as copies of related
documentation. If you cannot complete corrective action within
fifteen working days, state the reason for the delay and the time
within which you will make the correction. If you need additional
information or have questions concerning any products distributed
through your website, please contact the FDA. You may respond in
writing to Food and Drug Administration, Center for Food Safety and
Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD
20740, Attention: Mabel Lee (HFS-608). If you have any questions
concerning this letter, please contact Ms. Lee at 240-402-0972.
Sincerely, /S/ William A. Correll Director Office of Compliance
Center for Food Safety and Applied Nutrition
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Review of the Recent FDA Letters to CBD Companies Page 13
Hemp Oil Care 2/26/15
Department of Health and Human Services Public Health Service
Food and Drug Administration
February 26, 2015
WARNING LETTER VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED
Tigran Lalayan Hemp Oil Care 5511 Virginia Ave Los Angeles, CA
90038 Dear Tigran Lalayan:
This is to advise you that the U.S. Food and Drug Administration
(FDA) reviewed your website at the Internet address
https://www.hempoilcare.com[1] in November 2014 and has determined
that you take orders for several products that you claim contain
cannabidiol (CBD), including but not limited to Cibdex Hemp CBD
Complex Drops, Cibaderm Hemp Salve, Dixie Botanicals Dew Drops Hemp
Oil Supplement, Hemp Honey 21% Cannabidiol Oil, Hemp Honey CBD Vape
Oil, and Hemp Pure Vape E-Drops, which the website promotes for
conditions that cause the products to be drugs under section
201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act)
[21 U.S.C. 321(g)(1)(B)], because the products are intended for use
in the cure, mitigation, treatment, or prevention of disease. As
explained further below, introducing or delivering these products
for introduction into interstate commerce for such uses violates
the Act. Examples of claims observed on your website
https://www.hempoilcare.com that establish the intended use of your
products include, but may not be limited to: On the CBD oil Pure
Vape E-Drops 50mG product webpage,
https://www.hempoilcare.com/product/cbd-oil-pure-vape-drops/: A
literature review from 2009 recapped CBDs documented capabilities
as an . . . antipsychotic . . . vasorelaxant (lower blood
pressure), antispasmodic, anti-ischemic, anti-cancer agent . . .
antibacterial agent, anti-diabetic . . . On the Hemp oil Dixie
Botanicals Dew Drops product webpage,
https://www.hempoilcare.com/product/hemp-oil-dixie-botanicals-dew-drops-100mg/:
EXPLORING SEVEN HEALTH BENEFITS OF CANNABIDIOL (CBD) . . .
antipsychotic, anti-depressant . . . analgesic for rheumatoid
arthritis . . . stimulating new bone growth and strengthening bones
affected by osteoporosis . . . vasorelaxant for glaucoma . . .
atheroscloerosis [sic], anti-ischemic (prevents plaque buildup in
arteries) On the CBD Oil webpage,
https://www.hempoilcare.com/cbd-oil/: Under the heading, Study:
Cannabinoids Could Play A Role In Pancreatic Cancer Treatment:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htm#_ftn1
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Review of the Recent FDA Letters to CBD Companies Page 14
[A study] suggests that cannabinoids could help treat pancreatic
adenocarcinoma one of the most aggressive forms of cancer. [T]he
administration of cannabinoids seemed to induce cancer cell
apoptosis . . .. Under the heading, CBD May Help Reduce Psychotic
Symptoms of Schizophrenia: CBD has shown promise in preventing
cancer from cigarette smoke, reducing heart damage from
chemotherapy . . .. [Researchers] compared benefits of CBD and
amisulpride, a potent antipsychotic, in 42 acute schizophrenia
patients . . . . The researchers found that cannabidiol and
amisulpride were both safe and effective but they declared CBD
superior . . . . It is clear from the claims above that your
marketed products Cibdex Hemp CBD Complex Drops, Cibaderm Hemp
Salve, Dixie Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey
21% Cannabidiol Oil, Hemp Honey CBD Vape Oil, and Hemp Pure Vape
E-Drops are drugs under section 201(g)(1)(B) of the Act because
they are articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease. Your marketed
products Cibdex Hemp CBD Complex Drops, Cibaderm Hemp Salve, Dixie
Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey 21%
Cannabidiol Oil, Hemp Honey CBD Vape Oil, and Hemp Pure Vape
E-Drops 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 use under the conditions prescribed, recommended,
or suggested in the labeling. New drugs may not be legally
introduced or delivered for introduction into interstate commerce
without prior approval from the FDA, as described in section 505(a)
of the Act [21 U.S.C. 355(a)]; see also section 301(d) of the Act
[21 U.S.C. 331(d)]. 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. Additionally, your marketed products
Cibdex Hemp CBD Complex Drops, Cibaderm Hemp Salve, Dixie
Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey 21%
Cannabidiol Oil, Hemp Honey CBD Vape Oil, and Hemp Pure Vape
E-Drops are misbranded within the meaning of section 502(f)(1) of
the Act [21 U.S.C. 352(f)(1)], because the labeling for these
products fails to bear adequate directions for use. Adequate
directions for use means directions under which a layman can use a
drug safely and for the purposes for which it is intended [21 CFR
201.5]. Your marketed 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 this drug safely for
its intended purposes. FDA-approved drugs which bear their
FDA-approved labeling are exempt from the requirements that they
bear adequate directions for use by a layperson [21 CFR
201.100(c)(2) and 201.115]. Because the above-mentioned products
lack FDA-approved applications, they are not exempt under 21 CFR
201.100(c)(2) and 201.115. For these reasons, these products are
misbranded under section 502(f)(1) of the Act. The introduction or
delivery for introduction of a misbranded drug into interstate
commerce is a violation of section 301(a) of the Act [21 U.S.C.
331(a)]. The violations cited in this letter are not intended to be
an all-inclusive statement of violations that exist in connection
with your marketed products. You are responsible for investigating
and determining the causes of the violations identified above and
for preventing their recurrence or the occurrence of other
violations. It is your responsibility to ensure that your firm
complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in
this letter. Failure to promptly correct these violations may
result in legal action without further notice, including, without
limitation, seizure and injunction. Within fifteen working days of
receipt of this letter, please notify this office in writing of the
specific steps you have taken to correct violations. Include an
explanation of each step being taken to prevent the
-
Review of the Recent FDA Letters to CBD Companies Page 15
recurrence of violations, as well as copies of related
documentation. If you cannot complete corrective action within
fifteen working days, state the reason for the delay and the time
within which you will complete the correction. Your response should
be sent to: U.S. Food and Drug Administration CDER/OC/OUDLC 10903
New Hampshire Avenue, WO51 Silver Spring, MD 20993-0002
[email protected] Sincerely, /s/ Cynthia Schnedar, J.D.
Director Office of Compliance Center for Drug Evaluation and
Research [1] FDA notes that http://www.cbdactive.com also redirects
to https://www.hempoilcare.com/ when purchasing CBD oil
products.
mailto:[email protected]:[email protected]://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htm#_ftnref1
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Review of the Recent FDA Letters to CBD Companies Page 16
Purecbd.net 2/26/15
Department of Health and Human Services Public Health Service
Food and Drug Administration
February 26, 2015
WARNING LETTER VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED
Natural Organic Solutions Attn: Joe Cain 1001 Cooper Point Rd. SW
Ste.140 #149 Olympia, WA 98502
1675 Mottman Rd. SW Tumwater, WA 98512 Dear Joe Cain: This is to
advise you that the Food and Drug Administration (FDA) has reviewed
your web site at the internet address www.purecbd.net and your
Etsy.com marketplace store at the internet address
www.etsy.com/shop/PureCBD in February 2015, and has determined that
you take orders for several products claiming to contain
cannabidiol (CBD), such as (but not limited to), CBD Hemp Oil
Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract
Capsules Anti Anxiety Formula, and High CBD Healing Salve. FDA also
reviewed literature which accompanies the sale and shipment of your
products. Based on our review, we have determined that your
websites and accompanying literature promote these products for
conditions that cause them to be drugs under section 201(g)(1)(B)
of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.
321(g)(1)(B)] because they are intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease. As explained
further below, the introduction or delivering these products for
introduction into interstate commerce for such uses violates the
Act. Examples of claims observed in the accompanying literature
titled, Real CBD Cannabis Extracts, that establish the intended use
of your products include, but may not be limited to, the following:
It has shown great promise in treating the most aggressive forms of
Cancer, MS . . . Resistent [sic] Bacteria . . . and so many other
conditions. CBD acts in some experimental models as an
anti-inflammatory . . . and antipsychotic agent, and is therefore a
potential medicine for the treatment of Neuroinflammation . . . and
Schizophrenia, respectively. Examples of claims observed on your
website www.purecbd.net that establish the intended use of your
products include, but may not be limited to, the following: On the
webpage titled, About:
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Review of the Recent FDA Letters to CBD Companies Page 17
Our oil is making a difference in the lives of our patients . .
. Cancer is going into remission. People are recovering from
serious disease. On the webpage titled, Reviews:
CBD hemp oil critical for cancer treatment Stage 4 Metastatic
Breast Cancer Patient has symptom relief Examples of claims
observed on your www.etsy.com/shop/PureCBD marketplace store
website that establish the intended use of your products include,
but may not be limited to, the following: On the webpage titled 30
Capsules CBD Hemp CBD Extract Capsules Anti Anxiety Formula: CBD
Extract Capsules Anti Anxiety Formula This formula has been
specifically designed to prevent Panic/Anxiety Attacks from
occurring. The medicine eliminates many of the peaks and valleys
that are normally responsible for causing a panic attack. On the
webpage titled, 4 Ounces High CBD Healing Salve for Wounds,
Blemishes and Cancers: High CBD Healing Salve for Wounds, Blemishes
and Cancers In the pictures above you can see the amazing results.
The patient presented with third degree burns. Infection was
present. Within 48 hours significant healing has occurred with no
sign of infection. We have treated thousands of patients and have
seen this medicine work! On the webpage titled, 60 Grams of 26% CBD
Hemp Oil Treatment:
We have treated hundreds of patients using this methodology.
There is no stronger treatment available. Here are a just a few
studies using hemp oil to treat various acute disease. Cancer . . .
http://www.ncbi.nlm.nih.gov/pubmed/?term=cbd+cancer MS . . .
http://www.ncbi.nlm.nih.gov/pubmed/?term=cbd+ms Alzheimers . . .
http://www.ncbi.nlm.nih.gov/pubmed/?term=cbd+Alzheimers It is clear
from the claims above that your products, CBD Hemp Oil Treatment,
Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti
Anxiety Formula and High CBD Healing Salve, are drugs under section
201(g)(1)(B) of the Act. Moreover, your products CBD Hemp Oil
Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract
Capsules Anti Anxiety Formula and High CBD Healing Salve 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 use under the conditions prescribed, recommended, or suggested
in their labeling. New drugs may not be legally introduced or
delivered for introduction into interstate commerce without prior
approval from the FDA, as described in section 505(a) of the Act
[21 U.S.C. 355(a)]; see also section 301(d) of the Act [21 U.S.C.
331(d)]. 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. Furthermore, your products CBD Hemp Oil Treatment,
Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti
Anxiety Formula and High CBD Healing Salve are misbranded within
the meaning of section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]
in that their labeling fails to bear adequate
-
Review of the Recent FDA Letters to CBD Companies Page 18
directions for use. Adequate directions for use means directions
under which a layperson can use a drug safely and for the purposes
for which it is intended [21 CFR 201.5]. Your 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.
FDA-approved drugs which bear their FDA-approved labeling are
exempt from the requirements that they bear adequate directions for
use by a layperson [21 CFR 201.100(c)(2) and 201.115]. Because CBD
Hemp Oil Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD
Extract Capsules Anti Anxiety Formula and High CBD Healing Salve
lack FDA-approved applications, they are not exempt under 21 CFR
201.100(c)(2) and 201.115. For these reasons, these products are
misbranded under section 502(f)(1) of the Act. The introduction or
delivery for introduction of a misbranded drug into interstate
commerce is a violation of section 301(a) of the Act [21 U.S.C.
331(a)]. The violations cited in this letter are not intended to be
an all-inclusive statement of violations that exist in connection
with your products and their labeling. You are responsible for
investigating and determining the causes of the violations
identified above and for preventing their recurrence or the
occurrence of other violations. It is your responsibility to assure
that your firm complies with all requirements of federal law and
FDA regulations. You should take prompt action to correct the
violations cited in this letter. Failure to promptly correct these
violations may result in legal action without further notice,
including, without limitation, seizure and injunction. Within
fifteen working days of receipt of this letter, please notify this
office in writing of the specific steps that you have taken to
correct violations. Include an explanation of each step being taken
to prevent the recurrence of violations, as well as copies of
related documentation. If you cannot complete corrective action
within fifteen working days, state the reason for the delay and the
time within which you will complete the correction. Your response
should be sent to: U.S. Food and Drug Administration CDER/OC/OUDLC
10903 New Hampshire Avenue, WO51 Silver Spring, MD 20993-0002
[email protected] Sincerely, /s/ Cynthia Schnedar, J.D.
Director Office of Compliance Center for Drug Evaluation and
Research
mailto:[email protected]
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Review of the Recent FDA Letters to CBD Companies Page 19
Twin Falls Bio Tech, LLC 2/26/15
Department of Health and Human Services Public Health Service
Food and Drug Administration
College Park, MD 20740 FEB 26, 2015
WARNING LETTER VIA EXPRESS MAIL
David Mouser, CEO Twin Falls Bio Tech, LLC 18 Margarita Court
Hilton Head Island, SC 29926
Re: 444405 Dear Mr. David Mouser: This is to advise you that the
Food and Drug Administration (FDA) has reviewed your web site at
the Internet address www.arisitol.com in November 2014 and has
determined that you take orders there for the product Arisi-Tol,
which you also refer to as ArisiTol, Arisitol and Arisi-tol. FDA
also reviewed literature that accompanies the sale and shipment of
your product and has determined that your website and the
literature promote Arisi-Tol for conditions that cause the product
to be a drug under section 201(g)(1)(B) of the Federal Food, Drug,
and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)]. The therapeutic
claims on your website and in promotional literature establish that
the product is a drug because it is intended for use in the cure,
mitigation, treatment, or prevention of disease. As explained
further below, introduction or delivering these products for
introduction into interstate commerce for such uses violates the
Act. You may find the Act and FDA regulations through links on FDAs
home page at www.fda.gov. Examples of some of the claims observed
in the literature titled Read Before Taking that accompanies the
sale and shipment of Arisi-Tol and provide evidence that your
product is intended for use as a drug include:
Case studies have shown it even reduces or inhibits cancer cell
growth in six cancers with breast cancer leading the list.
Over 2/3rds of the 300 individuals, suffering from many forms of
Arthritis, tested our formula and reported it worked!
I developed walking pneumonia. A cough developed effecting [sic]
my bronchial tubes, they became sore and inflamed.So, instead of
taking cough syrup with codeine, I chewed up three Arisi-tol
tablets. In less than an hour, no more burning or inflammation! The
inflammation never returned as I continued taking three tablets a
day.
[T]he knowledge CBD inhibits growth of cancer cells, is why I
continue to take one tablet of Arisitol daily.
If you suffer from Arthritis...try chewing up some Arisi-Tol.
Examples of some of the website claims that provide evidence that
your product is intended for use as a drug include:
http://www.fda.gov/
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Review of the Recent FDA Letters to CBD Companies Page 20
On the webpage titled, United Patients Group Explains Top 5
Cannabinoids that Help Medical Cannabis Patients Heal:
Cannibidiol (CBD) [sic]: CBD helps with cancer, multiple
sclerosisdiabetes, arthritis, dystonia, Chrohns [sic] disease
On the webpage titled, CEO Editorial: Looking for Natural
Alternatives and Dealing with Aging, Memory Loss, Arthritis and
Pain Management:
If you or someone you know is looking for a safer alternative
treatment option for MS, RA, OA,ArisiTol is made just for you.
On the webpage titled, ArisiTol Order Now for Inflammation and
Pain Relief:
Arthritis, Arthritis Pain, RA, Rheumatoid Arthritis, Severe
ArthritisCancer, Cancer Cure, Cancer Remedies...MS Multiple
SclerosisTheilers murine encephalomyelitis virus, Theilers murine
encephalomyelitis virus-induced demyelinating diseaseparkinsons
[sic]
Your product is not generally recognized as safe and effective
for the above referenced uses and, therefore, the product is a new
drug under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs
may not be legally introduced or delivered for introduction into
interstate commerce without prior approval from the FDA, as
described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also
section 301(d) of the Act [21 U.S.C. 331(d)]. 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. Furthermore, your
product is 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 this drug safely for its
intended purposes. Thus, Arisi-Tol is misbranded within the meaning
of section 502(f)(1) of the Act, in that its labeling fails to bear
adequate directions for use [21 U.S.C. 352(f)(1)]. The introduction
of a misbranded drug into interstate commerce is a violation of
section 301(a) of the Act [21 U.S.C. 331(a)]. The above violations
are not meant to be an all-inclusive list of deficiencies in your
products or their labeling. It is your responsibility to ensure
that all of your products and labeling are in compliance with the
laws and regulations enforced by FDA. You should take prompt action
to correct the violations. Failure to promptly correct these
violations may result in regulatory action without further notice,
such as seizure and/or injunction. Please notify this office in
writing within 15 working days from your receipt of this letter as
to the specific steps you have taken to correct the violations
noted above and to assure that similar violations do not occur in
the future. Your response should include any documentation
necessary to show that correction has been achieved. If you cannot
complete all corrections before you respond, please explain the
reason for the delay and the date by which each such item will be
corrected. If you need additional information or have questions
concerning any products distributed through your website, please
contact the FDA You may respond in writing to to Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5100
Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee
(HFS-608, 2C-047). If you have any questions concerning this
letter, please contact Ms. Lee at 240-402-0972. Sincerely, /S/
William A. Correll Director Office of Compliance Center for Food
Safety and Applied Nutrition
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Review of the Recent FDA Letters to CBD Companies Page 21
2015 v1.0 Written by Richard Rose Disclaimer These statements
have not been evaluated by the Food and Drug Administration. These
products are not intended to diagnose, treat, cure or prevent any
disease. Information is provided for informational purposes only
and is not meant to substitute for the advice provided by your own
attorney or doctor. We are providing this on an as is basis and
make no representations or warranties of any kind with respect to
it. No one will be liable for damages arising out of or in
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comprehensive limitation of liability that applies to all damages
of any kind, including (without limitation) compensatory, direct,
indirect or consequential damages, loss of data, income or profit,
loss of or damage to property and claims of third parties. I am not
a lawyer, a doctor, or a scientist.
Trademarks remain the property of their respective owners.
This work is licensed under the Creative Commons Attribution 4.0
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Credit: Medicinal Hemp Association.
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