- Dear Jeff,
-
- Here is a copy of a letter received from the FDA - Dec.
2nd, 2002. It is alarming to see the trend that is going on in our industry.
Natural health care supplements are once again under abusive attack. Most
of what is written in the letter about these products is taken from the
actual bottles themselves - which are not manufactured by us - and all
of these products are sold by many, many other companies.
-
- A particularly alarming aspect of this letter is the
fact that they are targeting the HHA Newsletter which has been published
since 1988 and is protected under the constitution of the US - Freedom
of Press and Freedom of Speech. Since this is the second letter of this
type we have received by the FDA, we feel that in the near future, valuable
information about the use of natural products will begin to disappear from
Natural Health web sites all over the world. People, this is alarming!
We should be headed in the other direction, not backwards. All I can tell
you, is do your research now! Get books, order study courses on natural
therapy, stock products and learn how to use these valuable alternatives,
because they DO work and they are in many cases a much safer and humane
alternative.
-
- Dr. McCain
-
- Here is the letter:
- Dear Dr. McCain,
- The Food and Drug Administration (FDA) has reviewed your
web site, at <http://www.herbalhealer.com>http://www.herbalhealer.com,
and several Herbal Healer Academy Newsletters. This is to advise you that
many veterinary products your firm is marketing on its Internet site and
through its newsletters are in violation of the Federal Food, Drug and
Cosmetic Act. (the Act). You can find the Act along with the drug, food,
and food additives regulations through the FDA's web site at <http://www.fda.com>http://www.fda.com
- The intended use of the following products are conveyed
through your claims...
- Diatomaceous Earth - natural elimination of parasites
in livestock.
- Glucosamine/Chondroitin - helps in recovery from broken
bones, stiffness and arthritic conditions.
- ProMSM Sulphur - arthritic conditions, healing from surgery
and trauma, flea infestations.
- Pro Yucca - for all arthritic conditions - dogs, cats,
horses.
- Colloidal Silver - effective antibiotic, will fight bacterial,
viral and fungal infections. respiratory diseases (chickens)...good for
cysts in dogs, terminal cancer, infections and swelling due to infections,
cystitis.
- 4-Herb Tea - Mare with Melanoma was helped... tumors
are shrinking, also cat tumor testimonial.
- Olive Leaf Liquid - anti-viral ...
- as well as the intended use of some of the other products
suggested by their names, Homeopathics: Anxiety Formula, Arthritis Formula,
Fleas & Tick Bites, Indigestion & Gas, and so on...
- These statements and product names establish that the
associated products are "drugs" as defined in section 201(g)(1)
of the Act. This is because the statements and product names convey that
the products are intended for use as a cure, mitigation, treatment, or
prevention of disease. Most or all of the products are also likely to be
"new animal drugs" under section 210(v) of the Act since we are
unaware of any evidence that any of the products are generally recognized
as safe and effective for their intended uses. New animal drugs that are
not covered and approved as required by section 512(a)(1)(A) of the Act,
cannot be legally marketed in the United States.
-
- We note that the use of these products by animal owners
for the above promoted claims could potentially endanger the health of
the animal by delaying timely, appropriate treatment by a veterinary practitioner.
In addition, no product containing Colloidal Silver has been approved for
any use in any animal species.
-
- You should take prompt action to correct these violations.
This letter is not intended to be an all inclusive review of your Internet
site, newsletters, and the products your firm markets.
- Office of Surveillance and Compliance
- Center For Veterinary Medicine FDA
- signed - Gloria Dunnanan
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