Here is a warning letter for our little spammers company:
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Robert L. Montgomery
President and CEO
Reliv International, Inc.
136 Chesterfield Industrial Blvd.
Chesterfield, MO 63005
Dear Sir: This letter is in reference to your firm's marketing and
distribution of the product, "Arthaffect." Promotional material
(labeling) for this product makes therapeutic claims that causes the
products to be a drug as defined in Section 201(g) of the Federal
Food, Drug, and Cosmetic Act (the Act).
Examples of the claims include the following:
* "A breakthrough in the fight against degenerative joint
conditions";
* "Published clinical studies [include references to]
osteoarthritis . . . osteo- and chondropathies . . . ";
* "Whether your joints ache from age or an active lifestyle, Reliv
Arthaffect does more than treat the symptoms of degenerative joint
conditions - it focuses on the source of the problems";
* "Traditional joint products simply treat the symptoms of
degenerative joint conditions. In contrast, Reliv Arthaffect focuses
on the source of these problems . . . ";
* "H contains patented Arthred, a protein proven to help fight
degenerative joint conditions";
* ". . . active people who refuse to slow down because of the pain
of degenerative jointconditions"; and "Fights degenerative joint
conditions"; and "Tired of joint pain."
The product is a "new drug" because there is no evidence that it is
generally recognized as safe and effective for its intended use
[Section 201 (p) of the Act]. Therefore, it may not be legally
marketed in this country without an approved new Drug Application
[Section 505(a) of the Act].
It is also misbranded because its labeling fails to bear adequate
directions for use for the condition for which they offer it [Section
502(f)(l) of the Actl. Its labeling is false and misleading as it
suggests that the product be safe and effective for its intended use
when, in fact, this has not been established [Section 502(a) of the
Act].
This letter is not intended to be an all-inclusive review of all
labeling and products your firm markets. It is your responsibility to
ensure that all products marketed by your firm are in compliance with
the Act and its implementing regulations.
We request that you take prompt action to correct these violations.
Failure to promptly correct these violations may result in enforcement
action being initiated by the Food and Drug Administration without
further notice. The Federal Food, Drug, and Cosmetic Act provides for
the seizure of illegal products and for an injlmction against the
manufacturer and/or distributor of illegal products.
Please notify this office in writing within fifteen (15) working days
of receipt of this letter as to the specific steps you have taken to
correct the stated violations. You should also include an explanation
of each step being taken to identify and make corrections to assure
that similar violations will not recur. If corrective action cannot be
completed within 15 working days, state the reason for the delay and
the time within which you will carry out the corrections.
Send your reply to the attention of Andrew H. Paeng, Compliance
Officer, 12 Sunnen Drive, Suite 122, St. Louis, MO 63143-3800..
W. Mike Rogers
Director, Kansas City
District
Mary Z - 27 Jan 2006 03:18 GMT
Reliv also received a warning letter from the FDA in 2001, seems that
company can't follow the rules.
http://www.fda.gov/foi/warning_letters/g1578d.pdf
Look at their salesman sleazy spammers who piss off their potential
customers. Brilliant marketing technique!
Incidentally significantly regulated industries is simply a list of
companies that FDA employees are prohibited from having any financial
interest in. Our spammer is copying meaningless dribble as is most of
the crap spam he posts.
reliv reliv reliv reliv reliv reliv reliv reliv reliv reliv reliv