Can be very effective if it is injected, however taking it orally
doesn't have much science behind it. If you take a look around the web
most sites that do not sell supplements don't offer much positive
information.   Then again it might help your joints by making your
wallet lighter.  -- mz

FDA has an opinion.

jack n dalton

May 5, 2004
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER

Ref. KAN 2004-10
Mark G. Ganaban
Director of Finance
Hyalogic, LLC
P.O. Box 13736
Edwardsville, Kansas 66113-0736

Dear Mr. Ganaban:
An investigator from the Food and Drug Administration inspected your
facility at 10601 Kaw Drive from December 18, 2003 to January 8, 2004.
During this inspection, the investigator collected labeling for your
product, Synthovial Seven. We have reviewed the collected labeling as well
as your web site at www.hyalogic.com. This review shows serious violations
of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of
your product Synthovial Seven. You can find the Act and implementing
regulations through links on FDA's Internet home page at:
http://www.fda.gov/.

Under the Act, articles intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man are drugs [Section 201(g)(1)(B) of
the Act]. The labeling of your product Synthovial Seven bears the following
claims:

Internet web site
"Hyaluronic acid (HA) has been proven by numerous medical studies to
alleviate pain and suffering from arthritis of the knee and other joints
Synthovial 7(tm) is an oral solution made from premium grade hyaluronic
acid..
   . "
"Patent Approved for.. . Arthritis and Fibromyalgia."
Product package:
"Eliminate joint pain and enjoy...faster wound healing." These claims cause
your product to be drugs as defined in section 201 (g)(1)(B) of the Act.
Because these products are not generally recognized as safe and effective
when used as labeled, they are also new drugs as defined in section 201(p)
of the Act. Under section 505 of the Act, a new drug may not be legally
marketed in the United States without an approved New Drug Application
(NDA).  Your product is labeled as a dietary supplement; however, the
labeling also contains claims that cause the product to be a drug. Even if
the labeling for this product did not contain such claims, as a dietary
supplement the product would violate other provisions of the Act. Under the
Act, dietary supplements may be legally marketed with claims that they
affect the structure or function of the body (structure/function claims), if
certain requirements are met. The manufacturer of a dietary supplement
containing a "structure/function" claim in the product's labeling must have
substantiation that the claim is truthful and not misleading [Section
403(r)(6)(B) of the Act].  The labeling of your product Synthovial Seven
bears the following structure/function claims:
Internet web site:

"More cushioning and lubricating properties for the joints... "
"Other benefits may include: Increased Mobility... "

Product package:

"As we age, the body produces less and less hyaluronic acid. The joints
become stiff, the movement painful... [E]njoy the...anti-aging benefits of
hyaluronic acid throughout the body: increased mobility..."
We have reviewed these claims and have concluded that they are not supported
by reliable scientific evidence. Because these claims lack substantiation,
they are false or misleading, and cause your product to be misbranded under
sections 403(a)(1) and 403(r)(6)(B) of the Act. It is a violation of section
301(a) of the Act to introduce or deliver for introduction into interstate
commerce any food, including a dietary supplement, that is misbranded.  This
letter is not an all-inclusive review of the products that your firm markets
and the claims you make in your product labels and labeling, including your
Internet website, www.hyalogic.com. It is your responsibility to ensure that
all products marketed by your firm comply with the Act and its implementing
regulations.

The Act authorizes the seizure of illegal products and injunctions against
the manufacturers and distributors of those products. You should take prompt
action to correct the violations identified in this letter. Failure to do so
may result in enforcement action without further notice.
Please advise this office, in writing and within fifteen (15) working days
of receipt of this letter, as to the specific steps that you have taken to
correct any violations and to assure that similar violations do not occur.

If corrective action cannot be completed within fifteen working days, state
the reason for the delay and the time within which the corrections will be
made.  Your reply should be sent to the attention of Joseph G. Kramer,
Compliance Officer, at the above address.
Sincerely yours,
/s/
Charles W. Sedgwick
District Director
Kansas City District
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Bad News:  I took these for two weeks with no apparent results.
According to the product hype I should have noticed an improvement in a
couple of days.

Good News:  the first bottle cost me 6.95 for shipping and they
cancelled any future orders without any arguments.