Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA411201
`ESTTA Tracking number:
`05/26/2011
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`92053495
`Plaintiff
`Isotonic OPC Antioxidants, Inc.
`SENGEN SUN PHD
`ISOTONIC OPC ANTIOXIDANT INC
`8838 LA CAMESA STREET
`SAN DIEGO, CA 92129
`UNITED STATES
`info@amerinutra.net
`Opposition/Response to Motion
`Sengen Sun, PhD
`info@amerinutra.net
`/Sengen Sun/
`05/26/2011
`Supplement to Response by Petitioner.pdf ( 12 pages )(35423 bytes )
`Attachment_13.pdf ( 3 pages )(66093 bytes )
`Attachment_14.pdf ( 1 page )(252550 bytes )
`
`Proceeding
`Party
`
`Correspondence
`Address
`
`Submission
`Filer's Name
`Filer's e-mail
`Signature
`Date
`Attachments
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
`
`
`Isotonic OPC Antioxidants, Inc.
`
`Petitioner,
`
`Cancellation No. 92053495
`
`vs.
`
`
`
`Horphag Research Management S. A.
`
`Registration No. 1769633
`
`Registrant.
`
`
`
`
`
`
`
`
`
`PETITIONER’S SUPPLEMENT TO ITS RESPONSE TO
`
`REGISTRANT’S MOTION FOR JUDGEMENT ON PLEADINGS
`
`Petitioner frankly and respectfully admits that Petitioner was confused by the Board Order dated
`
`on 04/28/2011: “DATES REMAIN AS PREVIOUSLY SET”, which was posted two days after
`
`RESPONDANT’S MOTION FOR JUDGMENT ON THE PLEADINGS. Petitioner wishes to
`
`argue respectfully that this Board Order would confuse any new user of the TTAB system on the
`
`current status of the proceeding on that date. Consequently from the confusion, Petitioner filed a
`
`motion
`
`for ACR on 04/29/2011, which contains an
`
`incomplete RESPONSE TO
`
`REGISTRANT’S MOTION FOR JUDGEMENT ON PLEADINGS. Therefore, Petitioner
`
`wishes to make this supplement to clarify or emphasize the key points, and firmly requests the
`
`Board dismiss RESPONDANT’S MOTION FOR JUDGMENT ON THE PLEADINGS:
`
`
`
`
`
`1
`
`

`
`1. One of the key points Petitioner made in its Response on April 29, 2009 is that the mark
`
`Pycnogenol ® has been improperly used for the last 2 decades in the scientific literature,
`
`including in the article titles, regardless the symbol ® is used or not. There are many statements
`
`in the Motion for ACR and Response that indicate that Petitioner has been continuously
`
`pursuing this point since it filed this Petition. For 3 examples of the statements indicating this:
`
`(1) “scientific information must be described based on scientific/generic names, not
`
`trademarks.” Page 2.
`
`(2) “The first issue is whether it is legitimate that a commercial company is spamming
`
`maliciously the scientific literature using its trademark.” Page 7.
`
`(3) “It is clear that Registrant has been making massive efforts for about two decades in
`
`enforcing the spamming of the scientific literature using the mark, in attempt to use the mark to
`
`block its commercial competitors from citing the public scientific information.” Page 8.
`
`Petitioner further elaborated this point by presenting Attachemt_4, and by giving the 2 particular
`
`examples of the article titles where Pycnogenol ® is used on Page 9. There are numerous other
`
`pieces of evidence indicated that Petitioner did not and does not abandon this key issue, in
`
`contrary to Registrant’s groundless claim.
`
`
`
`2. When one talks about the word “pycnogenol” instead of the product Pycnogenol ® pine bark
`
`extract, the symbol ® does not have to be there. For example, “the world's most prominent
`
`scientist in this field, Professor Masquelier, coined the word pycnogenol for OPC, 3 decades ago
`
`in France”. This quoted statement is just a historical fact that can be mentioned by any one and
`
`under any occasions, as guaranteed by the US Constitution on the freedom of speech. It is
`
`Registrant’s problem to adopt a pre-existing scientific/generic term as a trademark. As
`
`
`
`2
`
`

`
`guaranteed by the US Constitution, it is a fair use to mention “pycnogenol” as a word because it
`
`pre-existed as a scientific/generic name for pine bark OPC in the human languages before it was
`
`registered as trademark in US, when one does not mean any particular product. There is a
`
`difference in nature between how the word “pycnogenol” (created by Masquelier) is used and
`
`how the product Pycnogenol ® is used. Analogously, Apple ® computer contains a word
`
`element “apple”. Any one has the legal right for fair use of the word “apple” without the format
`
`of a trademark, when one does not mean the product.
`
`
`
`3. Petitioner’s citations of the public scientific information related to Pycnogenol ® in
`
`Petitioner’s own words are seen by Registrant as unclean hands. Petitioner firmly denies this
`
`allegation, and is very excited and is looking forward to a decision as a guidance from the
`
`Board. According to Registrant, Petitioner also made its hands unclean in the petitioning process
`
`and in the petitioning documents before the TTAB. According to Petitioner, however, the issues
`
`in the petition are either unintended technical errors or fair uses of the word part while not
`
`mentioning the product. Petitioner just hopes that the Board will recognize these different
`
`arguments in its decision. Petitioner is sure that any laws recognize the difference in nature
`
`between an intended action and an unintended action.
`
`
`
`4. Science is interchangeable unless protected by the Patent and Copyright Laws. This is the
`
`point of severe disputes between the two parties. Given such a severity of disputes, it is nothing
`
`wrong that Petitioner expects “a valuable guidance from TTAB – the authority of intellectual
`
`property laws, by filing this petition.” The Board makes a decision (a law) as a “guidance” for
`
`disputes on commercial interests. Registrant made its own narrow and self-centered explanation
`
`
`
`3
`
`

`
`of “guidance” to serve for its own purpose in attacking Petitioner’s realistic and respectful
`
`attitude towards the Board. Petitioner does not have its own laws, but beliefs on laws and
`
`knowledge on science and laws.
`
`Science must have its reproducibility for the underlying physical substances of different sources
`
`– interchangeable. If science were not generally interchangeable, it would be garbage or
`
`commercial scams. Science is interchangeable based on scientific/generic names and according
`
`to the corresponding physical and chemical structures. Scientific studies are studies of physical
`
`substance(s) in terms of the scientific/generic names. The human safety profiles of physical
`
`substances are interchangeable in terms of scientific/generic names. It is not science to publish
`
`un-interchangeable human safety data for a mysterious commercial product. This is just a
`
`common sense in our working experience. Petitioner’s corporate officer has done this daily for
`
`decades – interchanging science every day. Even though Petitioner is not aware of any law or
`
`authority to support “science is interchangeable”, Petitioner is aware of the meanings of
`
`“public”, “publish”, “published”, “publishing”, “publications’, etc.. The human linguistic rules
`
`are the first law above anything else. It is interchangeable simply because it is public, against
`
`“private”, “privatized” and “privatization”. In an analogous statement, “it is legal for one to eat
`
`every day”, which is supported by common sense, not by a written law. If you claim that it is
`
`illegal for one to eat, you have to cite any law in writing to support your claim. There is not such
`
`a law because if one does not eat, he/she will die soon. Registrant has the obligation to give its
`
`legal basis to claim that “Science Is Not Interchangeable”. There is not such a law to support
`
`Registrant’s claim because if science were not interchangeable, science would be garbage. The
`
`purpose of science is not to pack a commercial product as a mysterious collection of matter, and
`
`to claim magic effects on the human body. Natural complexity is not the excuse for scientists to
`
`
`
`4
`
`

`
`use a commercial name in replacement of scientific/generic name in description of science. In
`
`the exact opposite, the task of science is to analyze and dissect any complex physical matter in
`
`term of scientific/generic name(s). If all commercial companies invest big monies in their own
`
`un-interchangeable science, science is going to die in no time!
`
`It is clear that Registrant has made massive effort for about 2 decades to prevent “me too”, and
`
`has converted a piece of the public territory as its private advertising tool, and caused this piece
`
`of science “Not Interchangeable”, where they have made massive claims like “Pycnogenol®
`
`reduces blood pressure in hypertensive patients not taking medication.”
`
`
`
`5. Dietary Supplement Health and Education Act enacted in 1994 (DSHEA-1994) includes 5
`
`key elements. One of them says: “Manufacturers are only permitted to make certain types of
`
`claims, and may not make false or misleading claims of any kind”. By linguistic reasoning, “any
`
`kind” includes “any where” and “by whomever” under the influence of the commercial scams of
`
`the manufacturer.
`
`Under its strong financial influence, Registrant has been engaged in about 2-decade long scams
`
`in targeting science as a safe harbor and in recruiting others including some scientists and a US
`
`government agency in Registrant’s behalf to make “some kinds” of false or misleading claims,
`
`which are prohibited by DSHEA-1994 and the Federal Food, Drug, and Cosmetic Act.
`
`Attachment_11, filed by Petitioner on April 29, 2011, has this quote: “We regard the
`
`promotional literature as labeling, since it makes therapeutic claims”, indicating that FDA
`
`enforces the Act and prohibit the “any kind”. The event of “makes therapeutic claims” for a
`
`dietary supplement product is the sole reason for the law enforcement by the FDA. The FDA
`
`actively enforces this rule as shown by another enforcement letter related to Pycnogenol ® as
`
`
`
`5
`
`

`
`attached as Attachment_13, which has a colorfully highlighted subtitle: “Inspections,
`
`Compliance, Enforcement, and Criminal Investigations”. Attachment_13 contains such a quote:
`
`“However, untrue or misleading information in one part of your site will not be mitigated by
`
`inclusion of such a "disclaimer." Cf. 21 C.F.R.202.1(e)(3)”.
`
`It should be noted that a scientist may use scientific/generic name(s) of physical substance(s)
`
`such as “pine bark extract” in description of the corresponding drug effects. Strictly say, it is a
`
`crime even for a scientist to use dietary supplement product name/mark for this purpose
`
`anywhere, knowingly or unknowingly. Many of the article titles in Attachment 1, filed with this
`
`initial Petition on January 9, 2011, are the crime scenes, which will never disappear until this
`
`trademark Pycnogenol ® is cancelled, regardless whether the symbol ® is used or not.
`
`As those Pycnogenol ®-related “scientific articles” have been converted by Registrant as non-
`
`interchangeable, and as privatized promotional literature for its marketing purpose, any
`
`statements of therapeutic claims in these articles for this dietary supplement product are criminal
`
`acts. They are factually the same “promotional literature as labeling”, simply because they make
`
`direct “therapeutic claims” for a dietary supplement product, as reasoned from the quotes above
`
`in Attachment_11, and Attachment_13.
`
`Registrant’s 2-decade massive effort based on its strong financial power has caused substantial
`
`confusion among scientists and even a US government agency. Every scientist has to, first, act
`
`as Registrant’s free advertising agent, if he/she wants to cite the possible drug effects of a class
`
`chemicals from pine bark. A US government agency (NIH) has become a free advertising agent
`
`for Registrant in advertising the drug effects for a dietary supplement product. These crimes,
`
`committed by Registrant, some scientists and the NIH, knowingly or unknowingly, must be
`
`stopped unconditionally. There is nothing wrong that “Petitioner wishes to criticize those
`
`
`
`6
`
`

`
`scientists, scholars, and some organizations….” on any standards for unlawful and misleading
`
`statements of any kinds all together and no matter where, and for scientific descriptions of
`
`therapeutic effects using a trademark of dietary supplement, under the influence of Registrant
`
`annual budget of US$1.5M in attacking science. Petitioner does not abuse this legal system.
`
`TTAB – the court is exactly the right place to complain about the crimes by anyone, related to a
`
`trademark.
`
`
`
`6. Petitioner wishes
`
`to re-emphasize
`
`that
`
`in
`
`the following quoted paragraph from
`
`“MONOGRAPH FOR PYCNOGENOL” (page 3 of Attachment_6, filed on April 29, 2011),
`
`every sentence is a therapeutic claim or disease benefit claim for Pycnogenol ® product (without
`
`exception!), as defined in Section 201 (g) of the Federal Food, Drug, and Cosmetic Act:
`
`“To summarize the clinical findings, Pycnogenol may help decrease edema formation in the
`
`lower legs, such as in people with chronic venous insufficiency. Pycnogenol improves
`
`endothelial function resulting in improved blood circulation, lowered blood pressure in
`
`hypertension, and normalization of platelet coagulability. Pycnogenol has been shown to
`
`improve glycemic control in patients with type 2 diabetes and to improve treatment of diabetic
`
`ulcers. Preliminary studies suggest that Pycnogenol may be beneficial for children with ADHD
`
`and may be a useful adjunct therapy for patients with asthma. Pycnogenol may help reduce pain
`
`associated with menstrual disorders. Several clinical studies report that Pycnogenol may
`
`improve subjective symptoms of knee osteoarthritis.”
`
`There is no scientific evidence acceptable to FDA to support these direct therapeutic claims for a
`
`dietary supplement product. These disease benefit claims in marketing literature or articles are
`
`prohibited by the laws, regardless what the word “regulation” really means!
`
`
`
`7
`
`

`
`
`
`7. “MONOGRAPH FOR PYCNOGENOL” (Attachment_6, filed on April 29, 2011) is the
`
`promotional literature, - undeniably a label for Pycnogenol ® to be a drug;
`
`Scientific publications have become the private labels for Pycnogenol ® to be a drug;
`
`The NIH website has become the private labels for Pycnogenol ® to be a drug….
`
`Registrant has been very successful for about 2 decades in labeling its Pycnogenol ® to be a
`
`drug in many different ways. That is exactly how the Pycnogenol ® has been so famous to be a
`
`BUZZ word on the US market, - marketed as a drug unproven by the US FDA.
`
`
`
`8. Petitioner, owned by US Citizens, is a US domestic business entity, and is guaranteed the
`
`freedom by the US Constitution to do business within the US border. Petitioner has the
`
`obligation to serve its fellow citizens within the border and does not have the constitutional
`
`obligation to serve any international individuals or organizations. The US government has its
`
`constitutional obligations in making laws to protect its citizens from any harm from any
`
`international entities that the US government permit to do business in US. The US government
`
`does not have the constitutional authority to force its citizen to engage in any business activity
`
`across the border, while seeking protection within US, and while there is an option to the US
`
`citizen for a needed activity to be accomplished within the border.
`
`Petitioner does not have any international business experience and experienced difficulty to
`
`serve this international Registrant, because the US government failed in making a law to require
`
`domestic contacting addresses filed in the USPTO system for international registrants. This falls
`
`below some current international standards. For example, the Chinese law requires that any
`
`
`
`8
`
`

`
`international trademark registrant have a designated domestic legal representative on file, so
`
`their own citizens can make any complaints easily.
`
`It is evident that Registrant for Pycnogenol ® has had the same US legal representative on
`
`intellectual property laws since this mark was registered about 2 decades ago. Registrant does
`
`not file, in the USPTO electronic system, the document of contacting information of its US legal
`
`counsel, who works full-time in the New York City. This clearly indicates that this international
`
`Registrant, for the sake of its own interest, wants to deliberately cause inconvenience and harm
`
`to US citizens who don’t have any international business experience.
`
`If an international Registrant’s legal counsel, who works full-time in the New York City, has the
`
`right to make any complaint to Petitioner, the legal counsel acquires the obligation to accept any
`
`related complaints that Petitioner makes about the international Registrant. Any one, who mails
`
`a legal document to me, acquires the obligation to accept a legal document from me for the same
`
`legal issue. The US Constitution does not permit any US government to discriminate against its
`
`own Citizen in favor of an international individual or entity for the convenience of
`
`communication in the exchange of legal documents.
`
`Overall, the initial service of Petition documents to Registrant is a valid service.
`
`
`
`9. Petitioner respectfully requests that the Board consider the fact which party had the unclean
`
`hands at the first place by looking at the historical events or who violated the related laws at the
`
`first place. Here is a brief list of historical events:
`
`(1). Pynogenol ® Filing Date: 1990-01-26
`
`(2). Registration Date: 1993-05-11
`
`(3). Petitioner started a new business with a website amerinutra.net: 2010-02-18
`
`
`
`9
`
`

`
`(4). Petitioner updated its websites with www.opc-1-2-3.com and
`
`http://stores.isotonic-opc.net : ~August, 2010
`
`(5) Petitioner noticed a law firm was exploiting Petitioner’s websites: 10-2010.
`
` (5). Registrant (via its attorney) sent the first demanding letter to Petitioner: 2010-11-19.
`
`(6) E-mail communications between the two parties: 2010-11-19 ~ 2010-12-20.
`
`(7) Registrant sent an ultimatum via e-mail to litigate Petitioner for trademark infringement
`
`(Attachment 2 in the initial Petition for Cancellation): 2010-12-20
`
`(8) After receipt of the ultimatum, Petitioner sent 3 e-mails to registrant to explain, but did not
`
`hear anything back from Registrant.
`
`(9) Registrant stepped up to dig Petitioner’s websites extremely heavily, often hundreds of pages
`
`a day for several hours a day from time to time from 12-20-2010 to 01-09-2011 with only calm
`
`holidays.
`
`(10) Petitioner sent a total of 9 e-mails to Registrant as shown in Attachment_14 (e-mails
`
`highlighted with check marks): 2010-11-19 ~ 2010-12-20.
`
`(11) The Petition for Cancellation was filed: 01-09-2011.
`
`Clearly, Petitioner was forced to file this Petition as a self-defense. Petitioner is a victim of the
`
`harassment and threatening by an international giant company. The Board, as a US government
`
`agency has the obligation to make laws to protect its own citizen, who is financially too weak to
`
`hire a lawyer. A giant international company is above the laws, based on its strong financial
`
`power, with a huge annual spending in abusing science/scientific literature and attacking US
`
`health care system for about 2 decades.
`
`
`
`10
`
`

`
`Petitioner trusts the Board to be fair in determining who had the legal fault at the first place,
`
`while the other party was forced to defend with frustration, even though making unintended
`
`errors.
`
`
`
`10. In summary, Petitioner respectfully requests that RESPONDANT’S MOTION FOR
`
`JUDGMENT ON THE PLEADINGS be dismissed, and this Petition for Cancellation be
`
`considered further.
`
`
`
`
`
`Signature:
`
`/Sengen Sun/
`
`Printed Name: Sengen Sun, PhD
`
`President
`
`Isotonic OPC Antioxidant, Inc.
`
`Mailing address: 8838 La Camesa Street, San Diego, CA 92129.
`
`E-mail: info@amerinutra.net
`
`Date: 2011-05-26.
`
`
`
`11
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
`
`
`Isotonic OPC Antioxidants, Inc.
`
`Petitioner,
`
`Cancellation No. 92053495
`
`vs.
`
`
`
`Horphag Research Management S. A.
`
`Registration No. 1769633
`
`Registrant.
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of the foregoing PETITIONER’S SUPPLEMENT TO
`
`ITS RESPONSE TO REGISTRANT’S MOTION FOR JUDGEMENT ON PLEADINGS, is being
`
`sent via USPS Express Mail to Addressee, postage prepaid, this 26th day of May, 2011, in an
`
`envelop addressed to Registrant’s legal counsel as follow:
`
`12
`
`MARVIN S. GITTES
`MINTZ LEVIN COHN FERRIS.....
`666 3RD AVE, FL 24
`CHRYSLER CENTER
`NEW YORK, NEW YORK 10017
`
`DATED, this 26th day of May, 2011,
`
`By: /Sengen Sun/
`
`Sengen Sun, PhD
`President
`Isotonic OPC Antioxidant, Inc.
`8838 La Camesa Street, San Diego, CA 92129.
`
`
`
`
`
`

`
`2008 > Herb Time 22-May-08
`
`Page 1 of 3
`
`Home> Inspections, Compliance, Enforcement, and Criminal Investigations> Enforcement Actions> Warning Letters
`
`Inspections, Compliance, Enforcement, and Criminal Investigations
`Herb Time 22-May-08
`
`Department of Health and Human Services
`
`
`
`
`VIA FEDERAL EXPRESS
`
`Karyl Sellinger
`Herb Time
`713 Saco Ct.
`St. Augustine, Florida 32086
`
`Dear Ms. Sellinger:
`
`Public Health Service
`Food and Drug Administration
`
`555 Winderley Pl., Ste. 200
`Maitland, Fl 32751
`
`WARNING LETTER
`
`FLA-08-17
`
`May 22, 2008
`
`This letter concerns your firm's marketing of C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream
`on your website, www.herbtime.com. According to information on this website, your products are intended to prevent, treat, or cure disease
`conditions or to affect the structure or function of the body.
`
`We note that you have attempted to disclaim some of the statements on your site that indicate that the products are intended to prevent, treat, or
`cure disease conditions or to affect the structure or function of the body. For example, your site says regarding C-Herb products:
`
`"Disclaimer: Consumer testimonials presented on our website are personal experiences for that individual and does [sic] not mean the same result
`will be achieved by others."
`
`"Nothing herein is intended to diagnose, treat or cure any specific disease."
`
`However, untrue or misleading information in one part of your site will not be mitigated by inclusion of such a "disclaimer." Cf. 21 C.F.R.202.1(e)(3)
`(i).
`
`Statements on your website that document these intended uses include, but are not limited to, the following:
`
`C-Herb
`
`• "A significant number of individuals have topically removed cancers, warts, moles and other foreign cells from various skin areas of the body. The
`removal success rate approaches 100%."
`
`• "C-Herb topical data demonstrates that it consistently and regularly removes skin cancers, moles and warts."
`
`• "Using some of the above mentioned herbs, my Mom got rid of a tumor in her left lung. [. . .] [T]he doctor detected a cancerous tumor in her left
`lung in February, 1993. [. . .] Well, I knew that C-Herb worked well on external moles, warts, but I hadn't used it internally up to this point. My
`personal friend and consultant, Wendell, told me that all my Mom needed was pycnogenol and C-Herb. Well, I muscle tested her and sure enough, all
`she needed was [sic] these two products. The C-Herb comes in 24 daily doses. Following only two months of treatments, she went back to the doctor
`and had her lung x-rayed and did a bone scan. The radiologist report was clean. They couldn't find a trace of cancer in her body."
`
`• "When the cancer came back after the last surgery I decided to have the area treated with C-Herb. The treatment went exactly as predicted. [. . .]
`On about the fifth day from the first treatment, the cancer came out as a core about the size of a pencil eraser."
`
`• "I was told by the doctors who did surgery for my colon and liver cancer that there was no hope and that I had less than 3 months to live at best.
`That was in 1991. I took the C-Herb and other supplements you suggested and saw amazing results within a short time, with the cancer appearing to
`be totally gone after several months."
`
`• "C-Herb - Hope for HIV [. . .] In the fall of 1992, a young man who had been diagnosed with the HIV virus two years previously, wasn't getting any
`positive results working with his medical doctor. [. . .] In January of 1993, he was diagnosed with TB. [. . .] By June of 1993 his breathing was much
`improved but still tested positive for TB and his T-cell count remained very low. [. . .] He tested strong for C-Herb, pycnogenol, and yarrow TincTract.
`The C-Herb is an old Indian remedy for viruses and other pathogens which has historically and is currently producing fantastic results across the
`United States. [. . .] After only one month on the program, he went back to his doctor for further testing, and his T-cell count had gone from 100 to
`212. It had more than doubled in one month's time. He also tested negative for TB. [. . .] The young man didn't tell [his doctor] that he hadn't taken
`any drugs for over a year, and that herbs were to be credited for the improvement. [. . .] He is still HIV positive but much stronger and possessing
`greater energy than he has in years. Who knows, if he continues the program, perhaps he can go from HIV positive to negative."
`
`C-4 Cream
`
`• "It doesn't 'pull them out' like C-herb does, but it often reduces them to a more manageable size. This formulation works with topical skin disorders
`that are too large to treat with C-Herb directly or for blisters like Herpes."
`
`• "Typically C-4 cream will reduce the size of the effected [sic] area. For example, a skin cancer might be the size of a quarter or even larger before
`applying C-4 cream as discussed previously. After a time the area may shrink to the size of a pencil eraser with this treatment."
`
`Eye Drops
`
`http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048283.htm
`
`2/19/2011
`
`

`
`2008 > Herb Time 22-May-08
`
`Page 2 of 3
`
`• "These eye-drops are a concentrated tincture made from C-Herb. They are designed for use on some types of cataracts, pink eye and other chronic
`eye problems."
`
`Eye/Ear Wash
`
`• "The wash is a diluted tincture made from C-Herb that is very helpful in working with eye or ear infections."
`
`Immune Max
`
`• "Inhibits pathogen growth, including cancers and viruses."
`
`• "Proven to help with shingles, arthritis, fibromyalgia, joint pain, AIDS and more"
`
`• "Promotes tissue repair and wound healing."
`
`Saw Palmetto Cream
`
`• "The truth is 25% of men as young as age 20 have been found to have precancerous conditions of the prostate. This condition is known, as benign
`prostatic hypertrophy, or BPH. Evidence suggests that one contributing factor of BPH is elevated levels of the highly active form of testosterone
`known as dihydrotestosterone (DHT). Increased levels of this hormone have been found in prostatic tissue of men with BPH.
`Of all the herbal preparations researched Saw Palmetto has been the most popular solution for BPH. It works by assisting in reducing the BPH by
`controlling or blocking the conversion of testosterone into its highly active form (5-a-reductase). Saw Palmetto also works as an anti-inflammatory
`herb, reducing the size of the prostate. Studies indicate that 320 mg. of Saw Palmetto per day greatly reduces painful urination, nocturia, and post-
`urination residue in the bladder, with significant improvement in urine, flow rate."
`
`• "In addition to the elevated count I had a significant amount of swelling and my doctor felt that both of these were indications that I was moving
`quickly towards prostate cancer. [. . .] My wife spoke with an alternative practitioner who told her about Saw Palmetto Cream. I began using that
`faithfully and within two weeks the symptoms began to lessen."
`
`Wild Yam Cream
`
`• "Many have had cysts and tumors, especially in breasts, disappear after just a few weeks of using the cream. Applying wild yam cream to the skin
`lets the progesterone precursors that are found in the Wild Yam extract, enter the body systemically while bypassing the liver."
`
`C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream are drugs, as defined by section 201(g)(1)
`of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation,
`treatment, or prevention of disease in man or other animals. Moreover, these products are new drugs, as defined by section 201(p) of the Act, 21
`U.S.C. § 321(p), because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act,
`21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved
`application is in effect for it. Your sale of the aforementioned products without approved applications violates these provisions of the Act.
`
`Furthermore, since C-Herb, C-4 Cream, Eye Drops, Eye/Ear Wash, Immune Max, Saw Palmetto Cream, and Wild Yam Cream are offered for
`conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be
`written so that a layman can use the products safely for their intended uses. Thus, your products' labeling fails to bear adequate directions for their
`intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
`
`The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your 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 assure that your firm complies with all requirements of federal law and FDA regulations. We
`advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you
`make for your products do not cause them to violate the Act.
`
`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. Other federal agencies may take this Warning Letter into account when
`considering the award of contracts.
`
`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. If
`you no longer manufacture or market the aforementioned products, your response should so indicate, including the reasons that, and the date on
`which, you ceased production. Additionally, if another firm manufactures the products identified above, your reply should include the name and
`address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in
`addition to the manufacturer.
`
`Please direct your response to the U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751, Attention: Shari H.
`Shambaugh, Compliance Officer.
`
`A description of the new drug approval process can be found on FDA's internet website at
`http://www.fda.gov/cder/regulatory/applications/default.htm 1. Any questions you may have regarding this process should be directed to the Food
`and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 10903 New Hampshire Ave., W051-
`2201, Silver Spring, MD 20993.
`
`Sincerely,
`
`/S/
`
`Emma R. Singleton
`Director, Florida District
`
`cc:
`Stephanie Newman & Karyl Sellinger
`Herbtime
`138 Palm Trail
`East Palatka, FL 32131
`
`Rebecca Poston
`Executive Director
`Florida Board of Pharmacy
`4052 Bald Cypress Way, Bin #C04
`Tallahassee, FL 32399-3254
`
`
`http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048283.htm
`
`2/19/2011
`
`

`
`2008 > Herb Time 22-May-08
`
`Page 3 of 3
`
`Links on this page:
`
`1.
`
`http://www.fda.gov/cder/regulatory/applications/default.htm
`
`http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048283.htm
`
`2