- Celloxess LLC
- Issuing Office:
- New Jersey District Office
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
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July 22, 2016
VIA UNITED PARCEL SERVICE
Attn: Dr.Parviz Gharagozloo
15 Roszel Road
Princeton, NJ 08540
Dear Dr. Parviz Gharagozloo:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses
www.celloxess.com and www.fertilix.com in July 2016 and has determined that you take orders there for the products, Fertilix® Preconceptual, Fertilix®Low Dose, and Fertilix®Max. The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act
(the Act) [21
321(g)(1)(B)] because they are intended for use in the cure, mitigation,
treatment, or prevention of disease. As explained further below, introduction or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA'shome page at www.fda.gov.
Examples of some of the claims observed on your websites that provide evidence that your products are intended for use as drugs include the following:
On the home page:
• "Pioneering Disease Prevention The Natural Way"
On the webpage, "Oxidative Stress & Male Infertility":
• "Sperm Oxidative Stress is now recognized as one of the central features of testicular dysfunction and in the aetiology of defective sperm function ... Pregnancies obtained with damaged sperm DNA will carry elevated risk of miscarriage and/or may lead to embryonic DNA mutations with unpredictable consequences in the health of the offspring ...Based on extensive research, CellOxess now offers FERTILIX™, a ...supplement to combat sperm oxidative stress"
On the webpage, "Treatment":
• "A 3 month course of therapy with Fertilix will emich the number of quality sperm cells in the semen, increasing the chances of a healthy pregnancy and offspring."
On the home page:
• "[P]rotect sperm cells from routine oxidative damage. optimizing chance of conception, a successful pregnancy, and healthy offspring"
On the webpage, "Male Fertility: General Facts":
• "[O]xidativestress could case DNA damage without appearing to affect sperm quality as assessed by a routine semen analysis"
Furthermore, claims made on your Facebook pages, www.facebook.com/CellOxess and www.facebook.com/fertilix, which includes links to your website, www.fertilix.com, where products can be purchased directly, prov-ideadditional evidence that your products are intended for use as drugs:
Posts by your company on your Facebook pages include the following:
• On July 24, 2015: "Treat oxidative stress to avoid disease... Oxidative stress is implicated in cancer, alzheimer's, MS, and infertility... Before disease, there is predisease. Celloxess is actively pursuing new methods of treatment."
• On your Fertilix Facebook page on June 13, 2015: "CellOxess is ...dedicated to disease prevention through the diagnosis and treatment of Chronic Cell Oxidative Stress"
We also note that FDA collected promotional material for your product at the 2016 Natural Products Expo West trade show that was held on March 9-13, 2016 at the Anaheim Convention Center. This promotional material includes the website addresses, www.celloxess.com and www.fertilix.com, where your products can be purchased directly. Claims included in the promotional literature provide evidence that your products are intended for use as drugs:
On the "FERTILIX™ Preconceptual Antioxidant" literature:
• "Oxidative stress lowers male fertility potential"
• "Oxidative stress affects semen parameters and DNA integrity"
• "Sperm oxidative stress may increase DNA mutations passed on to children"
• "Oxidative stress is now recognized as a serious male fertility factor adversely affecting semen quality. It damages sperm molecular components such as DNA ... The collateral damage reduces sperm fertilizing potential, compromises pregnancy and may result in the transmission of altered paternal DNA."
• "Fertilix™ ... protect against oxidative damage to sperm DNA and/or membranes in human clinical trials."
On the "Fertilix® Advantage FACT SHEET" literature:
• "Sperm Oxidative Stress (SOS) is now recognized as a key male fertility factor. Such damage to ...DNA integrity ...in turnleads to reduced male fertility, increased miscarriage rates and de novo mutations in future generations. Approximately 60% of men seeking assisted conception are reported to have moderate to severe sperm oxidative DNA damage ... In vivo preclinical experiments confirm Fertilix® efficacy in reducing Sperm DNA Damage."
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are "new drugs" 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 describedin sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(l)of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). "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). Prescription drugs, as defined in section 503(b)(l)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products, Fertilix® Preconceptual, Fertilix®Low Dose, and Fertilix®Max, are intended for treatment of one or more diseases that are not amenable to self-diagnosisor treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequatedirections for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(l) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 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 violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulationsenforced 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 fifteen (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 the U.S. Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054 (re: CMS #495253). If you have any questions about the contents of this letter, please contact Charles J.Chacko, Compliance Officer, at 1-973-331-4946 (phone) or 1-973-331-4969 (fax).
Acting District Director
New Jersey District