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Enforcement Actions

Herbal Papaya 8/12/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

August 12, 2013
 
2013-DAL-WL-045
 
WARNING LETTER
 
 
UPS OVERNIGHT
 
 
Unoma I. Okorafor, Ph.D.
Herbal Papaya, LLC
524 Shadow Rock Dr
Murphy, TX 75094-4186
 
 
Dear Dr. Okorafor:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.herbalpapaya.com in July 2013 and has determined that you take orders there for the products “Papaya Seed Extract”, “100% Papaya Leaf (Paw Paw Twig)”, “and “Papaya Leaf with Rooibos Tea”, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the claims on your website, www.herbalpapaya.com, that provide evidence that your products are intended for use as drugs include:
 
On the page entitled “Papaya Seed Extract – 60 Veggie Capsules”:
 
  • “Papaya seeds eliminate intestinal parasites … ”
  • “Papaya seeds have anti bacterial properties.”
 
On the page entitled “100% Papaya Leaf (Paw Paw Twig) – Dried, Cut and Sifted, 1LB”:
 
  •  “Papaya leaves have traditionally been used to … aid with malaria and dengue fever.”
 
On the page entitled “Papaya Leaf with Rooibos Tea – 24 Teabags”:
 
  • “[Q]uercetin [in Rooibos, an ingredient in your product] … helps to reduce the risk of various types of cancers [and] fights viruses.”
  • “Aspalathin [in Rooibos, an ingredient in your product] ... helps to regulate blood sugar and therefore can play a role in reducing the risk of Type 2 diabetes … ”
  • “The antioxidant nothofagin [in Rooibos, an ingredient in your product]…along with aspalatin … may help to reduce the risk of Alzheimer’s disease.”
 
Examples of some of the additional claims on your website that provide evidence that your products are intended for use as drugs include the following:
 
On the home page:
 
  • “[P]apaya leaf extract … fight[s] virus & infections … ”
  • “Papaya Leaf …exhibits anti-tumor effects.”
 
In your August 28. 2012 blog post “Papaya And Evans Syndrome”:
 
  • “Papaya leaf extract may be a natural remedy for Evans Syndrome … ”
 
You provide links from your homepage www.herbalpapaya.com to videos that include the following claims that provide evidence that your products are intended for use as drugs:
 
On the “Herbal Papaya Extract & Tea May Help Cancer, platelet blood count” video accessible at: www.youtube.com/watch?v=sRt23Ce_EOc:
 
  •  “Papaya leaf tea may treat cancer better than chemotherapy… ” (Text at 0:06)
  • “[R]ecent clinical studies have found that papaya leaf tea may help treat cancer … ” (0:07)
  • “Papaya leaf contains a rich source of papaya and antioixidants that … fight cancer … ” (0:18)
 
Your Facebook account accessible at: https://www.facebook.com/HerbalPapaya, which includes a link to your website at www.herbalpapaya.com, also includes evidence that your products are intended for use as drugs. The following are examples of the claims in the “About” section:
 
  •  “Herbal Papaya makes Papaya leaf (Pawpaw Twig), Seed and Fruit preparations to treat yourself naturally. … treat cancer … and hepatitis. ”
 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment or prevention of disease. Examples of such testimonials include:
 
On the “Testimonials” webpage:
 
You provide a link to the “ABC7 News” website that includes the following claim:
 
  • “Papaya tea may treat cancer better than Chemo”
 
You provide a link to the “Science Daily” website that includes the following claim:
 
  • “Papaya Extract Thwarts Growth of Tumors in Lab Tests”
 
You provide a link to “Barry’s testimonial – increase Platelet Count, Prednisone and Steroids Alternative” video. The testimonial states,
 
  • “When I was 7, I was diagnosed with low platelet count… which means I had ITP [Idiopathic Thrombocytopenic Purpura]… recently I’ve been using an herbal solution, herbal treatment and what that herbal treatment is, is herbal papaya … I went onto herbalpapaya.com and bought the herbal extract. … I feel 100% now. ” (0:13 – 0:48)
 
Moreover, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of publications that are used to market your products for disease treatment and prevention on your website and are thus evidence of your products’ intended use as a drug:
 
On the “FAQ” webpage”:
 
Under “Do you have clinical studies to support Papaya Leaf Products”:
 
  • “University of Florida researcher[s] … documented papaya’s dramatic anticancer effect against a broad range of lab-grown tumors, including cancers of the cervix, breast, liver, lung and pancreas. The scientists used an extract made from dried papaya leaves, and the anticancer effects were strong when cells received larger doses of the tea.”
 
Under the title “Is there any scientific research around Papaya Leaf?”:
 
  • Otsuki N, Dang NH, Kumagai E, et al., Aqueous extract of Carica papaya leaves exhibits anti-tumor activity and immunomodulatory effects. J Ethnopharmacol. Feb 17 2010; 12(3): 760-767.
  • Ahmad N, Fazal H, Ayaz M, et al., Dengue fever treatment with Carica papaya leaves extracts. Asian Pacific Journal of Tropical Biomedicine. 2011: 330-333.
  • Rahman S, Imran M, Muhammad N, et al., Antibacetial screening of leaves and stem of Carica papaya. Journal of Medicinal Plants Research. 2011; 5(2): 5167-5171.
  • Indran M, Mahmood AA, Kuppusamy UR., Protective effect of Carica papaya L leaf extract against alcohol induced acute gastric damage and blood oxidative stress in rats. West Indian Med J. Sep 2008; 57(4): 323-326.
 
The claims above are supplemented by the meta tags used to bring consumers to your website through Internet searches. Examples of meta tags targeted to consumers who are looking for products to prevent or treat various diseases include:
 
  • “Papaya Leaf Tea treat Cancer”
 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, this products are a “new drug” 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 described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Furthermore, your products 100% Papaya Leaf (Paw Paw Twig) and Papaya Leaf with Rooibos Tea, are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for its intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of 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 deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced 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 web site, please contact FDA. You may respond in writing to Seri Essary, Compliance Officer, at the above letterhead address. If you have any questions concerning this letter, please contact Ms. Essary at (214)253-5335.
 
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director