Inspections, Compliance, Enforcement, and Criminal Investigations

Desert Farms 9/15/16

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 15, 2016                                                                                            
WL #47-16 
Desert Farms
Attn: Mr. Walid Abdul-Wahab
2708 Wilshire Blvd. #380
Santa Monica, CA 90403
 
Dear Mr. Abdul-Wahab:                                                                                            
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet addresshttp://www.desertfarms.com in June 2016 and has determined that you take orders there for various camel milk products, including Raw Camel Milk (Fresh); Raw Camel Milk (Frozen); Raw Camel Milk Kefir (Fresh); Raw Camel Milk Kefir (Frozen); Pasteurized Camel Milk (Fresh); Pasteurized Camel Milk (Frozen); and Raw Camel Milk 1st Colostrum (Frozen); Raw Camel Milk Regular Colostrum (Frozen); Camel Milk Powder; Camel Milk Soap (assorted scents) which are promoted 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)(B)]. In addition, FDA reviewed your Facebook page at the Internet address www.facebook.com/desertfarms in June 2016, which has a link to the above-referenced website where products can be purchased directly.  The therapeutic claims on your website and Facebook page 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. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the claims on your website www.desertfarms.com and Facebook page that provide evidence that your product is intended for use as a drug include:

On the home page of www.desertfarms.com:
  • “[B]enefits of camel milk is now being embraced by health-conscious consumers, children with autism & people with diabetes.” 
On the webpage, “Around the World”:
  • “Early US demand for camel milk came from mothers of children with autism. Other people began using camel milk for autism…” 
On the webpage, “Science & Research”:
  • “Camel milk has been found to lower high fasting blood glucose levels and Hemoglobin A1c in diabetics.”
  • “Autistic children may benefit from camel milk”
  • “Camel whey may enhance diabetic wound healing”
  • “[I]t helps in diseases such as tuberculosis, diabetes…” 
On the webpage, “Blog/News”:
 
Under the headline – “Camel Milk in Diabetics:”
  • “[M]any studies on the benefits of camel milk in diabetics. Analysis has showed that camel’s milk has insulin like substances that may improve the glycemic (sugar) control in diabetics.” 
Under the headline – “Health Benefits of Drinking Camel Milk ǀ desertfarms.com”:
 
Under the subheading, “Autism:”
  • “[C]amel milk proponents believe that camel milk might benefit people with autism. A study published in the 2005 edition of the “International Journal of Human Development” observed the effects of camel milk consumption, instead of cow milk, on autistic people. Researchers discovered that after a 4-year-old female participant drank camel milk for 40 days, her autism symptoms disappeared. A 15-year-old boy also recovered after 30 days of drinking the milk…Though the milk is believed beneficial, insufficient scientific evidence exists to prove the effectiveness of it in the treatment of autism.” 
Under the subheading, “Allergies”:
  • “A study published in the December 2005 edition of the “Israel Medical Association Journal” investigated the effects of camel milk on eight children with severe milk and other food allergies. After failing to respond to conventional treatments, study participants consumed camel milk under the direction of researchers…all eight children fully recovered from their allergies with no side effects…researchers stated that results were spectacular when compared with traditional treatments. Disease-fighting immunoglobulins in camel milk were believed to play a key role in reducing allergic symptoms; however, additional scientific research is needed to sufficiently prove the effectiveness of camel milk in treating allergies.”
Under the subheading, “Immune:”
  • “The potent immune-system components in camel milk might help fight diseases…People with autoimmune system disorders, such as Crohn’s disease and multiple sclerosis, have immune systems that attack their own body tissues. Although traditional treatments for autoimmune disorders suppress the immune system, camel milk benefits these disorders by boosting it, according to Israeli physiology professor emeritus Dr. Reuven Yagil. Despite conventional wisdom, Yagil asserts that his observations over a five-year period indicate that camel milk can control or even heal autoimmune disorders, but insufficient scientific evidence exists to prove the effectiveness of camel milk in the treatment of autoimmune diseases.”
Under the headline, “Folate in Camel Milk can make a real difference:”
  • The Camel milk has enough folates to prevent other diseases that are related to folate deficiency, like Pediatric Chron’s [sic] disease, periodontal disease, mucosal candidiasis etc. Camel milk will also prevent blood diseases like macrocytosis, thrombocytopenia and megaloblastic anemia. All these are blood diseases that can be prevented by the adequate intake of folates…Another benefit of folate in camel milk is related to the attention disorders and neurologic deficiencies.” 
Under the headline – “Camel’s Milk and its potential for Alzheimer’s control:”
  • “Recent studies are beginning to show that Camel Milk may have benefits in halting the progression of Dementias such as Alzheimer’s… The camel milk could also potentially benefit other brain degenerative diseases such as Parkinson’s and autism.”
The website, www.desertfarms.com, also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your camel milk products for the cure, mitigation, treatment, or prevention of disease. Examples of the testimonials include:
  • “Seems to be working on parasites.
  • “My autistic child is sleeping more and has had improvement in his behavior and social skills”
  • “It is working wonders on my skin (eczema)…”
  • “My son [sic] eczema is improving with the camel milk, too.”
Further, claims made on your Facebook page, www.facebook.com/desertfarms, which includes a link to www.desertfarms.com where your products can be purchased directly, provide additional evidence that your camel milk products are intended for use as drugs: 
 
On April 3, 2016, a post which included a link to an article titled, “Camel Milk: How This Secret Middle Eastern Drink is Healing the World” which states the following:
  •  “MANY HAVE TOUTED ABOUT CAMEL MILK’S ANTIBACTERIAL, ANTIVIRAL AND ANTITUMOR PROPERTIES THAT HAS LED TO TESTIMONIALS FROM THOSE WHO HAVE SHOWN MAJOR IMPROVEMENTS FROM CANCER, DIABETES, AUTISM, AUTOIMMUNE DISORDERS…”
  • “[T]op 4 Benefits…Diabetes…Cancer…Autism…Allergies…”
On June 24, 2016, a post which states the following:
  • “Camel milk soap is super good for skin problems like eczema, psoriasis, allergies . . . etc.” 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 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. 
 
A drug is misbranded under section 502(f)(1) 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)(1)(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 Raw Camel Milk (Fresh); Raw Camel Milk (Frozen); Raw Camel Milk Kefir (Fresh); Raw Camel Milk Kefir (Frozen); Pasteurized Camel Milk (Fresh); Pasteurized Camel Milk (Frozen); and Raw Camel Milk 1st Colostrum (Frozen); Raw Camel Milk Regular Colostrum (Frozen); Camel Milk Powder; Camel Milk Soap (assorted scents) products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Raw Camel Milk (Fresh); Raw Camel Milk (Frozen); Raw Camel Milk Kefir (Fresh); Raw Camel Milk Kefir (Frozen); Pasteurized Camel Milk (Fresh); Pasteurized Camel Milk (Frozen); and Raw Camel Milk 1st Colostrum (Frozen); Raw Camel Milk Regular Colostrum (Frozen); Camel Milk Powder; Camel Milk Soap (assorted scents) products fail to bear adequate directions for their intended use and, therefore, the products misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of the misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. 
 
The violations cited in this letter are not intended to be an all-inclusive list 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 ensure that all products marketed by your firm comply with the Act and its implementing regulations.
 
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/or injunction. 
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete corrective action within fifteen working days, please explain the reason for the delay and the date by which you will make the correction.
 
Please send your written response to:
 
Kelly Sheppard
Director, Compliance Branch
Food & Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. If you have any questions about the contents of this letter, please contact Daniel W. Cline, Compliance Officer at 949-608-4433 or Daniel.Cline@fda.hhs.gov.
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Director, Los Angeles District
  
 
cc:
Mr. Walid Abdul-Wahab
550 N. Figueroa St.
#5099
Los Angeles, CA 90012
 

 

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