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:

On the webpage, “Around the World”:
On the webpage, “Science & Research”:
On the webpage, “Blog/News”:
 
Under the headline – “Camel Milk in Diabetics:”
Under the headline – “Health Benefits of Drinking Camel Milk ǀ desertfarms.com”:
 
Under the subheading, “Autism:”
Under the subheading, “Allergies”:
Under the subheading, “Immune:”
Under the headline, “Folate in Camel Milk can make a real difference:”
Under the headline – “Camel’s Milk and its potential for Alzheimer’s control:”
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:
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:
On June 24, 2016, a post which states the following:
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

This page was posted on March 28, 2019.

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