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  5. The Camel Milk Co. LLC dba Camel Culture - 611518 - 09/22/2021
  1. Warning Letters

WARNING LETTER

The Camel Milk Co. LLC dba Camel Culture MARCS-CMS 611518 —

Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Ryan Fee
Recipient Title
Owner
The Camel Milk Co. LLC dba Camel Culture

17032 Campo Drive
Parker, CO 80134
United States

Issuing Office:
Office of Human and Animal Foods Operations – Division West 4

United States

September 22, 2021

WARNING LETTER

Ref: # CMS 611518

Dear Mr. Fee:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://camelculture.org/ in July and August 2021 and has determined that you take orders there for the products Camel Milk (pint and liter) and Dry Camel Milk Powder. We have also reviewed your Facebook and Instagram social media websites at https://www.facebook.com/thecamelculture and https://www.instagram.com/camel.culture/, which direct consumers to your website https://camelculture.org/ to purchase your camel milk products. In addition, we observed that your Camel Milk and Dry Camel Milk Powder products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. The claims on your website and social media websites establish that the products are 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)] 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 can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

On https://camelculture.org/:

On the product pages for Camel Milk and Dry Camel Milk Powder:

  • Under the “Health Benefits” heading: “Higher than cows milk in … anti-inflammatories”

On the “Health Benefits” webpage:

  • “CAMEL MILK IS . . . High mineral and immunoglobulin content: Immunoglobulin is an antibody used by the immune system to identify and neutralize bacteria and viruses.”
  • “CAMEL MILK IS . . . Rich in protective proteins, mainly enzymes which exert antiviral, antifungal, antibacterial, and immunological properties… which are crucial in preventing food allergies and rehabilitating the immune system.”

On your homepage and Blog webpage, in the section that links to your blog post entitled “LACTOFERRIN: THE NATURAL VACCINE IN CAMEL MILK”:

  • “Lactoferrin . . . has anti-bacterial, anti-viral, anti-fungal, anti-inflammatory, anti-parasitic, and anti-carcinogenic properties! Studies show camel milk benefits are like a natural vaccine strengthening your immunity and even fighting diseases like COVID-19!”

On your July 22, 2021 blog post entitled “LACTOFERRIN: THE NATURAL VACCINE IN CAMEL MILK”

  • “Lactoferrin is one of the most dominant proteins in camel milk. . . . LACTOFERRIN FIGHTS COVID-19! . . . In one study . . . lactoferrin was proposed to be both a preventative and therapeutic supplement to the COVID-19 pandemic. . . . Finally, lactoferrin may also help prevent some of the later negative effects that an active COVID-19 infection plays on our bodies’ blood platelet counts.”

Examples of some of the social media website claims that provide evidence that your products are intended for use as drugs include:

On your Facebook social media website, https://www.facebook.com/thecamelculture:

  • On a February 17 post: “We are so thankful for people . . . who have been working tirelessly to Inspire [sic] parents with natural solutions to create the most fulfilling, healthy and productive life possible for their children with autism. The most recent episode is all about the intersection of the natural benefits of camel milk in this vital work . . . #naturalrecoveringautism #camelmilk #camelculture #autism . . . CHECK OUT NATURALLY RECOVERING AUTISM’S NEWEST EPISODE TO HEAR ABOUT THE NATURAL BENEFITS OF CAMEL MILK!”
  • On a December 10, 2020 post with an image of your Camel Milk product : “HIGH MINERAL & IMMUNOGLOBULIN CONTENT: IMMUNOGLOBULIN IS AN ANTI-BODY USED BY THE IMMUNE SYSTEM TO IDENTIFY AND NEUTRALIZE BACTERIA AND VIRUSES.”
  • On a December 17, 2020 post: “Camel Milk is nutritious with some very specific health benefits . . . HIGH IN ANTI-INFLAMMATORIES”
  • On a February 4 post with an image of your Camel Milk product: “HIGH IN ANTIINFLAMMATORIES”

On your Instagram social media website, https://www.instagram.com/camel.culture/:

  • On a December 10, 2020 post with of an image of your Camel Milk product: “HIGH MINERAL & IMMUNOGLOBULIN CONTENT: IMMUNOGLOBULIN IS AN ANTI-BODY USED BY THE IMMUNE SYSTEM TO IDENTIFY AND NEUTRALIZE BACTERIA AND VIRUSES.”
  • On a February 4, 2021 with an image of your Camel Milk product: “HIGH IN ANTIINFLAMMATORIES”
  • On a February 12, 2021 post: “CAMEL MILK . . . Higher in Anti-Inflammatories”
  • On a February 17, 2021 post: “We are so thankful for people . . . who have been working tirelessly to Inspire [sic] parents with natural solutions to create the most fulfilling, healthy and productive life possible for their children with autism. The most recent episode is all about the intersection of the natural benefits of camel milk in this vital work . . . CHECK OUT NATURALLY RECOVERING AUTISM’S NEWEST EPISODE TO HEAR ABOUT THE NATURAL BENEFITS OF CAMEL MILK!”
  • On December 17, 2020 post: “Camel milk is nutritious with some very specific health benefits . . . HIGH IN ANTI-INFLAMMATORIES”
  • On a May 9, 2020 post: “Others have shared that Camel Milk has helped their natural ability to fight illness.”
  • On a story in your “Health” story highlights: “Lactoferrin, a naturally occurring iron-binding protein, is an antioxidant that protects against infections. It provides antibacterial, antiviral, antifungal, anticancer, antioxidant, anti-inflammatory agents. . . . Camel milk contains up to 10x higher volume of lactoferrin than cow’s milk.”

Your websites also contain evidence of intended use in the form of personal testimonials recommending or describing the use of Camel Milk and Dry Camel Milk Powder for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

On your website homepage, https://camelculture.org:

  • LAHOMA M.: “We were desperate! Our baby had severe reflux, and a friend recommended Camel Milk…. After his 1st camel milk bottle, and he has not had acid reflux since!”

On your website product page for Dry Camel Milk Powder, https://camelculture.org/products/drycamel-milk-powder:

  • MR. SAMEER: “Cures diarrhea.”

On your Facebook social media website, https://www.facebook.com/thecamelculture:

  • On a December 27, 2020 post: “My daughter is suffering from autism. I started giving her camel milk and now she is showing really good signs. She is sleeping well and her digestion is greatly improved! Camel milk is truly helping my lovely daughter.”

On your Instagram social media website, https://www.instagram.com/camel.culture/:

  • On an August 9, 2020 post: “I HAVE SEEN SO MANY POSITIVE CHANGES IN MY SON AFTER HE STARTED DRINKING CAMEL MILK. HIS RASHES ARE DECREASED!”
  • On an October 25, 2020 post and a December 27, 2020 post: “MY DAUGHTER IS SUFFERING FROM AUTISM. I STARTED GIVING HER CAMEL MILK AND NOW SHE IS SHOWING REALLY GOOD SIGNS. SHE IS SLEEPING WELL AND HER DIGESTION IS GREATLY IMPROVED! CAMEL MILK IS TRULY HELPING MY LOVELY DAUGHTER.”

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 FD&C Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C 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)(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 products Camel Milk and Dry Camel Milk Powder 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, Camel Milk and Dry Camel Milk Powder fail to bear adequate directions for their intended use and, therefore, the products are 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Kathy Tormey, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at Kathleen.tormey@fda.hhs.gov or (303) 236-3137 if you have any questions about this matter.

Sincerely,
/S/

E. Mark Harris
Denver District Director & Program Division Director
Office of Human and Animal Foods Operations –
Division West 4

____________________________

1 There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novelcoronavirus-disease-covid-19-outbreak/. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

 
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