Original Living Coconut, LLC - 561493 - 10/10/2018

WARNING LETTER

October 10, 2018

VIA UNITED PARCEL SERVICE
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED

Ms. Renee E. Ainlay
Original Living Coconut LLC
817 W. Arnold Wallen Way
Stockton, MO 65785

Reference CMS Case# 561493

Dear Ms. Ainlay:

On January 2, 2018, January 4, 2018 and January 8, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 817 W. Arnold Wallen Way, Stockton, MO. We collected product labels during the inspection for products you manufacture and distribute, including “Coconut Cream Dessert” (flavors including Vanilla Bean, Chocolate, Sugar Free Vanilla Bean, Salted Caramel, Lemon Crème, Cinnamon Roll, Caramel Mocha Latte, Sugar Free Chocolate), “Raw Coconut Cream” (flavors including Lime and Honey, Chocolate), and “Virgin Cold- pressed Coconut Oil.” We also printed screenshots from your website at the Internet address http://www.originallivingcoconut.com/ and discussed concerns about potential disease claims on your website. Your website was again reviewed on or about August 14, 2018, and it was determined that you take orders there for your products. The claims on your product labeling, including your website, establish that your firm’s 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 Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website and other product labeling claims that provide evidence that your Coconut Cream Dessert, Raw Coconut Cream, and Virgin Cold-pressed Coconut Oil products are intended for use as drugs include:

Coconut Cream Dessert (Vanilla Bean) product label

“Over a 14 year period [Renee] was diagnosed and struggled with a kidney disease that produced stones, diabetes, high blood pressure, spinal meningitis and more. Never giving up hope, her husband John brought Renee to a well-known Doctor who prescribed food as her medicine, with raw coconut cream being a main staple. Renee attributes a large amount of her recovery to the consumption of raw coconut cream which helped heal her digestion so her body could finally receive the vital nourishment she so greatly needed. Since regaining her health in 2007, Renee was the first in developing Original Living Coconut’s Raw Coconut Cream and perfecting way to make it widely available to the public so others can benefit from this miracle food.”
“It also contains antimicrobial healing properties helping to support overall immune system functions.”

Website – www.originallivingcoconut.com

From the Coconut Research page:

“In traditional medicine around the world coconut is used to treat a wide variety of health problems including the following: abscesses, asthma, baldness, bronchitis, bruises, burns, colds, constipation, cough, dropsy, dysentery, earache, fever, flu, gingivitis, gonorrhea, … jaundice, kidney stones, lice, … rash, scabies, scurvy, skin infections, sore throat, swelling, syphilis, toothache, tuberculosis, tumors, typhoid, ulcers, upset stomach, … and wounds.”
“Published studies in medical journals show that coconut, in one form or another, may provide a wide range of health benefits. Some of these are summarized below:
- “Kills viruses that cause influenza, herpes, measles, hepatitis C, SARS, AIDS, and other illness.
- “Kills bacteria that cause ulcers, throat infections, urinary tract infections, gum disease and cavities, pneumonia, and gonorrhea, and other diseases.
- “Kills fungi and yeasts that cause candidiasis, ringworm, athlete’s foot, thrush, diaper rash, and other infections.
- “Expels or kills tapeworms, lice, giardia, and other parasites.
- “Reduces symptoms associated with pancreatitis.
- “Helps relieve symptoms and reduce health risks associated with diabetes.
- “Reduces problems associated with malabsorption syndrome and cystic fibrosis.
- “Helps protect against osteoporosis.
- “Helps relieve symptoms associated with gallbladder disease.
- “Relives symptoms associated with Crohn’s disease, ulcerative colitis, and stomach ulcers.
- “Relieves pain and irritation caused by hemorrhoids.
- “Reduces inflammation.
- “Supports tissue healing and repair.
- “Helps protect the body from breast, colon, and other cancers.
- “. . . improves cholesterol ratio reducing risk of heart disease;
- “Protects arteries from injury that causes atherosclerosis and thus protects against heart disease.
- “Helps prevent periodontal disease and tooth decay.
- “Helps to protect the body from harmful free radicals that promote…degenerative disease.
- “Helps relieve symptoms associated with chronic fatigue syndrome.
- “Relieves symptoms associated with benign prostatic hyperplasia (prostate enlargement).
- “Reduces epileptic seizures.
- “Helps protect against kidney disease and bladder infections.
- “Dissolves kidney stones.
- “Helps prevent liver disease.
- “Helps prevent obesity and overweight problems.
- “Applied topically helps to form a chemical barrier on the skin to ward of [sic] infection.
- “Reduces symptoms associated the [sic] psoriasis, eczema, and dermatitis.
- “Provides protection from damaging effects of ultraviolet radiation form [sic] the sun.
- “Helps control dandruff.”

From the Health Benefits of Coconut Cream page:
• “[Coconut Cream] is the most powerful solvent for breaking up stored hardening in the body such as stored plaque due to cooked facts, cooked cholesterol and medications. This is crucial. Plaque hardening of the arteries, nerve endings, brain and lymph (just to name a few areas) is one of the most difficult stored toxins to remove. Coconut cream will do this.”

From the Coconut Oil and Babies page:
• “The unique composition of human breast milk includes the fatty acid, lauric acid and capric acid, which have potent antimicrobial properties. These fatty acids offer the nursing infant protection from viruses such as herpes and HIV, protozoa such as giardia lamblia, and bacteria such as chlamydia and heliocobater. A study published in 1998 in the American Journal of Clinical Nutrition has shown that lactating mothers who eat coconut oil and other coconut products have significantly increased levels of lauric acid and capric acid in their breast milk. Thus, the milk supply has increased amounts of the protective antimicrobials, which will give even greater protection to the nursing infant.”

From the Coconut Oil page:
• “[Medium Chain Fatty Acids (MCFA)] help to lower the risk of both atherosclerosis and heart disease. It is primarily due to the MCFA in coconut oil that makes it so special and so beneficial.”

From the Coconut Oil and Fighting Diabetes page:
• “[C]oconut oil can help with how we deal with Diabetes.… The coconut oil acts as a blood sugar regulator acting in as little as 30 minutes to bring blood sugar levels back done [sic] to appropriate levels.”

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 FDA, as described in 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)(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 Coconut Cream Dessert, Raw Coconut Cream, and Virgin Cold-pressed Coconut Oil 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 use for a layperson to use your firm’s products safely for their intended purposes. Accordingly, your firm’s products 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 of section 301(a) of the Act [21 U.S.C. § 331(a)].

This letter is not an all-inclusive statement of violations associated with your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.

You should take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

If you need additional information or have questions, please contact the FDA. You may respond in writing to Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration at 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about the contents of this letter, please contact Compliance Officer Hoopes at andrew.hoopes@fda.hhs.gov or 515-244-0480 ext. 1002.

Sincerely,
/S/
Cheryl A. Bigham
Program Division Director
Office of Human and Animal Food, West Division II