Warning letter · FDA Warning Letters, Historical Archive

Capris Associates Inc./BR Naturals: FDA Warning Letter 566245 (Feb 5, 2019)

Agency action: Feb 5, 2019Record ID: fda_warning_-a2b5b53a2ebc34d0
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What happened

Original notice title

Capris Associates Inc. / BR Naturals MARCS-CMS 566245, February 05, 2019

From the archived source record

Monolaurin … was proven to help the immune system fight harmful viruses and bacteria (herpes, cytomegalovirus, influenza, HIV).” Additional examples of some of the claims and personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease that appear on your blog at www.brnaturals.blog include the following: On the blog page titled “Alzheimer’s & Coconut Oil: Superfood for the Brain”: “[Dr.] Mary Newport has much reason to celebrate these days. Newport began an intensive feeding program for her husband that consisted of a mixture of 2 TBL virgin coconut oil and the MCT pharmaceutical isolate with every meal . … Within 35 days, Steve Newport’s rapid neurological decline was arrested and 18 months later he had recovered enough brain function and normal behavior to test as only a mild case of Alzheimer’s – the same tests which, before the starting the VCO feeding program, had indicated that he was borderline severe dementia. … Dr. [Mary] Newport now travels all over the United States relaying the remarkable story of her husband’s recovery from borderline severe dementia using VCO to essentially rebuild his brain. Both lauric acid and monolaurin can kill harmful pathogens like bacteria, viruses and fungi…. 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). Accordingly, Avocado Oil, Black Seed Oil, Moringa Powder, Premium Olive Oil D.O.P., Pumpkin Seed Oil, and Unrefined Coconut Oil 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)].

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
Historical warning letter; closeout not established by annual index
Source checked
Jul 16, 2026
Record revision
c6aab7620c4d

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Avocado Oil; Black Seed Oil; Moringa Powder; Premium Olive Oil D
Company
Capris Associates Inc./BR Naturals
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.