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  5. New Spirit Naturals Inc. - 595025 - 05/07/2020
  1. Warning Letters

WARNING LETTER

New Spirit Naturals Inc. MARCS-CMS 595025 —


Delivery Method:
United Parcel Service
Product:
Drugs

Recipient:
Recipient Name
Dr. Larry J. Milan
Recipient Title
President & CEO
New Spirit Naturals Inc.

615 W. Allen Ave.
San Dimas, CA 91773-1447
United States

Issuing Office:
Division of Human and Animal Food Operations West V

United States


WARNING LETTER

May 7, 2020


WL #595025


Dear Dr. Milan:

This is to advise you that the Food and Drug Adminstration (FDA) reviewed your website at the Internet address www.newspirit.com in April 2020 and has determined that you take orders there for the products PolyMeal Body Fuel, Cardioplex, Super Curcumin Complex with Boswellia, CoQ-10 & Cinnamon, and Colloidal Silver. The claims on your website establish that your PolyMeal Body Fuel, Cardioplex, Super Curcumin, Co-Q10 & Cinnamon, and Colloidal Silver products are drugs under section 201(g)(1)(B) of 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 the FDA’s home page at http://www.fda.gov.

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

PolyMeal Body Fuel

From your product catalog (which can be accessed from your website):

• "The Polymeal concept originated as a diet-based approach to combatting heart disease . . .. [A] group of researchers isolated six key foods (red wine, dark chocolate, garlic, omega-3, fruits, vegetables and raw almonds) that studies have consistently shown to reduce the risk of heart disease by approximately 76% and increase life expectancy — up to 6.6 years in men and 4.8 years in women! These six foods became known as the “Polymeal.”

Cardioplex

From your newsletter from summer 2015 (which can be accessed from your website), on a page showing an image of your Cardioplex:

• "Researchers indicate that women with higher folate and folic acid intakes had a significantly lower frequency of migraine attacks . . ..”

From your website description and online sale page for Cardioplex:

• "Research is conclusive that cardiovascular disease can be avoided with a healthy lifestyle and the addition of nutritional supplements that reduce risk factors including high blood pressure, high cholesterol and triglycerides . . .."

Super Curcumin Complex with Boswellia

From your newsletter from fall 2014 (which can be accessed from your website), on a page showing an image of your Super Curcumin Complex with Boswellia:

• "Inflammation is the body's first defense against infection. When it goes awry, it can lead to heart disease, cancer, arthritic conditions, Alzheimer's, and a host of other diseases. New studies have tied inflammation to over-expression of a protein molecule called Nuclear-Factor∙Kappa B (NFKB). . . . [Curcumin] inhibits over-expression of NFKB . . ..”

• "The major use of boswellia today has been in the area of inflammatory conditions. Many diseases and physical trauma induce inflammatory reactions. While inflammation is a necessary component of the body's immune response, it can lead to chronic conditions such as arthritis, heart disease, cancer, Alzheimer's, hepatitis, and a host of other diseases . . .."

From your product catalog (which can be accessed from your website):

• "Helps suppress pro-inflammatory enzymes."

• "Reduce inflammation naturally with time tested plant based ingredients that have been shown in clinical studies to reduce painful inflammation and help prevent the associated destruction of supportive tissue that can lead to joint disfigurement and limited mobility."

From your website product description and online sale page for Super Curcumin Complex with Boswellia:

• "Reduce inflammation naturally with a time tested Ayurvedic combination of Curcumin longa and Boswellia serrata. Science now recognizes inflammation as the body’s first immune reaction against injury and infection. While this response is essential for healing, as we age, the body’s regulatory control mechanisms often breakdown [sic], igniting degenerative inflammatory conditions, including arthritis, colitis and atherosclerosis."

• "Helps suppress pro-inflammatory enzymes."

• "Reduce inflammation naturally"

CoQ-10 & Cinnamon

From your newsletter from summer 2015 (which can be accessed from your website), on a page showing an image of your CoQ-10 & Cinnamon:

• "Did you know that cinnamon...protects against heart disease...reduces LDL cholesterol levels...can be effective against ulcer-causing H. pylori bacteria...may reduce the pain linked to arthritis...may reduce the proliferation of cancer cells…"

Colloidal Silver

From your website product description and online sale page for Colloidal Silver:

• “Can be applied topically to skin as a disinfectant.”

• “Silver is a natural component of our immune system, acting in concert with the immune system to prevent the proliferation of pathogenic bacteria, viruses, and fungi.”

From your product catalog (which can be accessed from your website):

• “Powerful tool when fighting the common cold.”

• “For hundreds of years, silver has been known as a natural antibiotic agent. Numerous studies have shown it to support our immune system by assisting to minimize the spreading of bacteria, viruses, and fungi.”

Your PolyMeal Body Fuel, Cardioplex, Super Curcumin Complex with Boswellia, CoQ-10 & Cinnamon, and Colloidal Silver 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 based on 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 PolyMeal Body Fuel, Cardioplex, Super Curcumin Complex with Boswellia, and CoQ-10 & Cinnamon products are intended for prevention or 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 these products safely for their intended purposes. Accordingly, your PolyMeal Body Fuel, Cardioplex, Super Curcumin Complex with Boswellia, and CoQ-10 & Cinnamon 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)].

In addition, your Colloidal Silver product is labeled as containing colloidal silver as an active ingredient. According to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. § 352].

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)].

The violations cited in this letter are not intended to be an all-inclusive statement 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 your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each steps being taken to prevent the recurrence of violations, as well as copies of related documentation. 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 cannot complete corrective action within fifteen working days, state the reason for you’re the delay and the time within which you will complete the correction.

Please send your written response to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number CMS# 595025 when replying. If you have any questions regarding this letter, please contact Robert McNab, Compliance Officer, at robert.mcnab@fda.hhs.gov or (949) 608-4409.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5


Cc:
Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435