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  5. Day Light Nutrition - 653234 - 08/04/2023
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WARNING LETTER

Day Light Nutrition MARCS-CMS 653234 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Alvin Morrow
Recipient Title
Owner
Day Light Nutrition

8565 Airport Rd.
St Louis, MO 63134
United States

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

United States

WARNING LETTER

August 4, 2023

Re: CMS Case# 653234

Dear Mr. Morrow:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.daylightnutrition.com in July 2023 and has determined that you take orders there for the products Above the Weather, Diabetic Support Blend, Joint Well, and ViruZap. The claims on your website establish that these 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 claims that provide evidence that your products Above the Weather, Diabetic Support Blend, Joint Well, and ViruZap are intended for use as drugs include:

On the image of the product label for the Above the Weather product from your website:

• “Flu Symptoms”
• “Runny Nose”
• “Congestion”

On the product page for Above the Weather, under the Description tab:

• “Above The Weather cold season wellness formula works to assist the body’s immune system.
Fighting off unwanted cold symptoms & winter related illness. Excellent support for the occasional runny nose, nasal congestion, flu, or sinus infection.”

On the product page for Diabetic Support Blend, under the Description tab:

• “Diabetic support supplement helps to assist insuline [sic] resistant individuals and blance [sic] unhealthy blood sugar glucose levels. Great product [sic] people who are diabetics or condidered [sic] borderline.”
• “Our Glucose Support formula offers several patented and trademarked ingredients backed by scientific research demonstrating their positive effects on glucose control.”

On the image of the product label for the Joint Well product from your website:

• “PAIN & INFLAMMATION”

On the product page for Joint Well, under the Description tab:

• “JOINT WELL: SUPPORTS JOINT PAIN & INFLAMMATION”
• “Arthritis Relief For Joint Pain & Arthritis Symptoms”
• “Joint Well supports arthritis pain relief from inflammation and stiff joints.”
• “…reduce pain and discomfort associated with inflammation”

On the image of the product label for the ViruZap product from your website:

• “Natural Antiviral Support”
• “100% HERBAL ANTI VIRAL BLEND”

On the product page for ViruZap, under the Description tab:

• “Vitamin C (as micronized ascorbic acid) - is an antioxidant that can stimulate & up-regulate immune response. This increases the chances to win the fight against infection.”
• “Magnesium … Transmits signal to activate immune response to infection.”
• “Elderberry is quite effective in protecting and treating infections of the upper respiratory tract. Studies reveal that elderberry helps in reducing the excessive secretion of sinus mucus. Research has shown that Elderberry helps to reduce the swelling in mucous membranes, by adressing [sic] difficulties related to sinus drainage, and decreases nasal congestion in people suffering from bacterial sinusitis.”
• “Olive Leaf Extract - Boosts weakened immune system by neutralizing free radical cell damage. Naturally kills pathogens such as bacteria, parasites, viruses, and fungi, by preventing them from reproducing. Oleuropein, one of the primary compounds in olive leaf, has attracted attention since the early 1900s because of its antiviral, antibacterial and antifungal properties.”
• “Andrographis - Also known as ‘Indian Echinacea,’ …These compounds…have antiinflammatory, antiviral…properties. Andrographis is a natural immune system booster according to scientific clinical trials. It is widely used in relieving acute upper respiratory tract infections such as cold and flu symptoms.”
• “Kudzu - an herb used in ancient medicine to ease an upset Stomach Ache.”
• “Bonset - is often used to reduce fever associated with influenza, pneumonia and swine flu. And is also used as a stimulant; and to cause sweating.”
• “N-Acetyl-L-Cysteine - is commonly used to reduce the inflammation and mucus. It can break down mucus and replenish glutathione in the lungs, which reduces airway damage and breathing difficulties.”
• “Garlic Bulb Extract - contains antimicrobial, antiviral and antifungal properties that assist in alleviating colds as well as other infections.”
• “Turmeric Extract (95% Curcumin) … that acts as a natural anti-inflammatory.”
• “Quercetin Dhydrate [sic] - is a natural antihistamine that can help stop damaging particles in the body known as free radicals, which negatively impact how cells work. “… [A]nd acts as an antiinflammatory.”
• “Oregano Leaf Extract - contains anti-microbial properties that are used to alleviate the symptoms of upper respiratory tract infections. Oregano extract acts as an expectorant. Expectorants loosen and even eliminate mucus and phlegm in an individuals sinuses and respiratory system. Inflammation can also play a role in bronchitis and the coughing that often accompan [sic]”

Your Above the Weather, Diabetic Support Blend, Joint Well, and ViruZap 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)]. With certain exceptions not applicable here, 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 Above the Weather, Diabetic Support Blend, and ViruZap products are intended for treatment of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention 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 above 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 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 response should be sent to U.S. Food and Drug Administration, Attention: Andrew A. Hoopes, Compliance Officer, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have questions regarding this letter, please contact Compliance Officer Hoopes at (515) 244-0480 ext. 1002 or via email at: andrew.hoopes@fda.hhs.gov.

Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
Program Division Director,
Office of Human and Animal Food
Operations, West Division II 

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