---

---

---

June 8, 2022

RE: CMS#626254

WARNING LETTER

Dear Ms. Salvadori:

The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement and cosmetics manufacturing and distributing facility located at 215 Linda Vista Drive, Hendersonville, NC from October 28-29, 2021, during which we collected product labels and brochures. We also reviewed your website at the Internet address www.mynewsun.com in May 2022, and have determined that you take orders there for the products Advanced Liver Plus, Advanced U-Tract, Bilberry Eyebright, Calcium Magnesium Liquid, Elderberry Plus Vitamin C, Lymphatic Cleanser, NKC, Para-CL, Yew/Olive Combination, Kidz DHA, and Kidz Super Dophilus, as well as the products Ultra CBD Oil (Hemp Oil), CBD Gummies, and Advanced CBD Oil (Hemp Oil), which you represent as containing cannabidiol (CBD) (hereinafter referred to as “New Sun products”). The claims on your website and on other product labeling establish that your New Sun products are drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)] 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. You can find specific information about how FDA regulates cannabis-derived products at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

The Agency is particularly concerned that you market one of your unapproved new drug products as safe for children. Your product webpage for Advanced CBD Oil (Hemp Oil) states that “Hemp Seed Oil (CBD) is a dietary supplement, and is safe to be consumed on a daily basis by adults as well as children.” Your product has not been evaluated by the Agency for safety, effectiveness, and quality. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.

Dietary Supplement Labeling

Information on your website at www.mynewsun.com indicates you intend to market your Ultra CBD Oil (Hemp Oil), CBD Gummies, and Advanced CBD Oil (Hemp Oil) products as dietary supplements. Specifically, the product webpages display images of the product labels with a supplement facts panel. However, your CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the Act [21 U.S.C. 321(ff)]. FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the Act [21 U.S.C. 321(ff)(3)(B)(i) and (ii)]. Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the Act [21 U.S.C. 355] or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.¹ There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the Act, but you may present FDA with any evidence that has bearing on this issue.

Unapproved New Drugs

Based on our review of your website and product labeling (brochures), your New Sun products are drugs under section 201(g)(1) of the Act [21 U.S.C. 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

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

On your webpage for “Advanced Liver Plus”:

• “Milk thistle [an ingredient in Advanced Liver Plus] can aid in lowering cholesterol and blood sugar.”
• “Advanced Liver Plus, a supplement that contains milk thistle….Milk thistle is used as a natural aid for liver problems. These liver problems may include cirrhosis, jaundice, hepatitis and gallbladder disorders. Milk thistle benefits may also include lowering cholesterol levels and helping people who have type 2 diabetes. Studies have shown a decrease in blood sugar. It may also help protect against heart disease.”
• “The following are some of the benefits of Advanced Liver Plus: . . . May promote improve blood sugar and cholesterol levels”

On your webpage for “Advanced U-Tract”:

• “Helps prevent Urinary Tract Infections (UTIs)”
• “Our Advanced -U- Tract Capsules consists of one simple ingredient: D-mannose, which is used to help prevent bacteria from adhering to the walls of the urinary tract and, as a result, reduce the occurrence of urinary tract infections. With our Advanced -U- Tract, you can … help reduce your reliance on antibiotics.”
• “D-mannose helps stop the discomfort of urinary tract infections and bladder issues.…UTIs in men have been linked to inflamed prostate glands, which can cause chronic prostate problems.”
• “Our natural Advanced -U- Tract can help prevent urinary tract and bladder issues”
• “The following are some of the benefits of Advanced -U- Tract Capsules: . . .

  o Assists in reducing inflamed prostate glands in men, which can cause chronic problems.
  o Can prevent bacteria from adhering to the walls of the urinary tract.”

On your webpage for “Bilberry Eyebright+”:

• “The studies [of Bilberry] reveal that blood vessels are strengthened, circulation improves, blood glucose levels may be lowered, prevention of cell damage are all benefits that Bilberry may provide.”
• “Eyebright has been traditionally used to treat all manner of eye maladies including; inflammation, conjunctivitis, red-eye, sties, itchy eyes, stinging eyes, and weak vision.”
• “Studies reveal the flavonoids luteolin and quercetin found in Eyebright contain antihistamine properties that have been used traditionally to treat seasonal allergies.”

On your webpage for “Calcium Magnesium Liquid”:

• “Magnesium has several additional benefits. . . . It neutralizes stomach acids and may help in resisting depression. It may also help in prevention of kidney stones and calcium deposits.”

On your webpage for “Elderberry Plus Vitamin C”:

• “Aids with cold, flu and virus symptoms”
• “Aids with infections”

On your webpage for “Lymphatic Cleanser”

• “Benefits of Lymphatic Cleanser: . . . Decrease in congestive issues such as headaches, acne, sinus problems, and bronchitis”

On your webpage for “NKC”:

• “New Sun’s NKC supplement contains a unique blend of several of these mushrooms:

  o The Agaricus blazei murill, or ABM….was traditionally used by patients with cancer, diabetes, and arteriosclerosis. Some studies done on mice have shown that this incredible mushroom can stimulate the immune system and may even have an anticancer effect within the body.”

On your webpage for “Para-CL”:

• “The ingredients found in Para-CL are known for the following health benefits: Reduction of parasitic infestations: Historically, black walnut has been used to reduce or treat infestations of parasites in the human body.”

On your webpage for “Yew/Olive Combination”:

• “Users have long extolled the needles of this medicinal tree [Pacific Yew] as . . . aid in reducing inflammation.”
• “Olive leaf is a rich source of many different helpful plant substances including polyphenols…. Polyphenols are a potent antimicrobial and work against viruses, bacteria, and fungi. Olive leaf . . . can interfere with viral replication and infection, and may even help stimulate phagocytosis, where immune cells gobble up pathogens and foreign matter.”

On your webpage for “Ultra CBD Oil (Hemp Oil)”:

• “Benefits of Ultra CBD Oil: . . .

  o May help with lowering cholesterol as well as assist with moderating blood sugar levels
  o May help…prevent damage to the myelin sheath, and help as a blood thinner, thus aiding with reducing blood clots and varicose veins”

On your webpage for “CBD Gummies”:

• “CBD Gummies may help relieve pain, inflammation, anxiety, and depression.”
• “May relieve pain and inflammation, and aid with anxiety and depression.”
• “May help reduce symptoms related to cancer and side effects related to cancer treatment, like nausea, vomiting and pain.”
• “May reduce acne due to its anti-inflammatory properties and ability to reduce the production of sebum, which is oil produced by the sebaceous glands in the skin.”
• “May assist with neurological disorders.”
• “Studies indicate that CBD may be able to help with high blood pressure.”

On your webpage for “Advanced CBD Oil (Hemp Oil)”:

• “The elements in CBD may … help with lowering cholesterol as well as assist with moderating blood sugar levels, … prevent damage to myelin sheath, and help as a blood thinner, thus aiding with reducing blood clots and varicose veins.”

On your webpage “Supplements for Respiratory Health”:

• “Our respiratory supplements may also promote:

Reduction of mucus and fluid in the lungs
Reduction of bacteria, toxins and irritants in the lungs
Reduction of chest tightness, wheezing and shortness of breath
Reduction of coughing and sore throat
Minimization of the effects of asthma
Pain reduction, including relief from headaches
Reduction in joint pain, inflammation and swelling”

• “Many of our products also have antiseptic, anti-microbial, anti-inflammatory, anti-fungal and immune-stimulating properties.”
• “Ingredients Common to [New Sun] Respiratory Support Supplements…”

  o “Mullein leaves [an ingredient in your Lymphatic Cleanser product]….can help relieve symptoms of colds or the flu, and can also act as a treatment for allergies, asthma and bronchitis. Mullein has anti-bacterial and anti-inflammatory properties.”
  o “Vitamin C [an ingredient in your Elderberry Plus Vitamin C product] helps ease colds…and may help protect against cardiovascular disease, [and] eye disease”

On your webpage “Supplements for Circulatory Health”:

• “Our supplements target a range of circulatory issues such as fatigue, cholesterol, and blood clotting”
• “Ingredients common to Circulatory Support Supplements….Slippery elm [an ingredient in your Para-CL product] is extracted from the inner bark of the tree. It is used medicinally to protect the stomach from ulcers and irritations, and to relieve burns and sores on the skin.”

On your webpage “Supplements for Urinary Health”:

• “Our Urinary supplements can also promote:

  o Prevention of Urinary Tract Infection (UTIs)
  o …[r]eduction of kidney stones
  o Reduced risk of prostate problems, including the reduction of inflamed prostate glands

• “Some of our products may have…anti-bacterial, anti-fungal, anti-inflammatory, and antiseptic properties”

On your product labeling (brochure) for “Kidz DHA”, which directs consumers to your website www.mynewsun.com, where the product is available for purchase:

• “DHA supplements are purported to treat certain health problems in children, such as allergies, asthma, and attention deficit-hyperactivity disorder (ADHD).”

On your product labeling (brochure) for “Kidz Super Dophilus”, which directs consumers to your website www.mynewsun.com, where the product is available for purchase:

• “Probiotics [an ingredient in your Kidz Super Dophilus product] may help relieve acute constipation, colic, and acid reflux in healthy infants and children. They may also prevent secondary infections and diarrhea in kids using antibiotics. Probiotics may even help prevent eczema and allergies in some children.”

Your above New Sun products are not generally recognized as safe and effective for the referenced uses and, therefore, these 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) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products.

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 Advanced Liver Plus, Advanced U-Tract, Calcium Magnesium Liquid, Lymphatic Cleanser, Ultra CBD Oil (Hemp Oil), CBD Gummies, Advanced CBD Oil (Hemp Oil), NKC, and Kidz DHA products are intended for the 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, Advanced Liver Plus, Advanced U-Tract, Calcium Magnesium Liquid, Lymphatic Cleanser, Ultra CBD Oil (Hemp Oil), CBD Gummies, Advanced CBD Oil (Hemp Oil), NKC, and Kidz DHA 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.

In addition, we offer the following comment: We note that your website includes the statement that “New Sun Hemp Classic CBD Oil and Advanced Hemp CBD Oil are made . . . in an FDA approved facility.” Although certain facilities must register with FDA, FDA does not approve facilities.

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.

Please send your reply to the Food and Drug Administration, Attention: Victoria Palmer, Compliance Officer, 60 8th Street, N.E. Atlanta, GA 30309 or via email at Victoria.palmer@fda.hhs.gov (preferred). If you have questions regarding the content of this letter you may contact Victoria L. Palmer, Compliance Officer, either via telephone at 404-253-1173, or via email at victoria.palmer@fda.hhs.gov.

Sincerely,
/S/

Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Foods Operations-East 3

_____________________

1 CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act.