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WARNING LETTER

Nature’s Innovation, Inc. MARCS-CMS 648560 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
William S. Carlson
Recipient Title
CEO
Nature’s Innovation, Inc.

5317 Palmero Court
Buford, GA 30518
United States

info@naturesinnovation.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

August 18, 2023

RE: 648560

Dear William Carlson:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.naturasil.com in July 2023. We also reviewed your social media websites at www.instagram.com/naturasil/ and www.facebook.com/Naturasil/, where you direct consumers to your website, www.naturasil.com, to purchase your products. The FDA has observed that your website offers your “Naturasil Molluscum Treatment Kit”1 and “Naturasil Shingles” products for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.

Molluscum contagiosum is not a condition amenable to self-diagnosis and treatment, and there are no legally marketed over-the-counter (OTC) drug products to treat this condition. Molluscum contagiosum is a viral skin infection characterized by small, raised lesions on the skin that are known as Mollusca. Molluscum affects both children and adults; however, it is more common in children. In healthy individuals, the lesions usually disappear spontaneously within 6 to 12 months, although in some cases, it could take years to resolve. In sexually active individuals, the lesions found in the genital region are considered a sexually transmitted disease/infection (STD/STI). In addition, patients with new or existing skin lesions should seek out a healthcare professional to be evaluated. A healthcare professional is needed to rule out the possibility of a more serious condition, such as, skin cancer, fungal infection, and for the genitalia, anogenital warts. Your “Naturasil Molluscum Treatment Kit” is especially concerning from a public health perspective because it is marketed for use in children. In addition, FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.

Your “Naturasil Shingles” product is concerning for various reasons. Shingles is a serious condition that is not amenable to either diagnosis or treatment by a lay person, and there are no legally marketed OTC drug products to treat this condition. Treatment of shingles requires antiviral therapy, and early treatment is key to promote healing of the rash and reduce the severity and duration of pain. A person with shingles can potentially spread the varicella-zoster virus to others. Furthermore, FDA is concerned that people who use an unapproved drug product claiming to treat shingles are putting themselves at risk for developing serious complications, e.g., postherpetic neuralgia (long-term nerve pain), herpes zoster ophthalmicus (which can lead to vision loss), and skin infections.

Unapproved New Drugs

Based on a review of your websites, your “Naturasil Molluscum Treatment Kit” and “Natural Shingles” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples of claims from your websites that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

Naturasil Molluscum Treatment Kit

On the product webpage for “Naturasil Molluscum Treatment Kit,” https://www.naturasil.com/pages/molluscum-contagiosum-treatment-kit?_pos=12&_sid=acf8ae577&_ss=r:
• “NATURASIL FOR MOLLUSCUM IS THE NUMBER 1 All Natural, No Acids, Pain-Free Remedy for Children and Adults, Made in the USA. Parent Approved!”
• “Naturasil for Molluscum Treatment Kit . . . Get rid of Molluscum at home with this PAIN-FREE BREAKTHROUGH 100% Natural Molluscum Contagiosum Treatment. CHILD-SAFE (2 years old & above) Causes Molluscum to dry up and flake away painlessly over time.”
• “Effectively & gently clears Molluscum bumps Relieves itching & discomfort”
• “Naturasil for Molluscum Treatment Kit for Children and Adults… Best for treating Genitals and other sensitive areas and children or adults with large or severe Molluscum outbreaks.”

From a September 6, 2022 blog post entitled, “MOLLUSCUM CONTAGIOSUM | SIGNS AND SYMPTOMS OF AN INFECTION,” https://www.naturasil.com/blogs/naturasil-blogs/molluscum-contagiosum-signs-symptoms?_pos=8&_sid=c37dd889d&_ss=r:
• “Regardless, effective natural remedies, such as the Naturasil Molluscum Contagiosum Treatments are designed to penetrate viral cells to quicken your recovery time.”

From a June 10, 2022 blog post entitled, “Natural Treatment Options for Molluscum Contagiosum,” https://www.naturasil.com/blogs/naturasil-blogs/natural-treatment-options-for-molluscum-contagiosum?_pos=7&_sid=c37dd889d&_ss=r:
• “Naturasil's Molluscum Contagiosum Treatment was constructed with the most potent ingredients throughout the herbal industry. Each compound injects a vast array of nutrients capable of hindering the health and development of the molluscum virus.”
• “Naturasil for Molluscum is a completely natural treatment solution that eradicates this awful condition often found in children quickly and safely without the use of harsh chemicals.”

On your Facebook social media page https://www.facebook.com/Naturasil/:
• March 15, 2023 post: “Most Trusted Molluscum Brand Effectively & #gently #clears #Molluscum #bumps #Relieves #itching & #discomfort”
• October 8, 2022 post – Your post includes some of the following hashtags: “#molluscumcontagiosum,” “#kidsafe,” “#natural,” “#remedy,” “#treatment” with an image of your “Naturasil Molluscum Treatment Kit” product and text that reads “I wish I could share before and after photos, his molluscum is almost gone with a few more treatments it will be . . . My 3 year [old] has had it for 1.5 years and nothing worked. Thank you soo [sic] much Naturasil.”

On your Instagram social media page https://www.instagram.com/naturasil/?hl=en:
• August 4, 2022 post – Your post includes an image of your “Naturasil Molluscum Treatment Kit” product and text that reads “It works! We’ve been using the product for a few weeks and I can definitely see an improvement in my daughter’s sports. Some are shrinking and others are drying up. We have had the best results when applying it 4-5 times a day. It requires patience, but is the only thing I’ve seen that works!”

Naturasil Shingles

On the product webpage for “Naturasil Shingles,” https://www.naturasil.com/pages/shingles-15ml:
• “Naturasil for Shingles assists the body in reducing and eliminating shingles outbreaks naturally and effectively, without the harmful side effects found in many shingles treatment drugs, through a topical application that is absorbed into the skin at the site of the outbreak.”
• “The active components of our shingles treatments are high levels of neral, geraniol, alpha-terpinenes, and linalool. All anti-viral and anti-inflammatory compounds are found in Melissa Officinalis, melaleuca alternifolia, agathophyllum aromatica, and other critical anti-viral plant extracts. These compounds have anti-viral properties and effectively combat the herpes zoster virus that causes shingles.”
• “END THE SHINGLE NIGHTMARE NOW. Get the all-natural, #1 REMEDY, complete package for treating YOUR Shingles.”

Your “Naturasil Molluscum Treatment Kit” and “Natural Shingles” products are not generally recognized as safe and effective (GRASE) for their above 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 introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products.2 Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

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 fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C 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 the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.

Sincerely,
/S/

Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

__________________________

1 On your website, www.naturasil.com, you state that your “Naturasil Molluscum Treatment Kit” product consists of your “Naturasil Molluscum Topical Liquid” and your “Naturasil Molluscum Relief Soap” products.

2 We recognize that the “Naturasil Molluscum Treatment Kit” and “Naturasil Shingles” labeling describes the products as being “homeopathic.”

First, we note that under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” Your above-mentioned drugs include non-homeopathic ingredients that, although listed as “inactive ingredients,” are considered active ingredients under 21 C.F.R. 201.66(b)(2) because they are promoted on your website in various places with claims to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or any function of the body. These other active ingredients are not listed in dilutions and at least some are not listed in the HPUS, and thus these products fall outside the scope of products addressed in this guidance. Notwithstanding, even if your above listed products were considered “homeopathic drug products" under this guidance, these products would fall under the guidance’s categories of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.

 
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