Nature’s Innovation, Inc.
FDA issued a warning letter to Nature's Innovation, Inc. (CEO William Carlson) on August 18, 2023, after reviewing the company's website and social media pages and finding that its 'Naturasil Molluscum Treatment Kit' and 'Naturasil Shingles' products were being marketed as treatments for molluscum contagiosum and shingles without FDA approval. The products were deemed unapproved new drugs under section 505(a) of the FD&C Act because the marketing claims established drug intent, and neither product is generally recognized as safe and effective for the claimed uses. FDA expressed particular public health concern because the molluscum product is marketed for children and the shingles product could cause patients to forgo necessary antiviral treatment. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.
Flagged claims (10)
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.
Best for treating Genitals and other sensitive areas and children or adults with large or severe Molluscum outbreaks.
Effectively & gently clears Molluscum bumps Relieves itching & discomfort
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.
END THE SHINGLE NIGHTMARE NOW. Get the all-natural, #1 REMEDY, complete package for treating YOUR Shingles.
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.
effective natural remedies, such as the Naturasil Molluscum Contagiosum Treatments are designed to penetrate viral cells to quicken your recovery time.
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.
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 THE NUMBER 1 All Natural, No Acids, Pain-Free Remedy for Children and Adults, Made in the USA. Parent Approved!
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker