# FDA WARNING_LETTER - PREMIER NUTRA PHARMA Inc. - March 19, 2019

Source: https://www.keypedia.com/records/warning_letter/premier-nutra-pharma-inc/40e0ef1a-1d55-4fc0-a35f-ef47bedda39f

> FDA WARNING_LETTER for PREMIER NUTRA PHARMA Inc. on March 19, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: PREMIER NUTRA PHARMA Inc.
- Inspection Date: 2019-03-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Nutra Pharma Corp. on March 11, 2019, following a review of their websites (www.Nyloxin.com, www.nutrapharma.com) and social media (Facebook, Twitter). The FDA determined that Nutra Pharma Corp.'s "Nyloxin Oral Spray," "Nyloxin Topical Gel," "Nyloxin Topical Roll-On," "Nyloxin Topical Roll-On ES," "Nyloxin Professional Size Pump Topical Gel," and "Regular Strength Sample Pack" products are unapproved new drugs and misbranded drugs.

The products are considered drugs under section 201(g)(1) of the FD&C Act due to claims on their websites and social media indicating intended use for diagnosing, curing, mitigating, treating, or preventing diseases, or affecting body structure/function. These claims include treating rheumatoid arthritis, various cancers, chronic pain, herpes zoster, diabetes, fibromyalgia, and opioid addiction.

The products are unapproved new drugs because they are not generally recognized as safe and effective for their intended uses, violating sections 301(d) and 505(a) of the FD&C Act. They are also misbranded under section 503(b)(4) as prescription drugs lacking the "Rx only" symbol, and under section 502(f)(1) for failing to bear adequate directions for use

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