Nutra Pharma Responds to FDA Warning Letter
Nutra Pharma has provided a response to the FDA warning letter sent to the company on March 11, 2019 regarding Nutra Pharma’s homeopathic drug, Nyloxin®.
April 10, 2019 -- Coral Springs, Florida -- Nutra Pharma Corporation (OTC: NPHC), a biotechnology company marketing Nyloxin® and Pet Pain-Away™ in the over-the-counter (OTC) pain management market, announced today that the Company has responded to an FDA warning letter that was issued on March 11th regarding the company’s website and social media sites for the sales and marketing of their Nyloxin® products.
“The Company takes the FDA warning letter very seriously,” commented Rik J Deitsch, Nutra Pharma’s Chief Executive Officer. “We have been working diligently with our internal staff, outside consultants and our legal team to address the entirety of the FDA’s concerns with our marketing materials for Nyloxin,” he continued. “It is our intention to work with the FDA and government regulators to make sure that our exceptional products can continue to be marketed to the people that need them most,” he concluded.
In partial response to the FDA’s letter, Nutra Pharma stated, “We agree that under the FD&C Act the definition of “drug” includes articles recognized in the Official United States Pharmacopeia (“USP”) and the Homeopathic Pharmacopeia of the United States (“HPUS”) or any of their supplements. We believe that the Nyloxin Products meet the requirements of the HPUS, and therefore, constitute homeopathic drugs. That said, we understand that the FDA has concerns with the labeling, branding and claims asserted in connection with the Nyloxin Products. As noted, Nutra Pharma has promptly endeavored to either (a) explain the basis of each of its claims as they relate to the concerns identified in the Warning Letter, (b) remove the claim from all of the marketing materials for the Nyloxin Products, and/or (c) agreed to correct any potentially confusing/misleading statements within thirty days of this letter.” Additionally, the response stated, “We firmly believe that the formulae contained in the Nyloxin Products meets the standards set forth in the HPUS Monograph and that they are safe and effective for the conditions recommended or suggested in their labeling.”
The response goes on to commit to the FDA that the company will make the changes necessary to properly and legally continue to market and distribute its products.
“Fully knowing the benefits of these products, we will continue to work with the FDA and others to assure the continued availability of Nyloxin for those who need it most,” commented Dale Vander Putten, PhD; Nutra Pharma’s Chief Scientific Officer.
Nyloxin® is a safe, non-narcotic, and non-addictive Homeopathic pain reliever for the relief of pain without impairing cognitive function. Nyloxin® offers several benefits as pain relievers and anti-inflammatory agents. Nyloxin® has a well-defined safety profile. Since the early 1930s, the active pharmaceutical ingredient (API), Asian cobra venom, has been studied in more than 46 human clinical studies.
About Nutra Pharma Corp.
Nutra Pharma Corporation operates as a biotechnology company specializing in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases, including Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain. Additionally, the Company markets drug products for sale for the treatment of pain under the brand Nyloxin® and Pet Pain-Away™. For additional information about Nutra Pharma, visit:
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company’s response to the FDA warning letter should not be construed as an indication in any way whatsoever of the future value of the Company’s common stock or its financial value. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.