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.”
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