03.20.19
The US FDA has issued a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions. The products included topical treatments as well as an oral spray.
Specifically, FDA issued a warning letter to Nutra Pharma for: "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."
These products also may confuse consumers because its name is similar to FDA-approved drugs, said FDA.
Examples of claims made include:
FDA said it deteremined the company’s 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), and misbranded drugs under sections 503(b) and 502 of the FD&C Act, 21 U.S.C. 353(b) and 352. FDA said introducing or delivering these products for introduction into interstate commerce violates section 301 of the FD&C Act, 21 U.S.C. 331.
Your firm’s products, “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,” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended to diagnose, cure, mitigate, treat, or prevent disease, and/or intended to affect the structure or any function of the body.
In its letter, FDA said examples of claims on the company’s websites and social media website that establish the intended use for your products above include, but are not limited to, the following:
FDA also pointed out issues with statements on the company’s Facebook and Twitter Social Media websites
FDA said the products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. “Adequate directions for use” is defined in 21 CFR 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended, said FDA. ” Because the conditions for which your above products are intended (i.e., rheumatoid arthritis, various cancers, chronic pain, cancer pain, herpes zoster, diabetes, fibromyalgia, and opioid addiction) require the supervision of a practitioner licensed by law to administer such drugs, adequate directions cannot be written so that a layperson can use your products safely. Thus, your products’ labeling fails to bear adequate directions for use, which causes these products to also be misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
The agency also had issues with the use of its logo and terminology.
FDA said that a repeated footer on your website (https://nyloxin.com) displays the phrase “FDA Registered” next to your logo for “Nyloxin -- Chronic Pain Relief”. In that presentation, the term “FDA” appears in a unique graphical form used as the agency’s official logo for many years. Among other places, this footer appears on the “Shopping Cart” page on which products selected for order appear. This presentation is false or misleading. The assertion of “FDA Registered” status in conjunction with the Nyloxin logo in the website’s footers misleadingly suggests that the Nyloxin drug products are themselves approved or endorsed by FDA in some way when this is not true, an impression reinforced by the use of an FDA logo.
Specifically, FDA issued a warning letter to Nutra Pharma for: "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."
These products also may confuse consumers because its name is similar to FDA-approved drugs, said FDA.
Examples of claims made include:
- "Nyloxin . . . treats conditions that cause chronic pain."
- "[C]obra venom saw its primary use in the treatment of cancer and arthritis. Reportedly the venom was used to treat liver cancer, lung cancer, esophageal cancer, skin cancer, and leukemia."
- "Today, cobra venom is being studied for treating various forms of pain, cancers, autoimmune and neurological disorders."
- "Researchers in China are examining the possibility that cobra venom can be used to treat drug addiction."
- "Treatment of the Cobrotoxin in 90 cases with heroin dependence."
FDA said it deteremined the company’s 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), and misbranded drugs under sections 503(b) and 502 of the FD&C Act, 21 U.S.C. 353(b) and 352. FDA said introducing or delivering these products for introduction into interstate commerce violates section 301 of the FD&C Act, 21 U.S.C. 331.
Your firm’s products, “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,” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended to diagnose, cure, mitigate, treat, or prevent disease, and/or intended to affect the structure or any function of the body.
In its letter, FDA said examples of claims on the company’s websites and social media website that establish the intended use for your products above include, but are not limited to, the following:
FDA also pointed out issues with statements on the company’s Facebook and Twitter Social Media websites
FDA said the products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. “Adequate directions for use” is defined in 21 CFR 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended, said FDA. ” Because the conditions for which your above products are intended (i.e., rheumatoid arthritis, various cancers, chronic pain, cancer pain, herpes zoster, diabetes, fibromyalgia, and opioid addiction) require the supervision of a practitioner licensed by law to administer such drugs, adequate directions cannot be written so that a layperson can use your products safely. Thus, your products’ labeling fails to bear adequate directions for use, which causes these products to also be misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
The agency also had issues with the use of its logo and terminology.
FDA said that a repeated footer on your website (https://nyloxin.com) displays the phrase “FDA Registered” next to your logo for “Nyloxin -- Chronic Pain Relief”. In that presentation, the term “FDA” appears in a unique graphical form used as the agency’s official logo for many years. Among other places, this footer appears on the “Shopping Cart” page on which products selected for order appear. This presentation is false or misleading. The assertion of “FDA Registered” status in conjunction with the Nyloxin logo in the website’s footers misleadingly suggests that the Nyloxin drug products are themselves approved or endorsed by FDA in some way when this is not true, an impression reinforced by the use of an FDA logo.
