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WARNING LETTER

 

 

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

 

March 11, 2019

 

Rik J. Deitsch, Chairman and CEO

Nutra Pharma Corp.

12538 W. Atlantic Blvd.

Coral Springs, FL 33071

 

RE: 563949

Dear Mr. Deitsch:                                                                              

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.Nyloxin.com, from which you take orders for your 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”[1]. We also reviewed your website www.nutrapharma.com and social media websites at www.facebook.com/NyloxinRelief/ and https://twitter.com/nyloxin; these websites direct consumers to your website www.Nyloxin.com to purchase your products. Based on our review, FDA has determined that your 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. Introducing or delivering these products for introduction into interstate commerce violates section 301 of the FD&C Act, 21 U.S.C. 331. You may find the FD&C Act and FDA regulations through links on FDA’s website at www.fda.gov.  

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. Examples of claims on your websites and social media websites that establish the intended use for your products above include, but are not limited to, the following:

On your www.Nyloxin.com Website’s Homepage:

• “Rheumatoid Arthritis and Chronic Joint Pain!” 

On your www.Nyloxin.com Website Titled “How Nyloxin Works”:

• “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.” 

On your www.Nyloxin.com Website Titled “Research & Studies”:

• “Nyloxin is supported by significant clinical evidence . . . documenting the effectiveness of cobra venom for the treatment of various types of pain, including cancer pain, chronic pain, neuralgia, and pain associated with parkinsons [sic], arthritis, and herpes zoster.”
• “The clinical treatment of diabetic kidney capsule of Cobra venom.”
• “Treatment of the Cobrotoxin in 90 cases with heroin dependence.”
• “Anti-asthmatic effects of immunization with cobra venom.”
• “The treatment of chronic arthritis with a combination of cobra venom . . ..”
• “Symptomatic treatment of Parkinsonism symptoms with cobra venom . . ..”
• “’Cobratoxin’ for clinical purposes, especially for the treatment of cancer pains . . ..”

On your www.Nyloxin.com Website Titled “FAQs”:

• “Nyloxin is a new product primarily aimed at treating moderate to severe chronic pain.”
• “Nyloxin may also provide relief from other forms of pain such as pain associated with cancer.”
• “Chronic pain may be related to a number of different medical conditions including diabetes, arthritis . . . fibromyalgia, cancer, shingles . . . previous trauma or injury.” 

On your www.nutrapharma.com Website’s Homepage:

• “Nutra Pharma Corp. offers homeopathic products for sale for the treatment of pain: Nyloxin®, the first over-the-counter (OTC) pain reliever clinically proven to treat moderate to severe (Stage 2) chronic pain, Nyloxin Extra Strength®, the only non-narcotic and non-addictive treatment for severe (Stage 3) pain . . ..”

On your Facebook and Twitter Social Media Websites:

• “Nyloxin Chronic Pain Relief”
• July 20, 2018 Post – “Jeff Gottfurcht became the first climber with rheumatoid arthritis to summit Mount Everest – and he used Nyloxin for pain relief!”
• April 27, 2018 Post – “I have chronic arthritis in my feet, knees, and hands. After four days of taking Nyloxin ES spray, I no longer have pain. My feet would swell up so bad in the morning I could barely walk, this no longer happens.”
• April 20, 2018 Post – “Studies show that cobra venom can be used to relieve chronic pain, neuralgia, and even cancer pain!”

Your “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 also new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA. No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1), identifies criteria for determining the prescription status of a product. Your above products are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), because in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. Therefore, these products are misbranded under section 503(b)(4) of the FD&C Act, 21 U.S.C. 353(b)(4), in that their label fails to bear the symbol, “Rx only.”

Your 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 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.” 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). 

In addition, 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. First, it is drug establishments that are subject to registration with FDA,[2] and FDA has no record of a drug establishment registration associated with NutraPharma Corporation, the only entity identified on the website. (The website footer states “Nyloxin is a registered Trademark of NutraPharma Corporation.”)[3] Second, the placement of “FDA Registered” with your products’ logo suggests that the phrase refers to the Nyloxin drug products. To state that any drug product is “FDA Registered” is inaccurate; drugs are subject to listing with FDA, not registration.[4] Moreover, registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drugs of the establishment, nor does it mean that a product may be legally marketed. (21 CFR 207.77(a)). However, the general public is not likely to be familiar with the details of FDA regulation. 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. Thus, the products you offer for sale via https://nyloxin.com -- “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 misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading in any particular.

Section 301(a) of the FD&C Act, 21 U.S.C. 331(a), prohibits the introduction or delivery for introduction into interstate commerce of a misbranded drug.  

On October 26, 2017, the Acting Secretary of the Department of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. 274d, determined that a public health emergency exists nationwide involving the opioid crisis. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction.

We recognize that your 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 labeled as homeopathic drug products with an active ingredient measured in homeopathic strength. The definition of “drug” in section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same regulatory requirements as other drug products; nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many drug products labeled as homeopathic are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400)” (the CPG). However, the enforcement policies set forth in the CPG are not unlimited. The CPG states that it “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” The qualifying word “ordinarily” indicates that the CPG specifically contemplates that there may be circumstances where a product that otherwise may meet the conditions set forth in the CPG may nevertheless be subject to enforcement action.

As stated above, the Acting Secretary of Health and Human Services has determined that a public health emergency exists nationwide regarding opioid addiction and the consequences of the opioid crisis. A drug product labeled as homeopathic and marketed without FDA approval is not subject to the enforcement discretion set forth in the CPG when there is a nationwide public health emergency involving the disease that the product is intended to be used to diagnose, mitigate, prevent, treat or cure. Under these circumstances, the enforcement policies set forth in the CPG do not apply to your above products, regardless of their homeopathic status.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email to [email protected] 

 

Sincerely,

/S/

Donald D. Ashley

Director

Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

  

cc:

Rik Deitsch

(b)(6) 

 

[1] Sample pack includes a combination of the Oral Spray, Topical Gel, and Topical Roll-On in Regular Strength.

[2] Under section 510 of the FD&C Act, and 21 CFR Part 207, with some limited exceptions, firms that manufacture, prepare, propagate, compound, or process drugs in the United States or that are offered for import into the U.S. must register their establishments with the FDA, see FD&C Act sections 510(b), (c), (d), and (i) (21 U.S.C. 360(b), (c), (d), and (i)).

[3] We also note that the most recent drug listing information submitted to FDA for Nyloxin products identifies them as being manufactured in an establishment operated by Liquid Packaging Resources. That establishment registration expired on December 31, 2011, and has not been renewed.

[4] See FD&C Act section 510(j), 21 U.S.C. 360(j)) (establishing that every person who is required to register an establishment must, at the time of initial registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution, and must update this drug listing information at specified times thereafter); see also 21 CFR part 207, Subpart D.