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November 30, 2020

WARNING LETTER

Refer to CMS 609611

Dear Mr. Jordan:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at http://www.valentus.com in November 2020 and has determined that you take orders there for the products Valentus Prevail Breakthrough AM/PM, Valentus Prevail eMulin M, Valentus Prevail eMulin C, and Valentus PrevailMAX. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B), because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’ home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

On your product webpage for Valentus Prevail eMulin M:

• “Most diseases today are categorized as inflammatory diseases. Digestive issues, lack of energy, heart disease, asthma, skin disorders, alzheimers [sic], unmanageable weight gain, arthritis. Everyone suffers from chronic inflammation to some degree.”

Your product webpage also provides a link to a pdf that states:

• “Heavily sugar-laden diets can lead to diabetes, lupus, heart disease, obesity, strokes and more, which can have toxic (and sometimes fatal) effects. Why?

Because carbohydrates like sugar can increase inflammation to the body, and that inflammation can become the root cause of some detrimental disease. Emulin was formulated to significantly reduce the negative effects of carbohydrates (read: sugar)….”

On the image of your product label:

• “Inflammation manager”

On your product webpage for Valentus Prevail eMulin (relating to eMulin C and M):

• “Most diseases today are categorized as inflammatory diseases. Digestive issues, lack of energy, heart disease, asthma, skin disorders, alzheimers [sic]… arthritis….”
• “So that is why we recommend [Valentus Prevail eMulin] C for people with health problems like Diabetes, Hypertension, Cholesterol and [Valentus Prevail eMulin] M for those who just have problems with Energy and want to work on Obesity but both of them work very strongly in Anti-Inflammatory and bringing down Inflammation.”

Your product webpage also provides a link to a pdf regarding Valentus Prevail eMulin C that states:

• “Heavily sugar-laden diets can lead to diabetes, lupus, heart disease, obesity, strokes and more, which can have toxic (and sometimes fatal) effects. Why?”
• “Because carbohydrates like sugar can increase inflammation to the body, and that inflammation can become the root cause of some detrimental disease.”
• “Inflammation manager”

On your product webpage for Valentus Prevail Breakthrough AM/PM:

The ProDURA® (an ingredient in your Prevail Breakthrough AM/PM product) Overview Fact Sheet page found on your website states:

• “ProDURA has many of the same health benefits of most non-spore probiotics such as Lactobacillus acidophilus: the ability to inhibit E. coli and other pathogenic bacteria that are vancomycin-resistant…lower total cholesterol…. In addition, ProDURA has been used to treat bacterial vaginosis and diarrhea….”

On your product webpage for Valentus PrevailMAX:

Your product webpage provides a link to a pdf that states:

• “All of these factors damage red blood cells and create a condition commonly referred to as ‘sticky blood.’”

Your Valentus Prevail Breakthrough AM/PM, Valentus Prevail eMulin M, Valentus Prevail eMulin C, and Valentus PrevailMAX products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Valentus Prevail Breakthrough AM/PM, Valentus Prevail eMulin M, and Valentus Prevail eMulin C products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Valentus Prevail Breakthrough AM/PM, Valentus Prevail eMulin M, and Valentus Prevail eMulin C fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act, 21 U.S.C. § 331(a).

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 ensure that your firm complies with all requirements of federal law, including 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 imitation, seizure and injunction.

Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.

If you have questions regarding the content of this letter you may contact Carolyn A. Warren, Compliance Officer, by telephone (612) 758-7182 or email Carolyn.warren@fda.hhs.gov.

Sincerely,
/S/

Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations