FDA issued a warning letter to Valentus, Inc. alleging the company made drug claims for their products on its website, as the products in question are intended for use in the cure, mitigation, treatment, or prevention of disease. After reviewing the companies websites, FDA highlighted several claims that allegedly establish the products as drugs, including:
- “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.”
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“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….”
FDA further advised that a drug is misbranded when it fails to bear "Adequate directions for use," which are directions under which a layperson can use a drug safely and for the purposes for which it is intended; and that under FD&C Act [21 U.S.C. § 353(b)(1)(A)] "Prescription drugs, can only be used safely at the direction, and under the supervision, of a licensed practitioner." The agency notes that as the products cited within the warning letter are intended for the prevention or treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner, it is therefore impossible to write adequate directions for a layperson to use these products safely for their intended purposes.
Finally, the agency advised that the company should take prompt action to correct the alleged violations cited in the letter, and that failure to correct the alleged violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
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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:
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:
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“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.
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