WARNING LETTER
Hevert Pharmaceuticals LLC USA
MARCS-CMS 594842 —
June 11, 2020
Product:
Drugs
Recipient:
Recipient Name
Elizabeth Spannuth
Hevert Pharmaceuticals LLC USA
4770 Baseline Rd, Suite 219
Boulder
,
CO
80303
United States
info@hevertusa.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
June 11, 2020
RE: 594842
Dear Ms. Spannuth:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your product labeling for your injectable products “Arnica,” “Calmvalera comp.,” “Gelsemium comp.,” “Hepar comp.,” and “Lymphaden comp.,” including your products’ labels and your website at hevert.com, from which these products can be ordered. Based on our review, these injectable products are unapproved new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355. Introducing or delivering these products for introduction into interstate commerce violates section 301 of the FD&C Act, 21 U.S.C. 331.
These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users; these risks are less likely to occur with topical or ingested products, i.e., those applied to the skin or taken by mouth. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions. Your injectable products are further concerning because they are labeled to contain potentially toxic ingredients, such as “nux vomica” (contains strychnine) and “plumbum aceticum” (lead), thereby presenting additional risk of serious harm to patients when delivered directly into the body.
Statements on your products’ labels, as well as your firm’s website, that establish the intended uses of your products include, but are not limited to, the following:
“Arnica”
• “[I]ndicated for the treatment of muscle pain and stiffness, bruising and swelling due to injuries and overexertion.”
“Calmvalera comp.”
• “[I]ndicated for the treatment of nervous disorders, such as restlessness and sleep disorders, mild depressive states, and mental exhaustion.”
“Gelsemium comp.”
• “[I]ndicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain.”
“Hepar comp.”
• “[I]ndicated for the improvement of liver and biliary system disorders.”
“Lymphaden comp.”
• “[F]or the improvement of conditions such as swelling of the lymph nodes, and lymphatic edema.”
The above claims for “Arnica,” “Calmvalera comp.,” “Gelsemium comp.,” “Hepar comp.,” and “Lymphaden comp.” demonstrate that they are drugs, as defined by section 201(g) of the FD&C Act, 21 U.S.C. 321(g), because they are intended to cure, mitigate, treat, or prevent disease and/or intended to affect the structure or function of the body of man or other animals. Moreover, these products are “new drugs,” as defined by 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).
We recognize that “Arnica,” “Calmvalera comp.,” “Gelsemium comp.,” “Hepar comp.,” and “Lymphaden comp.” are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” 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 drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or approval.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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 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. In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination. For more information about detention without physical examination, see Import Alert 66-41.
Within fifteen (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 cannot complete corrective action 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 by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
cc:
Christopher Nickel
cnickel@hevert.de
Hevert Arzneimittel GmBH & Co.
In der Weiherweise 1
Nussbaum 55569 Germany
Friedemann Seitz
Friedemann.Seitz@solupharm.com
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestraße 3
Melsungen, Hesse
34212 Germany
Content current as of:
06/16/2020
Regulated Product(s)
Drugs