H.E.A.L. Marketplace MARCS-CMS 646193 —
- Delivery Method:
- Overnight Delivery
Food & Beverages
Recipient NameMichael W. Dietz and Dara D. Dietz
- H.E.A.L. Marketplace
360 Carpenter Road
Rutherfordton, NC 28139-8552
- Issuing Office:
- Division of Human and Animal Food Operations East III
May 12, 2023
Re: CMS 646193
Dear Mr. and Mrs. Dietz:
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.healmarketplace.com and www.ladyofherbs.com (which re-direct or link to www.healmarketplace.shop) in March 2023, and has determined that you take orders there for the products Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula. The claims on your websites establish that the 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 the FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
• “To be used in cases of epilepsy, convulsions, lockjaw, delirium, tremors, fainting, cramps, hysteria, suspended animation, etc.”
• “This Antispasmodic Tincture has also been an effective aid for Kidney Stones.”
• “Echinacea Tonic stops colds dead in their tracks…”
• “Echinacea’s cold and flu fighting and healing ability alone has made it the #1 immune herb…”
• “[Echinacea Tonic] should be used for EVERY disease and illness.”
• “[I]nhibiting tumor growth, killing strep and staph bacteria, halting urinary tract infections, healing infected wounds, relieving hives and allergic reactions, stopping allergies, neutralizing toxic and poisonous insect and animal bites and stings, etc.”
• “Echinacea Tonic also contains Garlic, one of the strongest medicinal plants on earth. It is a supreme infection fighter capable of killing all bacteria, virus and fungus on contact. Garlic is also a very powerful anti-viral agent. Garlic destroys on contact the viral infections of Measles, Mumps, Mononucleosis, Chicken pox, Herpes simplex, Herpes zoster, Viral Hepatitis, Scarlet fever, Rabies, and others.”
High Blood Pressure II
• Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent high blood pressure.
• Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia.
Your Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula 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)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 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 Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula 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, your Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula products 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Lakisha N. Morton, Compliance Officer, 60 – 8th Street NE, Atlanta, GA 30309 or via email at firstname.lastname@example.org (preferred method). Should you send your response via hardcopy to the mailing address indicated, send an email notification to Mrs. Morton indicating that the response was mailed. Please reference CMS Case number 646193. If you have questions concerning this letter, you may contact Mrs. Morton at 404-253-1285, at email@example.com, or write her at the noted mailing address.
Ingrid A. Zambrana
Program Division Director
Office of Human and Animal Foods
Division East III