WARNING LETTER
Dr. Green Mom, LLC
MARCS-CMS 644546 —
January 30, 2023
Delivery Method:
Via Email
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Ashley Mayer
Dr. Green Mom, LLC
4540 E Mazatzal Dr
Cave Creek
,
AZ
85331-2207
United States
support@drgreenmom.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
RE: CMS # 644546
Dear Ms. Mayer:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.drgreenmom.com in October 2022 and has determined that you take orders there for your Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm products. Based on our review, the claims on your website establishes 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. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Act, 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the Act, 21 U.S.C. § 352. 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’s home page at
www.fda.gov.
The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving mpox.
1,2
Therefore, FDA is taking measures to protect customers from products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure mpox. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure mpox in people. We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include the following:
From a May 23, 2022 blog post entitled, “What is Monkeypox,” http://www.drgreenmom.com/what-is-monkeypox/:
“What Can I Do To Protect My Family From Monkeypox?... products like Vitamin A, Vitamin D, Zinc, Mother’s Immunity, and Immunity Boost [each of these product names links to your page selling the product] . . . help to prevent viral infections in general and *MAY* help prevent Monkeypox (we simply do not know enough to say for sure if they will offer protection).”
From a blog post entitled, “Colloidal Silver: Everything Parents Need to Know”: http://www.drgreenmom.com/colloidal-silver-everything-parents-need-to-know/:
“What Can Colloidal Silver Treat? … As an antiviral, silver can kill the virus that causes Covid-19 and may be an effective adjunctive treatment. There is also evidence that it may be effective against other viruses of interest including monkeypox, herpes, RSV, and viruses that cause upper respiratory tract infections (like influenza).”
“Colloidal silver is an effective antimicrobial that can be helpful in treating bacterial, viral, and fungal infections.”
On the product webpage for “Vitamin D3 (400IU)”: http://www.drgreenmom.com/shop/vitamin-d3/
“Neuroimmune Vitamin D3 (400IU) is a micellized vitamin formula used for…disease prevention like autoimmune and cancer.”
“Alleviates Cold/Flu”
“Alleviates Depression”
In addition, FDA is particularly concerned that your market your Colloidal Silver product for use in infants and children. For example, your blog post “Colloidal Silver: Everything Parents Need to Know” states that “Dr. Green Mom Colloidal Silver tastes like water and is easy to give to even the pickiest kids.” Your products have not been evaluated by FDA for safety, effectiveness, and quality. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations such as children and infants who may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
Your Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm 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. 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 Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm 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 product safely for their intended purposes. Accordingly, your Vitamin A, Vitamin D, Liquid Zinc, Immunity Boost, Mother’s Immunity, and Colloidal Silver 15ppm 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.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. 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. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Sara Dent Acosta, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
____________________________
1
Secretary of Health and Human Services, Renewal of Determination that a Public Health Emergency Exists (issued Nov. 2, 2022), available at
https://aspr.hhs.gov/legal/PHE/Pages/mpx-renewal-2Nov2022.aspx
.
2
HHS has adopted the World Health Organization’s renaming of monkey pox to “mpox” to reduce stigma. Department of Health and Human Services, Biden Harris Administration Supports the World Health Organization Renaming of Monkeypox to mpox (issued Nov. 28, 2022), available at
https://www.hhs.gov/about/news/2022/11/28/biden-harris-administration-supports-the-world-health-organization-renaming-of-monkeypox-to-mpox.html
.
Content current as of:
01/31/2023
Regulated Product(s)
Drugs
Food & Beverages