WARNING LETTER
Chambers' Apothecary
MARCS-CMS 636306 —
November 14, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Robert Norris
Chambers' Apothecary
278 Lincoln Way
East Chambersburg
,
PA
17201
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
November 14, 2022
RE: CMS# 636306
Dear Mr. Robert Norris:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.chambersapothecary.com in October 2022 and has determined that you take orders there for your Blood Pressure Support and CoEnzyme Q10 products. The claims on your websites 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’s 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 the following:
On your Blood Pressure Support product page at https://www.chambersapothecary.com/product/bloodpressure-support/:
“In regard to the herbal blend, research suggests Hawthorn extract (Crataegus oxyacantha) [an ingredient in Blood Pressure Support] may help control high blood pressure and cholesterol by increasing coronary artery blood flow and improving circulation. Coleus forskohlii [an ingredient in Blood Pressure Support] contains a chemical called forskolin, which is known for having the ability to reduce blood pressure. Hops strobiles (Humulus lupulus) [an ingredient in Blood Pressure Support] contains specific flavonoids that have the potential to lower blood pressure... Taurine [an ingredient in Blood Pressure Support] is a naturally occurring amino sulfonic acid and may lower blood pressure ....”
On your CoEnzyme Q10 product page at https://www.chambersapothecary.com/product/coq10-100mg-120-ct/:
“May lower cholesterol”
“May decrease muscle breakdown, pain and discomfort for people taking statins.”
“May lower blood pressure”
“May improve health of blood vessels in those with ... heart disease.”
Your Blood Pressure Support and CoEnzyme Q10 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 products Blood Pressure Support and CoEnzymeQ10 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, Blood Pressure Support and CoEnzymeQ10 fail to bear adequate directions for their intended uses 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 these matters 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 products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Dr. Aaron Dotson, 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
Food and Drug Administration
Content current as of:
11/17/2022
Regulated Product(s)
Dietary Supplements
Drugs