WARNING LETTER
Natural Sprout Co. LLC
MARCS-CMS 610151 —
October 29, 2020
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Stephen F. Aton
Recipient Title
Member
Natural Sprout Co. LLC
1571 E. Cherokee Street
Springfield
,
MO
65804
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
October 29, 2020
Reference: CMS 610151
WARNING LETTER
Dear Mr. Aton:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at Internet addresses www.natsprout.com and https://stmarcusorganics.com in September 2020. Your website www.natsprout.com directly links to https://stmarcusorganics.com, from which you take orders for the products Alfalfa Sprout Powder, Alfalfa Sprout Powder Capsules, Barley Sprout Powder, Barley Sprout Powder Capsules, Broccoli Sprout Powder, Broccoli Sprout Powder Capsules, Buckwheat Sprout Powder, Buckwheat Sprout Powder Capsules, Fenugreek Sprout Powder, Fenugreek Sprout Powder Capsules, High Antioxidant Blend Sprout Powder, High Antioxidant Blend Sprout Powder Capsules, Mung Bean Sprout Powder, Mung Bean Sprout Powder Capsules, Oat Sprout Powder, Oat Sprout Powder Capsules, Soy Sprout Powder, Soy Sprout Powder Capsules, Spelt Sprout Powder, and Spelt Sprout Powder Capsules. 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:
Alfalfa Sprout Powder and Alfalfa Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Alfalfa may help reduce cholesterol…”
“Health Benefits: Blood Pressure Control…Migraine Control…”
From www.natsprout.com, Technical Specification Sheet for alfalfa:
“Potential Benefits…Cholesterol reducing capacity…”
Barley Sprout Powder and Barley Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Barley may help regulate blood sugar levels and reduce the risk for heart disease.”
“Health Benefits: Cholesterol Reducing…”
From www.natsprout.com, Technical Specification Sheet for barley:
“Potential Benefits…Cholesterol reducing…”
Broccoli Sprout Powder and Broccoli Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Broccoli contains sulforaphane which is believed to inhibit tumor growth…”
“Health Benefits: Anti-Cancer, Anti-Inflammatory, Blood Pressure Control…”
From https://stmarcusorganics.com, Benefits page:
“Health benefits of out [sic] best seller – broccoli; Anti-Cancer…Cholesterol Reducing…”
Buckwheat Sprout Powder and Buckwheat Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Buckwheat…may be beneficial for those with high blood pressure or Type II Diabetes.”
From www.natsprout.com, Technical Specification Sheet for buckwheat:
“Potential Benefits: Considered as potential therapy to treat diabetes, hypercholesterolemia, hypertension, and cardiovascular disorder.”
Fenugreek Sprout Powder and Fenugreek Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“[M]ay decrease inflammation for those with arthritis…”
From www.natsprout.com, Technical Specification Sheet for fenugreek:
“Potential Benefits…Currently under study for reduction of cholesterol and blood sugar…”
High Antioxidant Blend Sprout Powder and High Antioxidant Blend Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Health Benefits: Anti-Cancer…”
Mung Bean Sprout Powder and Mung Bean Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Contains protease inhibitors believed to inhibit tumor cells.”
Oat Sprout Powder and Oat Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“The beta glutens in oats can reduce cholesterol…”
“Health Benefits…Cholesterol Reducing…”
From www.natsprout.com, Technical Specification Sheet for oat:
“Potential Benefits: Cholesterol reducing…”
Soy Sprout Powder and Soy Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Soy … may help reduce cholesterol.”
From www.natsprout.com, Technical Specification Sheet for soy:
“Potential Benefits…Anti-fungal properties…”
Spelt Sprout Powder and Spelt Sprout Powder Capsules
From https://stmarcusorganics.com, product pages:
“Spelt may…reduce risk of blood clots.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 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 Alfalfa Sprout Powder, Alfalfa Sprout Powder Capsules, Barley Sprout Powder, Barley Sprout Powder Capsules, Broccoli Sprout Powder, Broccoli Sprout Powder Capsules, Buckwheat Sprout Powder, Buckwheat Sprout Powder Capsules, High Antioxidant Blend Sprout Powder, High Antioxidant Blend Sprout Powder Capsules, Mung Bean Sprout Powder, Mung Bean Sprout Powder Capsules, Oat Sprout Powder, Oat Sprout Powder Capsules, Soy Sprout Powder, and Soy Sprout Powder Capsules 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 these products safely for their intended purposes. Accordingly, Alfalfa Sprout Powder, Alfalfa Sprout Powder Capsules, Barley Sprout Powder, Barley Sprout Powder Capsules, Broccoli Sprout Powder, Broccoli Sprout Powder Capsules, Buckwheat Sprout Powder, Buckwheat Sprout Powder Capsules, High Antioxidant Blend Sprout Powder, High Antioxidant Blend Sprout Powder Capsules, Mung Bean Sprout Powder, Mung Bean Sprout Powder Capsules, Oat Sprout Powder, Oat Sprout Powder Capsules, Soy Sprout Powder, and Soy Sprout Powder Capsules 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)].
The violations cited in this letter are not intended to be an all-inclusive list 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 limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that 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 (15) 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 response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Bruce E. Taylor, Compliance Officer. If you need additional information or have questions concerning any products distributed through your website, please contact CO Taylor at
913-495-5114
or at the above address or via email at: bruce.taylor@fda.hhs.gov.
Sincerely,
/S/
Cheryl A. Bigham
District Director, Kansas City District Office
Program Division Director
Office of Human and Animal Food
Operations Division West II
Content current as of:
11/10/2020
Regulated Product(s)
Drugs