FDA Warning Letter to Caudill Seed & Warehouse Inc 4/14/17

April 30, 2019

 

   

 
 
Cincinnati District Office

Central Region

6751 Steger Drive

Cincinnati, OH 45237

Telephone: (513) 679-2700

FAX: (513) 679-2772

 

April 14, 2017
 
WARNING LETTER
CIN-17-512640-05
 
VIA UPS
 
Dan Caudill
Caudill Seed & Warehouse Inc.
1402 West Main Street
Louisville, KY 40203
 
Dear Mr. Caudill,
        
 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet address http://www.cs-health.com in March 2017 and has determined that you take orders there for the product Vitalica. We have also reviewed your website at the Internet address http://www.glucormed.com, which you link to from your website http://www.cs-health.com where this product can be purchased directly. The claims on your websites establish that your product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product 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
http://www.fda.gov.
 
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
 
On the “What is Vitalica” webpage, http://www.cs-health.com/what-is-vitalica:
  • “Studies have shown they may be effective in counteracting
 inflammation, carcinogenesis, and damage from UV radiation”,
  • “ [N]ovel candidates for use in cancer chemoprevention,
  • “Sulforaphane (SFN) 
First identified in 1992 as a potential chemopreventive agent,  
  • “Protecting the skin from harmful UV radiation.”
On the “How it Works” webpage, http://www.cs-health.com/how-it-works:
  • “Sulforaphane 
 inhibition of enzymes involved in carcinogen activation 
 other mechanisms of Chemoprotection by Sulforaphane”, 
  • “Eradication of Infection: Although many studies with SFN have focused on detoxification of chemical carcinogens, evidence also has been reported for protective effects against viral or bacterial pathogens”,
  • “[T]he effects of SFN on cell viability were described in HT-29 human colon cancer cells, where 100 ÎŒM SFN for 24 or 48 h resulted in a decrease in cell viability 
 Similar responses have been observed in human prostate cancer cells after treatment with SFN,”
  • “Inhibition of Recurrence: Accumulating evidence suggests that SFN is a highly promising dietary preventive agent, due to its ability to confer Chemoprotection. 
On the “The Science” webpage, www.cs-health.com/science, you provide a link to directly download a PDF, “Science and Product Safety.”
 
On the “BroccoRaphanin” PDF:
  • “Inhibit Malignant Progression of Lung Adenomas Induced by Tobacco,”
  • “Sulforaphane and skin Tumors,”
  • “Isothiocyanates as Cancer Chemopreventive Agents,”
  • “Sulforaphane Protects Against UV light-induced skin carcinogenesis.” 
On the “New research indicates consumption of broccoli sprouts may reduce high blood pressure, risk of heart disease, stroke” PDF:
  • “glucoraphanin, also known as sulforaphane glucosinolate (SGS(TM)), a naturally-occurring compound found in broccoli sprouts and broccoli, may reduce risk of high blood pressure, cardiovascular disease and stroke,”
  • “can correct major dysfunctions such as hypertension and stroke,”
  • “reduce their risk of cardiovascular disease.”
On the “PDF Library” webpage, www.gluco-rmed.com, you provide links to several studies:
  • “ [B]roccoli sprouts as inducers of carcinogen-detoxifying enzyme systems”
a.  “small amounts of cruciferous vegetable sprouts may be just as protective against cancer,”
b.  “no doubt that sulforaphane does 
 inhibit carcinogenesis.”
  • “ [C]hemoprotective glucosinolates and isothiocyanates of Broccoli Sprouts; metabolism and excretion in humans”:
a.  “protect animals against chemically induced cancer.”
  • “ [A]nticarcinogenic activities of sulforaphane and structurally related synthetic morbornyl isothiocyanates”:
a.  “sulforaphane could block chemical carcinogenesis.”
  • “ [S]ulforaphane and it metabolite mediate growth arrest and apaptosis in human prostate cancer cells”:
a.  “[R]educed prostate cancer occurrence,”
b.  “[R]eported to reduce the risk of human cancer of the lung, stomach, colon, rectum, and kidney.”
 
Your Vitalica product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 335(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).  â€œAdequate 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 Vitalica product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Furthermore, your product is intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves 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 product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
The above violations are not meant to be an all-inclusive list of violations in connection with your product or its labeling. It is your responsibility to ensure that your products and labeling comply with the Act and its implementing regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction. 
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future.  Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which you will complete the corrections.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA.  Your written response should be sent to Compliance Officer Stephen J. Rabe.  If you have any questions about this letter, please contact Mr. Rabe at 513-679-2700 extension 2163, or by email at [email protected].
 
Sincerely,
/S/ 
Steven B. Barber
District Director
Cincinnati District

This page was posted on April 30, 2019.