| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94501-7070 Telephone: (510) 337-6700 |
Department of Health and Human Services
VIA UPS
OVERNIGHT DELIVERY
WARNING LETTER
September 15, 2011
Mr. Louis Rossetto, CEO
TCHO Ventures, Inc.
Pier 17
San Francisco, CA 94111
Dear Mr. Rossetto,
The Food and Drug Administration (FDA) reviewed your website at the internet address www.tcho.com in September 2011. FDA’s review of your website found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act), as discussed in detail below.
Further, FDA conducted an inspection of your facility, located at Pier 17, San Francisco, CA, from May 17 to May 24, 2011. During the inspection, our investigators observed a serious violation of the Current Good Manufacturing Practice (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110. This violation causes the chocolate products manufactured at your facility to be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
You may find the Act and FDA regulations through links at FDA’s home page at http://www.fda.gov
Unapproved New Drugs
Based on our review of your website, we have determined that your chocolate products, including your TCHO-A-DAY product line, are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that your chocolate products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of claims on your website include the following:
From your homepage under the heading “Chocolates” and the sub-heading “Healthy Chocolate”:
TCHO-A-DAY 30, 60, and 90
- “A growing body of scientific research has shown dark chocolate has a wide range of health benefits relating to: . . . diabetes, anti-inflammatory effects . . . tooth decay.”
Your website makes further claims with respect to dark chocolate and chocolate in general, including but not limited to the following:
From your homepage under the heading “Blog” and the sub-heading “The Mind of TCHO”:
- “[C]hocolate lowers blood pressure.”
- “[D]ark chocolate . . . helps decrease blood pressure”
- “Dark Chocolate May Help Reduce Dangers For Cirrhosis Patients”
- “[E]ating certain kinds of chocolate may actually prolong the lives of people with cirrhosis and other forms of advanced liver disease.”
- “Dark Chocolate . . . can help alleviate . . . depression . . . .”
- “Heart-attack survivors who ate chocolate just twice a week . . . cut their risk of dying from heart disease threefold.”
From your homepage under the heading “Blog” and the sub-heading “Chocolate and Health”:
- “[D]ark Chocolate May Guard Against Brain Injury From Stroke”
- “Chocolate . . . lower[s] blood pressure, study finds.”
- “Cocoa can decrease blood pressure”
- “Chocolate protects against cardiac mortality following myocardial infarction”
Furthermore, your TCHO 30 label on the website bears a “Good Drug Facts” panel which lists the following active ingredients: Theobromine, Trytophan [sic], Flavanols, Phenethylamine [sic], and Love.
In addition, your website references and links to numerous scientific studies on the relation of chocolate and cognition, antioxidant activity, behavior, bioavailability, blood pressure, cardiovascular health, anti-inflammation, diabetes, immune health, and dermatology.
When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. The following are examples of reference citations used to market your product for disease treatment and prevention on your website and are thus evidence of your products’ intended use as drugs:
From your homepage under the heading “Chocolates” and the sub-heading “Healthy Chocolate”:
- “Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic patients: a double-masked, randomized, controlled trial. Journal of American College of Cardiology. June 2008; 51(22): 2141-2149. Balzer, J., Rassaf, T., Heiss, C., Kleinbongard, P.”
- “Effects of cocoa flavanols on risk factors for cardiovascular disease. Asia Pacific Journal of Clinical Nutrition. 2008. 17 Suppl 1: 284-287. Erdman, J., Carson, L., Kwik-Uribe, C., Evans, E., Allen, R.”
The claims listed above establish that your products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” as defined by section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted to a drug sponsor to demonstrate that the drug is safe and effective.
Misbranded Drugs
Because your chocolate products are being offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Thus, your product labeling fails to bear adequate directions for the products’ intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act, [21 U.S.C. § 331(a)].
Misbranded Food
Your chocolate products are further misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] because their labeling bears health claims that have not been authorized by regulation or the Act. Your website, www.tcho.com, bears the following unauthorized health claims:
From your homepage under the heading “Blog” and the sub-heading “The Mind of TCHO”:
- “Chocolate’s protective natural substances . . . help prevent cholesterol from sticking to your artery walls, reducing your risk of heart attack and stroke.”
From your homepage under the heading “Blog” and the sub-heading “Chocolate and Health”:
- “Chocolate reduces the risk of stroke or heart attack by increasing flow of blood around the brain . . . .”
This health claim misbrands your product because it has not been authorized either by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]].
CGMP Violation
Your firm failed to clean, as frequently as necessary, all food contact surfaces, including utensils and food-contact surface of equipment, to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically, our investigator observed hardened chocolate from a previous day’s production on the milk chocolate hopper and chocolate depositor. Both of these pieces of equipment were used to manufacture ready-to-eat chocolate products during our inspection without prior cleaning.
The above violations are not meant to be an all-inclusive list of violations at your facility or deficiencies in your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and any other labeling or promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. We also advise you to address your recurring CGMP violation.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If all corrective actions cannot be completed within fifteen working days, please state the reason for the delay and the time within which the corrections will be completed.
Your written response should be directed to Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Brandon L. Bridgman, Compliance Officer at 510-337-6794.
Sincerely,
/S/
Barbara J. Cassens
Director
San Francisco District
U.S. Food and Drug Administration
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