| UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION BUREAU OF CONSUMER PROTECTION WASHINGTON, D.C. 20580 | DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION COLLEGE PARK, MD 20740 |
November 22, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 10
Mr. Michael Larsen
CocoKefir LLC
716 Tower Drive
Medina, MN 55340
Dear Mr. Larsen:
This is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at www.cocokefir.com in July 2011. FDA has determined that your “CocoKefir” products are promoted for conditions that cause them to be 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)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), aff’d, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat'l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), aff’d, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, slip op. 18-20, 2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009) (http://www.ftc.gov/os/adjpro/d9329/091224commissionopinion.pdf), pet. for review den., 2010 WL 5108600 (D.C. Cir. Dec. 10, 2010).
Examples of some of the claims observed on your www.cocokefir.com website include:
From the “Product” link under the headings titled, “Science and Links” and “Science and Links about Gut Health & Probiotics”:
•“In people with sensitive neurological systems (such as people with autism) the imbalance [in probiotics] can result in dramatic effects on neurological function. When treated consistently over time with probiotics … disease symptoms can be reversed.”
From the “Tula’s Story” link under the heading titled, “Tula’s Story – Antibiotics, Autism, and Cocokefir”:
•“By gradually increasing the dose [of CocoKefir™], we minimized the effects of the "die off" and slowly brought Tula out of the fog of autism.”
• “[CocoKefir] play[ed] a key role in healing her gut which ultimately was a major key to her recovery [from autism].”
•“Since everyone in the family began eating healthier and drinking young coconut kefir, we have all been healthy and colds and flu's have been short in duration with milder symptoms. Recurring cold sores and other mouth sores have all but dissappeared [sic]. … Ear infections are a thing of the past, acid reflux has been improved, UTI's are gone …”
Your website also contains disease claims in the form of personal testimonials, including:
From the “Product” link under the heading titled “Testimonials”:
• “I was diagnosed with Ulcerative Colitis {inflammation of the large intestine} 5 years ago and have tried everything under the sun to keep my symptoms under control … I would say hands down that CocoKefir keeps my colon happy and it's something I simply cannot live without.”
•“I've been drinking CocoKefir for the past couple of months … I'm 49 years old and have struggled with Crohn's disease since around the age of 12 … In a nutshell, this stuff rocks. Seriously, I've spent a great deal of time and money on alternatives and have experienced benefits from other methods, but this stuff rocks.”
Your CocoKefir 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 marketed in the U.S. 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 by a drug sponsor to demonstrate that the drug is safe and effective.
Your CocoKefir products are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fails to bear adequate directions for use.
Labeling Violations
FDA has determined that your CocoKefir™ Young Coconut Kefir product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the Nutrition Facts panel shown on your website fails to properly declare the serving size as required by 21 CFR 101.9(b) and 101.12(b). Specifically, serving sizes are determined based on the Reference Amounts Customarily Consumed (RACC), which are provided in 21 CFR 101.12(b). The Nutrition Facts panel for your CocoKefir™ Young Coconut Kefir product declares the serving size as “1/2 cup,” but based on the RACC for beverages, the serving size is 8 oz (240 ml). Additionally, the Nutrition Facts panel for your CocoKefir™ Young Coconut Kefir product does not follow the serving size with the equivalent metric quantity in milliliters as required by 21 CFR 101.9(b)(7).
FDA has also determined that your CocoKefir™ Young Coconut Kefir product is misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the product bears a nutrient content claim but does not meet the requirements to make the claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or, by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
Your website http://www.cocokefir.com has the following nutrient content claim respecting your CocoKefir™ Young Coconut Kefir product under the “Products” link, and under the heading, “CocoKefir™ Young Coconut Kefir”:
“CocoKefir™ … Young Coconut Kefir …
•High in nutrients such as potassium … and magnesium.”
The phrase “High in nutrients such as potassium … and magnesium” meets the definition of a nutrient content claim because it characterizes the product's level of potassium and magnesium, which are nutrients of the type required to be in nutrition labeling [21 CFR 101.13(b)]. Nutrient content claims that use the defined term “high” to characterize the level of a nutrient may be used in the labeling of a food only if the food contains 20 percent or more of the Reference Daily Intake or Daily Reference Value for the nutrient per RACC [21 CFR 101.54(b)(1)]. The claim “High in nutrients such as potassium … and magnesium” does not meet the requirement for a “high” claim because your CocoKefir™ Young Coconut Kefir product does not contain 20 percent or more of the Reference Daily Intake or Daily Reference Value for potassium and magnesium. The Nutrition Facts panel on your website declares the level of potassium as 8% of the Daily Value (DV) and the level of magnesium as 6% of the DV for a serving size of a 1/2 cup. Accordingly, even at the correct RACC of 1 cup (8 oz.), the level of potassium would be 16% of the DV and the level of magnesium would be 12% of the DV.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above. 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].
FDA also notes the following in regards to your product:
•We are concerned that the brand name of the product, “CocoKefir,” may potentially be misleading because it appears to imply that the product is a dairy beverage. Use of bolding and an alternate font makes the word “Kefir” appear more prominently featured than the word “Coco.” Kefir is commonly understood to be a dairy beverage of fermented milk from cows, sheep, or goats.
•Your website includes many links to other websites which discuss probiotics and diseases. Please be aware that you are responsible for ensuring that labeling for your products, including information provided through links on your website, complies with the Act and FDA’s implementing regulations.
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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Ms. Melissa I. Michurski, Compliance Officer, Food and Drug Administration, 250 Marquette Ave., Suite 600, Minneapolis, MN 55401. If you have any questions regarding any issue in this letter, please contact Ms. Michurski at 612-758-7185.
In addition, FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. This includes not only the claims appearing on the Internet website identified above, but also to the following claim appearing in your advertisement found in Sky magazine (May 2011, page 95) made available to passengers on Delta airlines:
•“Founded by parents who recovered their daughter from autism through diet and gut healing…see Tula’s story of recovery at www.cocokefir.com”
Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require that you pay back money to consumers. Please notify FTC via electronic mail at healthproducts@ftc.gov, within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Richard Cleland at 202-326-3088.
Sincerely,
/s/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
/s/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
/s/
Elizabeth A. Waltrip
Acting Director
Minneapolis District Office
Food and Drug Administration
cc: (b)(4)
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