Michelle's Miracle, Inc. 6/8/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
June 8, 2012
Michelle White, President
Michelle’s Miracle, Inc.
5355 N. Manitou Trail, W
P.O. Box 516
Leland, MI 49654-9711
Dear Ms. White:
The U.S. Food and Drug Administration (FDA) reviewed your website at http://www.michellesmiracle.com in June, 2012. Based on a review of your website, FDA has determined that the following products are promoted for conditions that cause the products to be drugs within the meaning of section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]:
- Michelle’s Miracle® Joint Formula Tart Cherry Concentrate Dietary Supplement
- Michelle’s Miracle® Original Tart Montmorency Cherry Concentrate Dietary Supplement
- Michelle’s Miracle® Sleep Formula Tart Cherry Concentrate Dietary Supplement
- Michelle’s Miracle® Tart Cherry CherriMax Dietary Supplement
The therapeutic claims on your website establish that the above products (referred to as “your tart cherry concentrate products” in the rest of this letter) are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. The marketing of your tart cherry concentrate products with these claims violates the FD&C Act. You can access the FD&C Act and its implementing regulations from links on FDA’s homepage www.fda.gov
Examples of some of the therapeutic claims observed on your website include:
From the webpage entitled “Making Miracles in the Heart of Cherry Country:
- “[Michelle White]observed seniors looking for tart cherry juice to help relieve gout, arthritis and joint pain. . . . [T]here is considerable scientific evidence to support the anti-inflammatory . . . benefits of tart cherries".
From the webpage entitled “Michelle’s Story”:
- “[O]lder people had been coming to the fruit-processing plant asking for jugs of cherry concentrate . . . . All of these people claimed that the Montmorency tart cherry concentrate significantly relieved the pain and swelling of arthritis.”
From the webpage entitled “Anthocyanins and Heart Health”:
- “Recent studies indicate the powerful antioxidants in cherries, known as anthocyanins, may play a role in reducing inflammation and risk factors for heart disease.”
- “The anthocyanins in tart cherries, at a concentration of 10µM, inhibited COX enzymes comparable to ibuprofen and naproxen.”
From the webpage entitled “Fighting Pain With Tart Cherries”:
- “Fighting Pain With Tart Cherries”
- “[T]esting by Brunswick Labs revealed that tart cherries significantly inhibit the COX enzyme . . . . Two tablespoons of tart cherry concentrate is equivalent to .30 grams of aspirin; whereas, a standard aspirin tablet is .325 grams.”
From the webpage entitled “Fighting Inflammation With Tart Cherries”:
- “Fighting Inflammation With Tart Cherries”
- “Cherries contain flavonoid compounds that lower uric acid and . . . help modulate inflammation. Cherry juice concentrate has been shown to be extremely effective in reducing the minor pain associated with joint problems.”
From the webpage entitled “Cherries: The Healthy Fruit”:
- “[T]here are beneficial compounds in Montmorency tart cherries that help relieve minor pain associated with joint problems.”
- “[M]any consumers are discovering that tart cherry juice and other cherry products can stave off minor joint pain.”
From the webpage entitled “Tart Cherry Concentrate-Powerful and Delicious”:
- “Tart Montmorency Cherry Concentrate: . . .
- Supports inflammatory response”
From the webpage entitled “Tart Cherry Concentrate Joint Formula-Support and Maintain Healthy Joints”:
- “Our super-premium Joint Formula Tart Cherry Concentrate . . . contain[s] . . . Cinnamon, an ancient spice with known anti-inflammatory properties.”
Your webpage entitled “Tart Cherries and Health” also includes links to other websites that describe the use of tart cherries and tart cherry juice to prevent and treat various diseases. The claims accessed through these links provide additional evidence that your tart cherry juice concentrate products are intended for use as drugs. For example, the “Tart Cherries and Health” webpage includes a link to the National College of Natural Medicine’s “Tart Cherries Summary of Current Scientific Literature” (http://www.ncnm.edu/images/Helfgott/Projects/scientific-literature-summary-cherries-2011.pdf), which contains the following statements about the use of tart cherry products in preventing and treating cancer and cardiovascular disease:
- “[N]ew research . . . shows why we should be drinking tart cherry juice. The reasons are as follows: . . . encouraging positive effects against cancer such as reducing tumor burden in parts of the gut and slow[ing] tumor growth.”
- “[I]solated anthocyanins, the tart cherry compound that gives it its color and disease-fighting power, reduce . . . obesity, and hardening of the arteries.”
- “Dietary Anthocyanin-Rich Tart Cherry Extract Inhibits Intestinal Tumorigenesis in . . . Mice Fed Suboptimal Levels of Sulindac.”
- “The researchers studied whether or not adding tart cherry extract (containing anthocyanins) to sulindac would block cancer growth even more powerfully. The mice that got both . . .tart cherry and sulindac had fewer small gut tumors and smaller total tumor mass . . . . It seems that the tart cherry juice may be working on a different part of the small gut than sulindac. This might explain how tart cherry works with this medication to decrease tumor burden all across the gut.”
Your webpage entitled “Tart Cherries and Health” also includes a link to the website http://www.choosecherries.com, which contains the following treatment claims, among others:
- “A growing body of science links cherries’ red color provided by the fruit’s powerful antioxidants – called anthocyanins – to heart-health benefits related to reducing inflammation [and] total cholesterol . . . .”
- “Even more good news: research also suggests the red compounds in cherries may help ease the pain of arthritis and gout.”
- “Recent studies indicate the powerful antioxidants in cherries . . . may play a role in reducing inflammation and risk factors for heart disease.”
Your tart cherry concentrate 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 FD&C 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 FD&C 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.
In addition, your tart cherry juice concentrate products are being offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use these products safely for their intended uses. Accordingly, the products are also misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)], in that their labeling does not bear adequate directions for use.
Even if your tart cherry juice concentrate products were not marketed with disease prevention and treatment claims that cause them to be drugs, they would still be misbranded as dietary supplements. Under section 403 of the Act [21 U.S.C. § 343] because their labeling contains false and misleading claims that the products are fresh and nutrient content claims that do not meet the requirements of the regulations authorizing such claims.
Specifically, your tart cherry juice concentrate products are misbranded under section 403(a)(1) of the FD&C Act [21 U.S.C. § 343(a)(1)] in that their labeling is false and misleading. The webpages entitled “Tart Cherry Concentrate-Sleep Formula,” “Tart Cherry Concentrate-Joint Formula,” and “Tart Cherry Concentrate” at www.michellesmiracle.com bear the statement “Always fresh from the farm to the bottle.” However, these webpages also bear the statement “flash-pasteurized to preserve the rich flavor and potency of the cherries,” indicating that the products have been preserved via thermal processing. In addition, the labels of these products identify them as concentrates, and an FDA inspection of the manufacturer of your tart cherry juice concentrate products, Triple D Orchard, Inc., revealed that these products are made from frozen tart cherry concentrate. Under 21 CFR 101.95, the term "fresh," when used on the label or in labeling of a food in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation. Because your products are made from frozen pasteurized tart cherry concentrate, they do not meet the requirements for a “fresh” claim and, therefore, the labeling of these products is false and misleading.
Your tart cherry juice concentrate products are also misbranded under section 403(r)(1)(A) of the FD&C Act [21 U.S.C. § 343(r)(1)(A)] because your website makes the following nutrient content claims about the levels of antioxidants in the products:
From the webpage entitled “Cherries: The Healthy Fruit”:
- “Montmorency tart cherries are a rich source of antioxidants . . . .”
From the webpage entitled “Higher ORAC Than Pomegranate or Acai”:
“In April 2005 the Cherry Marketing Institute announced results of a recent research project funded by a U.S. Department of Agriculture Rural Development Grant that confirm the presence of powerful antioxidants, in exceptionally high amounts, in tart cherry products.”
From the webpage entitled “Tart Cherry Concentrate--Powerful and Delicious”:
- “A Delicious . . . Nutraceutical Loaded with Antioxidant Activity . . .”
Under 21 CFR 101.13(b), a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food is a nutrient content claim. Like health claims, nutrient content claims must be made in accordance with the regulations authorizing the use of such claims [21 U.S.C. § 343(r)(1)(A); 21 CFR 101.13(b)]. Nutrient content claims using the term “antioxidant” must comply with, among others, the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear an antioxidant claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(1)], and these nutrients must have recognized antioxidant activity [21 CFR 101.54(g)(2)]. The level of each antioxidant nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) [21 CFR 101.54(g)(3)]. For example, to bear the claim “rich in antioxidant vitamin C,” the product must contain 20 percent or more of the RDI for vitamin C [21 CFR 101.54(b)]. A nutrient content claim for an antioxidant nutrient or nutrients must also include, as part of the claim, the name(s) of the nutrient(s) that are the subject of the claim; alternatively, the term “antioxidant” or “antioxidants” in the claim may be linked to the antioxidant name(s) by a symbol (e.g., an asterisk) that refers to the same symbol elsewhere on the same panel of the product label, followed by the name(s) of the nutrient(s) with recognized antioxidant activity [21 CFR 101.54(g)(4)]. The quoted claims from your website are nutrient content claims because they characterize the levels of the antioxidants in your products, and antioxidants are nutrients of the type required to be in nutrition labeling [21 CFR 101.13(b); see 21 CFR 101.36(b)(2)-(3)]. However, these claims do not comply with 21 CFR 101.54(g)(4) because they do not include the names of the nutrients that are the subject of the claim or link the nutrient names to the claim by the use of a symbol.
The violations cited above are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for ensuring that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in legal action, such as seizure and/or injunction, without further notice.
In addition to the violations cited above, we have the following comment about your labeling:
The “Tart Cherries and Health” page of your website bears the health claim, “According to the U.S. Food and Drug Administration, diets rich in fruits and vegetables may reduce the risk of some types of cancer . . . .” However, we note that your products do not appear to meet the requirements to bear a health claim about the relationship between fruits and vegetables and reduced cancer risk under 21 CFR 101.76 or 101.78.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations cited in this letter. Include each step that has been taken or will be taken in the future to correct the violations and prevent their recurrence, as well as copies of any documentation necessary to show that corrections have been made. If you cannot complete all corrections within fifteen working days, please state the reason for the delay and the date by which the corrections will be completed.
Your response should be directed to Cicely N. Vaughn, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Vaughn at 313-393-8297.
Glenn T. Bass
Detroit District Office