Inspections, Compliance, Enforcement, and Criminal Investigations
Goosefoot Acres, Inc. 19-Nov-08
Department of Health and Human Services
Public Health Service
Cincinnati District Office
Via Federal Express
WARNING LETTER CIN-09-27728-03
November 19, 2008
Peter A. Gail, Ph.D., CEO and President
Goosefoot Acres, Inc.
3283 E. Fairfax Rd.
Cleveland Heights, OH 44118
Dear Mr. Gail:
This letter is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.dandyblend.com and has determined that the product "Dandy Blend" is promoted for conditions that cause the product to be 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)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Statements on your website that document the intended uses of this product include, but are not limited to, the following:
• "Potentially Helpful For . . .
o Diabetics . . .
o High blood pressure, high cholesterol, heart disease . . . Dandelion also is an effective diuretic with its own built in potassium . . . . This can help improve cholesterol and lower blood pressure.
o Liver and gall bladder ailments . . . Users of Dandy Blend have reported the disappearance of gall bladder problems soon after they started drinking it. One, previously diagnosed with a gall bladder problem requiring an operation, was told after drinking Dandy Blend for less than two weeks, that she no longer needed it.
o Cancer sufferers . . . Extracts of dandelion have been demonstrated to be effective against cancerous tumors. A Japanese firm has patented an extract of dandelion for that purpose."
• "Potentially Helpful For . . .
o Asthma sufferers . . . According to Dr. John Heinerman of the Medical Research Center in Salt Lake City, Utah, 'Asthma sufferers and people with airborne allergies find considerable relief by drinking warm Dandy Blend. It unclogs air passages and expands them'."
• "Potential Health Benefits
Dandy Blend, made as either a dandelion tea or a delightful herbal coffee, can benefit those suffering from high blood pressure, cholesterol, liver and gall bladder ailments, cancer and coronary artery or heart disease . . . . With its low carbohydrate content and richness in trace minerals, it also can be effective for diabetics . . . . A hot cup of Dandy Blend instant dandelion coffee can even help unclog and expand the air passages of those suffering from asthma[.]"
DandyBlend™ is a drug as defined by section 201(g)(1)(B) of 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 in man or other animals. Moreover, this product is a new drug as defined by section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use under the conditions recommended or suggested in its labeling. New drugs 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)].
Furthermore, since DandyBlend™ is 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 layperson can use the product safely for its intended uses. Thus, your product's labeling fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
Even if your DandyBlend™ product did not contain disease claims in its labeling that cause it to be a drug, it would still be misbranded as a food under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the labeling bears the nutrient content claims "mineral rich," "rich in trace minerals," "rich in potassium," and "potassium-rich," but the product does not comply with the regulations governing the use of such claims. The nutrient content claim "rich" may be made for a nutrient (such as potassium) only if the food contains 20 percent or more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) of the nutrient per reference amount customarily consumed (RACC) [21 CFR 101.54(b)]. The RACC for DandyBlend™ is 2 grams, which, according to the "Minerals of DandyBlend" page of your website, is the amount needed to make eight fluid ounces (240 mL) of the beverage [see 21 CFR 101.12(b), Table 2, "Miscellaneous Category: Drink mixers (without alcohol)"]. According to the mineral content analysis for DandyBlend™ posted on your website, your product does not contain 20 percent or more of the DRV of potassium [see 21 CFR 101.9(c)(9)] per RACC. Nor does the product contain 20 percent or more per RACC of the DRV or RDI of any of the other substances listed as "minerals" or "trace minerals" in the mineral content analysis for DandyBlend™ [see 21 CFR 101.9(c)(8)(iv)]. Additionally, authorized nutrient content claims are limited to substances that have an RDI or DRV, and there is no RDI or DRV for the remaining substances listed on your website as "minerals" or "trace minerals" present in DandyBlend™
Finally, we note that you use the claim "gluten-free" on your labeling. Under the Food Allergen Labeling and Consumer Protection Act of 2004, FDA is required to define the use of the term "gluten free," and, therefore, you should be aware that there will be specific requirements to make this claim in the future. On January 23, 2007, FDA issued a proposed rule regarding gluten-free labeling of foods [72FR 2795]. For information on FDA's proposed "gluten-free" definition and a list of grains that FDA considers to contain gluten, we recommend reviewing the proposed rule, which can be viewed online at http://www.cfsan.fda.gov/~Ird/fr070123.html. The Agency has not yet issued a final rule defining"gluten-free." In the interim, FDA is regulating "gluten-free" claims under the general misbranding provision in section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], which prohibits false or misleading statements in food labeling.
The violations cited in this letter are not intended to be an all-inclusive statement 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 and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
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. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the above 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 working days, state the reason for the delay and the time within which you will complete the correction.
Please direct your response to the U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237-3097, Attention: Karen Gale Sego, Compliance Officer.
A description of the new drug approval process can be found on FDA's Internet website at http://www.fda.gov/cder/regulatory/applications/default.html. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO51-2201, Silver Spring, MD 20993.
Toniette K. Williams
Acting Cincinnati District Director
cc: Charles Kirchner, Chief, Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399