Source: https://www.casewatch.net/fdawarning/prod/2008/goosefoot.shtml
Timestamp: 2019-04-25 05:45:44+00:00

Document:
FDA Warning Letter to Goosefoot Acres, Inc.
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.
• 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.
• 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.
• 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."
• 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'."
• 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)].
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.html1. 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.
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.html2. 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.

References: § 321
 § 321
 § 321
 § 355
 § 352
 § 343