Inspections, Compliance, Enforcement, and Criminal Investigations
Wyldewood Cellars, Inc. 27-Oct-06
Department of Health and Human Services
Public Health Service
Kansas City District
October 27, 2006
RETURN RECEIPT REQUESTED
Ref: KAN 2007-02
John A. Brewer, Ph.D., Owner
Wyldewood Cellars, Inc.
951 E. 119th St. South
Peck, Kansas 67120ss
Dear Dr. Brewer:
The Food and Drug Administration (FDA) has reviewed your firm's website at http://www.elderberry.net. Our review of your website found violations of the Federal Food, Drug, and Cosmetic Act (the Act), as described below. You can find the Act and FDA's regulations through links on FDA's Internet home page at http://www.fda.gov.
Under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. Based on claims that appear on your website for your Elderberry Juice Concentrate product, we have determined that this product is a drug under section 201(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
Examples of some of the disease claims for Elderberry-Juice Concentrate on your website include the following:
1. "Various cultures, including the Native Americans, have used the elderberry plant to treat colds, flu's [sic], asthma . . .diabetes . . .rheumatism, and nervous disorders such as insomnia and migraines . . . ."
2. "[T]he medicinal benefits of elderberries are being investigated and rediscovered (Medical Herbalism 8:41 pg,11). Bioflavinoids [sic] and other proteins in the juice destroy the ability of cold and flu viruses to infect a cell. People with the flu who took elderberry juice reported less severe symptoms and felt better much faster than those who did not. Elderberry juice was used to treat a flu epidemic in Panama in 1995 (J Alt Compl Med 1995: 1:361-69). Elderberries were listed in the CRC Handbook of Medicinal Herbs as early as 1985, and are listed in the 2000 Mosby's Nursing Drug Reference - for colds, flu, yeast infections, nasal and chest congestion, and hay fever."
3. "In Israel, [redacted] has determined that elderberry stimulates the body's immune system and they are treating cancer and AIDS patients with it."
4. "Testimonials from our customers support the historical medicinal claims . . . . The majority of the testimonials relate tremendous relief from debilitating asthma and chronic allergies."
5. "For an adult, one teaspoon of our Elderberry Juice Concentrate . . . provides a daily preventative dose for most colds and flus."
6. "A medically proven strong antiviral . . . a natural source of . . . Quercetin (anti- inflammatory and antihistamine), and Bioflavinoids [sic] (antiviral and antidiabetic), elderberry is recommended as part of a health maintenance program."
Because your product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under section 505 of the Act (21 U.S.C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). This drug is also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that its labeling does not bear adequate directions for use.
The above violations are not meant to be an all-inclusive list of 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.
The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S. .C. §§ 332 and 334]. You should take prompt action to correct the violations identified in this letter and any other violations of the Act. Failure to do so may result in enforcement action without further notice.
Please advise 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 assure that 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 the time within which the corrections. will be completed.
During the FDA inspection of your firm on March 14-16, 2006, our investigator collected a copy of the product label for Elderberry Juice Concentrate. In the event that you decide to market this product as a food by removing all disease claims about it, we are providing the following comments on other changes that would be necessary to bring the product label into compliance with the food labeling regulations.
The serving size on the Nutrition Facts panel of your label is not correct. The reference amount customarily consumed for juice is based on 8 fluid ounces of prepared juice (see 21 CFR 101.12(b) and (c)). Hence, the serving size for the unprepared elderberry juice concentrate must be the amount of concentrate that would make 8 fluid ounces. The serving size of "1 tsp" stated on this food is intended to make only 4 fluid ounces when mixed with water. As a result of this error in the serving size, the nutrition information on your label is also incorrect.
Assuming that your product contains an insignificant amount of trans fat (defined in 21 CFR 101.9(f)(1) as an amount that allows a declaration of zero in nutrition labeling), the Nutrition Facts panel must include trans fat in the "not a significant source" statement because your label makes a nutrition claim (see 21 CFR 101.9(f)(4)).
Your reply should be addressed to Nadine Nanko Johnson, Compliance Officer, at the above letterhead address.
John W. Thorsky