Inspections, Compliance, Enforcement, and Criminal Investigations
Gilroy Spice Company 12/12/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
VIA OVERNIGHT MAIL
Delivery Signature Required
December 12, 2011
Lawrence W. Doyle, Jr., Owner
Gilroy Spice Company
625B San Juan Hollister Road
San Juan Bautista, California 95045
Dear Mr. Doyle, Jr.:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified canned food manufacturing facility, located at 625B San Juan Hollister Road, San Juan Bautista, California, on June 27 and 28, 2011, July 20, 2011 and July 27, 2011. As a result of the inspection as well as a review of your websites, www.gilroyspice.com and www.garliccapitalproducts.com, FDA found serious violations of the Federal Food Drug and Cosmetic Act (FFDCA). You may find the Act and FDA regulations through links at FDA’s home page at http://www.fda.gov.
Under section 201(g)(1)(B) of the FFDCA [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 made on your website at www.gilroyspice.com and www.garliccapitalproducts.com, we have determined that your Garlic Capital products, Gilroy Hot Stuff products, Zesty Garlic Salsa products, and Unique Garlic Appetizer products are promoted for conditions that cause these products to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the FFDCA.
Examples of some of the claims observed on your website include the following. The claims concern garlic, an ingredient in your products:
From the main web page under the subtitle “Health”:
- “New Scientist Magazine has the results of a very interesting new garlic study from [N]ew Zealand, in a story called ‘A Clove a Day Keeps Cancer at Bay’”
- “[A] comprehensive 1999 summary of scientific evidence about garlic and health. This includes … cancer … Well documented with a bibliography and abstracts of supporting studies.”
- “Garlic and Cancer Prevention From the Mayo Clinic”
These claims indicate that your garlic products are intended for the prevention, mitigation, and treatment of a disease. Because of these intended uses, the products are drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Your products are not generally recognized as safe and effective for the above-referenced uses and, therefore, are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug 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.
When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. Your website refers to study results contained in a story published in New Scientist Magazine entitled, “A Clove a Day Keeps Cancer at Bay.” This is an example of a publication that is used to market your products for disease treatment and prevention and is thus evidence of your products’ intended use as a drug.
Furthermore, your garlic products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
Food Labeling Violations
Even if the drug claims were removed from your website and your products are considered food, your products are in violation of the FFDCA with respect to food labeling. During the inspection, our investigator also collected labels of your Garlic Habanero Hot Sauce product. Based on our review, we have determined that your Garlic Habanero Hot Sauce is misbranded as follows:
- Your Garlic Habanero Hot Sauce product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that your label fails to completely declare all of the ingredients used by your firm in the production of this hot sauce in accordance with 21 CFR 101.4(a)(1). According to the product formula collected during the inspection, your product does not list the following ingredients: salt, citric acid, sodium benzoate (with technical or functional effect in food) and dehydrated vegetables (garlic, onion, cilantro). Furthermore, it was noted during the inspection that your product does not contain “garlic” as declared in the ingredient statement. Rather, the product is made with “Granulated Garlic”, “Minced Garlic (dried)” and dehydrated garlic as part of the South of the Border Mix. Your firm must declare these garlic ingredients by the appropriate common or usual name.
- Your Garlic Habanero Hot Sauce product is further misbranded within the meaning of Section 403(i)(2) because you fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(1). Specifically, your hot sauce is labeled to contain: “Habanero…” The term “Habanero” alone is not an appropriate common or usual name.
The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
The above violations are not intended to be an all-inclusive list of the violations at your facility or with your product labeling. It is your responsibility to ensure that your products are in compliance with applicable statutes and regulations enforced by FDA. You should take prompt actions to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
You should respond in writing within fifteen (15) working days from the date you receive this letter. Your response should include each step taken or that will be taken to correct these violations and prevent recurrence. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for the delay and state when you will correct any remaining violations.
In addition to the above violations, we have the following comment. Your net quantity of contents should be declared in terms of weight designated in the U.S. Customary and in metric terms [21 CFR 101.105 (p)].
Your written response should be directed to:
Darlene B. Almogela
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
Refer to the Unique Identification Number (CMS case 223655) when replying. If you have any questions about the content of this letter, please contact Mr. Lawton W. Lum, Compliance Officer, at (510) 337-6792.
Barbara J. Cassens