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U.S. Department of Health and Human Services

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Pompeian, Inc. 2/22/10

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  College Park, MD 20740

 

FEB 22 2010


WARNING LETTER


VIA OVERNIGHT MAIL


Frank D. Patton, President
Pompeian, Inc.
4201 Pulasky Highway
Baltimore, MD 21224-1603


Re: CFSAN-OC-10-16


Dear Mr. Patton:



The Food and Drug Administration (FDA) has reviewed the label for your "Pompeian Imported Extra Light Olive Oil" product and your website www.pompeian.com. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.


Misbranded Food


Your "Pompeian Imported Extra Light Olive Oil" product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 USC § 343(r)(1)(A)] because the product label bears a nutrient content claim but does not meet the requirements to make the claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(I)(A) of he Act.


The product is labeled "Extra Light Olive Oil." The regulation governing claims using the term "light" to describe a food is found at 21 CFR 101.56. Pursuant to 21 CFR 101.56(b)(1), a nutrient content claim using the term "light" or "lite" to describe a food that derives 50 percent or more of its calories from fat may only be used on the label of the food, without further qualification, if the fat content of the food is reduced by 50 percent or more per reference amount customarily consumed (RACC) compared to an appropriate reference food as specified in 21 CFR 101.130)(1).

Your "Pompeian Imported Extra Light Olive Oil" product derives more than 50 percent of its calories from fat and, accordingly, must meet the requirements set forth in 21 CFR 101.56(b)(1) to bear a nutrient content claim containing the term "light" without further qualification. The Nutrition Facts panel for this product declares 14 g fat per RACC of one tablespoon, which is comparable to the reference food for this product as specified in 21 CFR 101.130)(1). Therefore, this product cannot be labeled with the nutrient content claim containing the term "light," without further qualification, because the fat content is not reduced by 50 percent compared to an appropriate reference food.


The term "light" may be used in a nutrient content claim on the label of a food which does not meet the requirements set forth in 21 CFR 101.56(b)(1) only if the term "light" describes some physical or organoleptic attribute of the food such as texture or color and the information, so stated, clearly conveys the nature of the product, and the attribute appears immediately proximate to the term "light" on the product's label [21 CFR 101.56(e)]. Your "Pompeian Imported Extra Light Olive Oil" product's label contains no such qualifying language associated with the term "light" and therefore does not meet the requirements to use the term "light" on its label.


Furthermore, the back panel of your "Pompeian Imported Extra Light Olive Oil" product includes the statement "high in 'good' monounsaturated fat." This statement is an unauthorized nutrient content claim. Therefore, this claim may not be used on the label or labeling of a product. Nutrient content claims for the fat, fatty acid, and cholesterol content of foods are defined in 21 CFR 101.62, which provides that claims about the level of fat, fatty acid and cholesterol in a food may only be made on the label or in the labeling of the food if the claim uses one of the terms defined in 21 CFR 101.62. However, 21 CFR 101.62 does not define "good monounsaturated fat." Accordingly, the claim about the level of "good monounsaturated fat" in your product, which appears on your product's label, does not use terms which are defined by regulation, and thus is an unauthorized nutrient content claim.


Products that bear such claims on their labels are misbranded under section 403(r)(1)(A) of the Act. Further, nutrient content claims using the term "high" are defined in 21 CFR 101.54(b),.which provides that a product may bear a "high" claim on its label only if the product contains 20 percent or more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per RACC of the nutrient to which the "high" claim refers. No RDI or DRV has been established for "good monounsaturated fat." Accordingly, the claim "high in 'good' monounsaturated fat" that appears on your product's label is not made in  accordance with the requirements of 21 CFR 101.54(b).


In addition, your product's label references your website, www.pompeian.com. Your website also bears a nutrient content claim but your product does not meet the requirements to make the claim. Specifically, your website states: "Olive oil is rich in antioxidants ...." However, your product does not meet the requirements to bear a claim that characterizes the level of antioxidant nutrients present in the product because it does not include the names of the nutrients that are the subject of the claim either: (1) as part of the claim; or (2) elsewhere on the same panel of the product label linked by a symbol to the claim, as required by 21 CFR 101.54(g)(4).

Unapproved New Drug


Based on claims made on your website, www.pompeian.com, we have determined that the product "Pompeian Imported Extra Light Olive Oil" is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Act [21 USC § 321(g)(1)]. 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 claims observed on your website include:


On a web page entitled "Healthy Living," subtitled "Benefits of Olive Oil- Heart Healthy and More":


• "Olive Oil is a major component of the Mediterranean diet, which protects the heart, may lower inflammation and coagulation, and may reduce mortality in the elderly."


• "HEART HEALTHY: Helps to lower the LDL (bad) cholesterol and to protect or raise the HDL (good cholesterol) - especially when substituted for saturated fat. Olive oil is the richest source of beneficial monounsaturated fat and is low in harmful saturated fat."


• "Protects against a variety of cancers, especially when consumed as extra virgin olive oil. Olive oil is rich in antioxidants, which have cancer fighting properties."


• "May increase insulin sensitivity in people prone to diabetes as compared to saturated fat, which increases insulin resistance."


• "Protects against thrombogenesis (blood clots) through the reduction of several plasma clotting factor levels."


Your "Pompeian Imported Extra Light Olive Oil" product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a "new drug" under section 201(p) of the 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 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.


Your "Pompeian Imported Extra Light Olive Oil" product is 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 this drug safely for its intended purposes. Thus, your "Pompeian Imported Extra Light Olive Oil" product is misbranded under section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].


The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products 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 regulatory actions without further notice, such as seizure or injunction.

You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. 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.


You should direct your written reply to Kathleen M. Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.


Sincerely,
/S/

Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition


cc: FDA Baltimore District