Inspections, Compliance, Enforcement, and Criminal Investigations
Spectrum Organic Products, Inc. 2/22/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
FEB 22 2010
VIA OVERNIGHT MAIL
Neil Blomquist, CEO and President
Spectrum Organic Products, Inc.
5341 Old Redwood Hwy, Suite 400
Petaluma, California 94954
Dear Mr. Blomquist:
The Food and Drug Administration (FDA) has reviewed the label for your "Organic All Vegetable Shortening" product. 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 in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Your "Organic All Vegetable Shortening" 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 nutrient content claims but does not meet the requirements to make the claims. You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], 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)(1)(A) of the Act.
Your "Organic All Vegetable Shortening" product is misbranded because its label bears the claims "[c]holesterol free" and "naturally cholesterol free," but fails to meet the requirements to make these claims. The term "cholesterol free" may be used on the label or in the labeling of a food with a Reference Amount Customarily Consumed (RACC) of two (2) tablespoons or less that contains more than 13 g of total fat per 50 g only if the following criteria, set forth in 21 CFR 101.62(d)(1)(ii), are met: (1) the food contains less than 2 mg of cholesterol per RACC and per labeled serving; (2) the food contains no ingredient that is generally understood by consumers to contain cholesterol; (3) the food contains 2 g or less of saturated fatty acids per RACC; and (4) the label or labeling discloses the level of total fat in a serving (as declared on the label) of the food. The RACC for shortening is 1 tablespoon. Based on the nutrition information provided on your product's label, your product contains more than 13 g of total fat per 50 g of product. The nutrition information also provides that your product contains 6 g of saturated fat per 1 tablespoon. This exceeds the limit of 2 g or less of saturated fatty acids per RACC set forth in 21 CFR 101.62(d)(1)(ii). Therefore, your product does not meet the requirements for the use of the term "cholesterol free" on its label.
Your "Organic All Vegetable Shortening" product is also misbranded because its label bears the claim "[l]ess saturated fat than butter" but does not comply with the requirements for making this claim. As stated in 21 CFR 101.62(c)(4), the term "less saturated fat" may be used on the label or in the labeling of a food in a relative claim (as defined by 21 CFR 101.13(j)) if: (1) the food contains at least 25% less saturated fat per RACC than an appropriate reference food; (2) the identity of the reference food and the percent that the saturated fat differs between the two foods are declared in immediate proximity to the claim; and (3) the label includes quantitative information comparing the level of saturated fat in the product with that of the reference food. Your product label does not contain the comparative information required by 21 CFR 101.13(j)(2) [see 21 CFR 101.62(c)(4)(ii)] and therefore does not meet the requirements to bear the claim "less saturated fat than butter."
Furthermore, your "Organic All Vegetable Shortening" product is misbranded because its label bears the claim "good source of ... monounsaturated fat" but does not meet the requirements for making this claim. The term "good source," as defined in 21 CFR 101.54(c), may be used on the label or in the labeling of a food provided that the food contains 10 to 19 percent of the RDI or DRV per RACC of the nutrient to which the term refers. A DRV has not been established for monounsaturated fat. Therefore, the "good source" term cannot be used to make a claim about this nutrient.
In addition, your "Organic All Vegetable Shortening" product is misbranded because your product's label bears a nutrient content claim but fails to bear the disclosure statement required by 21 CFR 101.13(h). Your product bears the phrase "0 Grams Trans Fat" in two different locations on the principal display panel of the product label. The phrase "0 Grams Trans Fat" meets the definition of a nutrient content claim because it characterizes the product's level of trans fat, which is a nutrient of the type required to be in nutrition labeling (21 CFR 101.13(b)). The Nutrition Facts panel declares the nutrient value of 6 g satuated fat per serving (1 Tbsp). A food that bears a nutrient content claim that contains more than 4 g of saturated fat per serving must bear a disclosure statement on the label (immediately adjacent to the claim) referring the consumer to nutrition information for that nutrient, e.g., "See nutrition information for saturated fat content," as required by 21 CFR 101.13(h)(1); however, the label of your product fails to bear the required disclosure statement.
This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Your written response should be directed to Latasha Robinson, 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. If you have any questions, you may contact Ms. Robinson at 301-436-1890.
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc: San Francisco District Office