Inspections, Compliance, Enforcement, and Criminal Investigations
Wendy Weihe Storlie, Inc. 12/23/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
December 23, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 12- 18
Wendy W. Storlie
Wendy Weihe Storlie, Inc.
4032 Shoreline Drive
Spring Park, Minnesota 55384-4501
Dear Ms. Storlie:
An inspection of your firm located at 4032 Shoreline Drive, Spring Park, Minnesota, was conducted by investigators from the Food and Drug Administration (FDA) and the Minnesota Department of Agriculture (MDA) on February 23 and March 11, 2011. That inspection verified that firm distributed a product intended for use as animal feed labeled as (b)(4) the (b)(4) at its facility in (b)(4) This product was adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(2)(C)(i), in that it contains deodorizer distillates, a food additive that is unsafe within the meaning of section 409 of the Act, 21 U.S.C. § 348. The product was also misbranded under section 403(i) of the Act, 21 U.S.C. § 343(i), in that the product is fabricated from two or more ingredients but its label does not bear the common or usual name of each ingredient in (b)(4) on, your firm misbranded the deodorizer distillates which you sold to (b)(4) and became an ingredient in under section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1).
Any animal food ingredient that is not generally recognized as safe (GRAS) or subject to a prior sanction requires a food additive regulation promulgated under section 409 of the Act before it may be directly or indirectly added to food (see Title 21, Code of Federal Regulations (21 CFR), section 570.30(e)). Otherwise, the substance is an unsafe food additive within the meaning of section 409 of the Act. Food is adulterated under section 402(a)(2)(C)(i) of the Act if it is or bears or contains any food a dditive that is unsafe within the meaning of section 409 of the Act. There is no food additive regulation that authorizes the use of deodorizer distillates in animal food. We are not aware of any information to indicate that deodorizer distillates are the subject of a prior sanction. Furthermore, we are not aware of any basis to conclude that deodorizer distillates are GRAS for use in animal food. (See FDA's regulation in 21 CFR 570.30 for a description of criteria for eligibility for classification of a food substance as GRAS.) Therefore, because (b)(4) contained deodorizer distillates, it was adulterated under section 402(a)(2)(C)(i) of the Act.
(b)(4) was also misbranded within the meaning of section 403(i) of the Act. Under section 403(i) of the Act, a food shall be deemed misbranded unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient. (b)(4) is a multi-ingredient food, and its label did not bear the common or usual name of each ingredient.
In addition, you misbranded the deodorizer distillates. Under section 403(a)(1) of the Act, food is misbranded if its labeling is false or misleading in any particular. Under section 201(n) of the Act, one consideration in determining whether the labeling of a product is misleading is the extent to which the labeling fails to reveal material facts. When you purchased the deodorizer distillates you subsequently sold to (b)(4) the product's labeling stated that it was not suitable for animal consumption. You did not include this material fact in the product's labeling when you sold the deodorizer distillates to (b)(4) and (b)(4) used the product in (b)(4) for use in animal feed.
We note that the inspection shows that your firm contributed to the manufacture, labeling, and marketing of (b)(4) in other ways. For example:
1. You worked with (b)(4) from (b)(4) on a sale of (b)(4) processing, which, in a February 8, 2011, email to you, he described as consisting of (b)(4)
2. You instructed (b)(4) to perform analytical testing on the final product prior to distribution as feed, selecting the testing lab, (b)(4). In an email dated February 8, 2011 from you to (b)(4)
3. In your February 8, 2011, e-mail to (b)(4) you instructed (b)(4) to (b)(4)
The introduction or delivery for introduction into interstate commerce of a food that is adulterated or misbranded, the adulteration or misbranding of any food in interstate commerce, and the receipt in interstate commerce of any food that is adulterated or misbranded and the delivery thereof for pay are prohibited acts within the meaning of section 301 of the Act, 21 U.S.C. § 331. You may find the Act and its implementing regulations through links on the internet at www.fda.gov.
On March 1, 2011, and March 11, 2011, you told an FDA investigator that in the future your firm would not sell products intended for use in animal feed from (b)(4). In your written response to this Warning Letter, please confirm your intentions with regards to products made by (b)(4) and identify the actions you will take to prevent your distribution of misbranded and adulterated animal food in the future. We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates your corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
Failure to make prompt corrections may result in enforcement action, including seizure or injunction. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with the products you market. It is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations. For example, it is your responsibility to ensure that the other ingredients in "(b)(4)" (e.g., "centrifuge dumping" and waste oil/free fatty acids) are approved food additives, subject to prior sanctions, or GRAS.
Your reply should be directed to Compliance Officer Timothy G. Philips at the address indicated in the letterhead. Mr. Philips may be reached at (612) 758-7133.
Elizabeth A. Waltrip