Inspections, Compliance, Enforcement, and Criminal Investigations
Modern Products, Inc. 3/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
March 7, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 – 26
Anthony A. Palermo
Chief Executive Officer
Modern Products, Inc.
6425 West Executive Drive
Mequon, Wisconsin 53092-0248
Dear Mr. Palermo:
The Food and Drug Administration (FDA) conducted an inspection of your facility at the address referenced above on August 16, 18, 29, 31, and September 6, 2011. During the inspection our investigators found that your firm is an own-label dietary supplement distributor that packages and labels dietary supplement products at your facility.
The inspection revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111), causing your Fearn Lecithin Granules, Fearn Liquid Lecithin, Fearn 100% Soy Protein Isolate, and Gayelord Hauser Brewers Yeast dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
Additionally, during the inspection we collected samples of labels for your All Natural Swiss Formula Broth and Garlic Magic! Spike Gourmet Natural Seasoning. Based on our review of your product labels, these products are misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343. Regulations implementing the food labeling requirements of the Act are found in 21 CFR Part 101.
You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Dietary Supplement CGMP Violations
Your significant violations include the following:
- You failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging or labeling and distribution as dietary supplements are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, your firm receives from three suppliers Lecithin Granules, Liquid Lecithin, Soy Protein Isolate, and Crude Inactive Yeast that your firm repackages and labels into finished products for distribution. However, your firm did not establish specifications to provide assurance that the Lecithin Granules, Liquid Lecithin, Soy Protein Isolate, and Crude Inactive Yeast were adequately identified and consistent with your purchase order, as required by 21 CFR 111.70(f).
- You failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. Specifically, you verbally confirmed to our investigator that your firm does not have records or procedures established for your dietary supplement operations.
- You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you verbally confirmed to our investigator that your firm does not have records or procedures established for your dietary supplement operations.
- You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you verbally confirmed to our investigator that your firm does not have records or procedures established for your dietary supplement operations. You must also make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b).
- You failed to package and label in a way that ensures that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.415. Specifically, you indicated to our investigator that your firm packages and labels dietary supplement products at your facility. Your firm is also an own-label distributor that labels dietary supplements with the name of your firm on the labels. However, you indicated that you were not aware of the dietary supplement regulations and did not have written master manufacturing records.
To the extent that you are an own-label dietary supplement distributor that contracts with another manufacturer to manufacture dietary supplements that your firm releases for distribution under your firm’s name, you are ultimately responsible for complying with the requirements related to manufacturing operations, even though you have hired another person to perform that job task [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)].
Your All Natural Swiss Formula Broth is misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. § 343(r)(1)(A), in that the label bears the nutrient content claims “contains…protein,” “contains…amino acids,” “plus amino acids,” and “RICH MINERAL CONTENT” but does not comply with the regulations governing the use of these claims. The claims “contains…protein,” “contains…amino acids,” “plus amino acids,” and “RICH MINERAL CONTENT” meet the definition of nutrient content claims because they characterize the level of nutrients in this product, which are nutrients of the type required to be in nutrition labeling, 21 CFR 101.13(b).
The term “contains” is defined in 21 CFR 101.54(c). This claim may be used on the label and in the labeling of foods provided that the food contains 10-19% of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per reference amount customarily consumed. However, your product does not contain at least 10% of the DRV for protein either on a serving size of one teaspoon or two teaspoons. In addition, there is no RDI or DRV established for amino acids. Therefore, the “contains…protein” and “contains…amino acids” claims on your product label do not meet the definition of “contains” in 21 CFR 101.54(c).
The nutrient content claim “rich” is defined in 21 CFR 101.54(b). This claim may be used on the label and in the labeling of foods provided that the food contains 20% or more of the RDI or DRV per reference amount customarily consumed. Calcium and iron are the two minerals declared in the nutrition label of your product. However, your product does not contain at least 20% of the RDI for calcium and iron in a serving size of one teaspoon or two teaspoons. Therefore, the “RICH MINERAL CONTENT” claim on your product label does not meet the definition of “rich” in 21 CFR 101.54(b).
The nutrient content claim “plus” is defined in 21 CFR 101.54(e). This claim may be used on the label or in labeling of foods to describe the level of protein, vitamins, minerals, dietary fiber, or potassium. Because amino acids are not included in the list of nutrients the term “plus” is authorized to describe, the “plus amino acid” claim on your product label does not meet the definition of “plus” in 21 CFR 101.54(e).
Your Swiss Formula Broth product is misbranded within the meaning of section 403(q) of the Act, 21 U.S.C. § 343(q), in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Specifically, your labeling makes the statement and claim “high potency B-Complex” and “contains…vitamin B,” but the nutrition label does not list any of the B Vitamins as required by 21 CFR 101.9(c)(8)(ii).
Further, your product fails to properly declare its serving size as specified by 21 CFR 101.9(b) and 101.12(b). The label of your product declares the serving size as “1 Teaspoon (5g).” Under the “Directions for Use,” the directions indicate a serving size of one to two teaspoons, but the nutrition label indicates a serving size of one teaspoon. The nutrition information must be based on the reference amount customarily consumed (RACC) for the serving size which is the amount of the powder that is required to make the referenced amount of the food, as required by 21 CFR 101.9(b)(9) and 101.12(c)(1). This product is represented as a “broth drink” mix. The RACC for drinks is 240ml. Therefore, the nutrition information should be based on the amount of powder which, when reconstituted, will create 240ml of liquid.
Your Salt Free Garlic Magic! Spike Gourmet Natural Seasoning product is misbranded within the meaning of section 403(i)(1) of the Act, 21 U.S.C. § 343(i)(1), because the label fails to list the common or usual name of the product. The label of your product depicts various herbs, vegetables, and fruits which imply that there is more than one ingredient in the product. However, your product is labeled only as garlic.
The above violations are not intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected. A re-inspection may be necessary.
Within 15 working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be directed to the attention of Compliance Officer Brian D. Garthwaite, Ph.D., at the address listed above. If you have any questions regarding any issue in this letter, please contact Dr. Garthwaite at (612) 758-7132.
Joann M. Givens
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