- Delivery Method:
- VIA UPS
- Dietary Supplements
Recipient NameLisa L. Harper
- Stim-O-Stam, Ltd.
179 Highway 22, Suite 200
Madisonville, LA 70447
- Issuing Office:
- Division of Human and Animal Food Operations East V
July 19, 2017
Warning Letter 523302
Dear Ms. Harper:
On March 20 and 22, 2017, investigators with the U.S. Food and Drug Administration (FDA) collected a product label from and conducted an inspection of your firm, located at 179 Highway 22, Suite 200, Madisonville, Louisiana. Based on our inspection and subsequent label review, we have identified several serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations, as discussed in detail below. You may find the Act and FDA regulations through links on FDA's Internet home page at www.fda.gov.
Adulterated Dietary Supplement
Your Stim-0-Stam® dietary supplement is adulterated under Section 402(g)(l) of the Act [21 United States Code (USC) 342(g)(1)] because it has been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). The inspection revealed the following significant violations of the CGMP requirements for dietary supplements:
1. You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, you have not established a system of production and process controls.
As a distributor which contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under Section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. 342(g) and 331 (a)]. Thus, a firm which contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105).
We acknowledge receipt of your letter responding to the FDA 483, dated April 10, 2017. The letter includes copies of your procedures 35.002 - Specifications, 35.008 - Finished Product Testing, and 35.006 Distribution of Dietary Supplements. Your Specifications procedure states that (b)(4). Your Distribution of Dietary Supplements procedure states, "(b)(4)." However, you have not provided information with which we can evaluate your production and process controls, such as copies of finished product specifications for your products' identity, purity, strength, and composition that your quality control process will evaluate.
2. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, your product complaint procedures did not specify that a qualified person review and investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specification, or any other requirement of 21 CFR 111 [see 21 CFR 111.560(a)]. Further, you did not make and keep a written procedure for the review and investigation of product complaints, as required by 21 CFR 111.570(b)(1). Our investigators were told during the inspection that your firm changed your Stim-O-Stam® finished product form from tablet to capsule due to complaints of tablets cracking; however, your firm failed to make and keep a written record of this and every product complaint related to good manufacturing practices, including the investigation to determine the root cause for the cracked tablets, as required by 21 CFR 111.570(b)(2).
We reviewed your response, dated April 10, 2017, which included a procedure entitled, "Consumer Complaints." However, your response does not provide sufficient information upon which we can evaluate the sufficiency of your corrective action. For example, the procedure states that "(b)(4)" but fails to provide information about the qualified employee, or even to specify whether the employee works for (b)(4) or for (b)(4).
Misbranded Dietary Supplement
Your Stim-O-Stam® product is misbranded within the meaning of Section 403(q)(5)(F) of the Act (21 USC 343 (q)(5)(F)) because the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. For example:
• The ingredients (b)(4), and (b)(4) are not listed on the label in accordance with 21 CFR 101.36(d). Source ingredients which supply a dietary ingredient may be identified parenthetically within the supplement facts box immediately following the name of the phosphorus dietary ingredient, or indented beneath the name of the dietary ingredient, or in the ingredient statement outside and immediately below the supplement facts box, in accordance with 21 CFR 101.4(g).
• The product label lists the quantitative amount and the %DV for potassium in the incorrect increment. The amount shall be expressed in the increments specified in 21 CFR 101.9(c)(5) and the percent of Daily Value shall be expressed to the nearest whole percent [21 CFR 101.36(b)(2)(ii)(A) and 101.36(b)(2)(iii)(C)].
• The %DV for potassium is based on the revised labeling regulation which became effective July 26, 2016, but the %DV for vitamin C and phosphorus do not follow the revised regulation. Labels must comply with the revised labeling regulation by July 26, 2018 or July 26, 2019, depending upon the annual food sales of the manufacturer. If you choose to follow the new labeling regulation at this time, you must do so consistently.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring your overall operation and the products you distribute are in compliance with the law.
We request the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, (b)(3)(A).
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, (b)(3)(A). This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the Agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to 301-210-0247 or mailed to the address above. (b)(3)(A).
This letter is not intended to be an all-inclusive list of violations in connection with your products or 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 your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
We also have the following comments:
• We note that your procedures provided with your April 10, 2017, letter require retention of procedures for two years past the date of obsolescence, and in some procedures, the retention of quality records for specified timeframes beyond the date of expiration of the product. However, your products are not currently labeled with expiration dates. Additionally, please be advised 21 CFR 111.605(a) requires written records required by the rule shall be kept for one year past the shelf life date, if shelf life dating is used, or two years beyond the date of distribution of the last batch of dietary supplements associated with the records.
• Your Stim-O-Stam® product label bears the following statement: "Percent values are based on 2,000 calories diet." The label should only bear this statement when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein [21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)].
• The serving size multiplied by the number of servings per container does not equal the net contents on the label.
• Although there is no requirement for a website address on the label of a dietary supplement, we note the website listed on your Stim-O-Stam® product label, www.stim-o-stam.com, is not functional.
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such corrective actions. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Kari L. Batey, Compliance Officer, 404 BNA Drive, Suite 500, Nashville, Tennessee 37217. If you have questions, please contact Ms. Batey via 615-366-7808.
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations-East
Lucas W. Ramirez, Manager
179 Highway 22, Suite 200
Madisonville, LA 70447