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  5. Sportron International, Inc. - 579475 - 08/23/2019
  1. Warning Letters

WARNING LETTER

Sportron International, Inc. MARCS-CMS 579475 —


Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Drugs

Recipient:
Recipient Name
Keith J. Harding, Lynne A. Harding
Recipient Title
Owner/President, Director of Operation
Sportron International, Inc.

3900 Stonebridge Dr.
Suite 501
McKinney, TX 75070-8038
United States

Issuing Office:
Office of Human and Animal Food West Division 3

4040 N. Central Expressway
Suite 300
Dallas, TX 75204
United States


Dear Mr. and Mrs. Harding:

This is to advise you that the U.S. Food and Drug Administration conducted an inspection of your facility, located at 6040 State Highway 160, Whitewright, TX, from March 22, 2019 through March 27, 2019. Based on the inspectional findings and a review of your website at the internet address www.sportroninternational.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New Drugs/Misbranded Drugs

FDA reviewed your website at the Internet address www.sportroninternational.com in August 2019 and has determined that you take orders there for the products Sportron Omegatone, Sportron Joint Formula/A-Tron, Sportron B-Plex, and Sportron D-Plex-5000. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the website claims that provide evidence that your product(s) are intended for use as drugs include:

Sportron Omegatone

• “Reduces Inflammatory Pain”
• “Omega-3 helps blood vessels relax and eases blood flow.  Johns Hopkins School of Medicine has reviewed 17 clinical studies noting significant improvement in systolic and diastolic blood pressure.”
• “Increasing the ratio of Omega-3 to Omega-6 fatty acids may support many chronic conditions. These include cardiovascular conditions, bowel issues, joint pain, and even some brain and nervous system conditions.”
• “Other research suggests that Omega-3s are an attractive supplement for joint pain, inflammatory bowel conditions . . . Consuming NSAIDS (Non-Steroidal Anti- Inflammatory), with serious side effects, such as kidney damage and gastrointestinal bleeding, may also be reduced with the addition of Fish Oil.”

Sportron Joint Formula/A-Tron

• “Many studies confirm joint pain relief with glucosamine and chondroitin sulfate in combined use. Several large placebo controlled clinical trials demonstrated clear benefits for glucosamine treatment in joint stiffness and improvement in joint space narrowing noted on X-rays. This suggested that Glucosamine, unlike NSAIDS and other pain relievers commonly used for joint pain, may help prevent the destruction of cartilage. OsteoArthritis Research Society has recommended Chondroitin Sulfate as an effective aid for joint health.”

Sportron B-Plex

• “Anemia Support”
• “Folate, Vitamin B12, and Vitamin B6 [ingredients in Sportron B-Plex] play key roles in decreasing homocysteine, a protein product in the blood linked to hardening of the arteries. Most studies link high levels of homocysteine to increased risk of heart conditions and stroke.”

Sportron D-Plex – 5000

• “The heart muscle also has receptors for vitamin D. Studies have found that vitamin D plays a role in controlling vascular pressure and preventing damage to the artery. However, more research is needed.”
• “Multiple studies are underway regarding vitamin D’s effect on immune function. Assisting in blood sugar control and boosting our body’s defenses against respiratory infections are hot topics amongst research that is still emerging.”

The above-listed products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under Section 201(p) of the Act [21 U.S.C.§ 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in Section 505(a) of the Act [21 U.S.C § 355(a)]; see also Section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” mean directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Sportron Omegatone and Sportron B-Plex products are intended for treatment of one or more diseases that are not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, your Sportron Omegatone and Sportron B-Plex products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Adulterated Dietary Supplements

The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements under Title 21, Code of Federal Regulations, Part 111 (21 CFR 111).  These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements  Additionally, even if your Sportron Omegatone, Sportron Joint Formula/A-Tron, Sportron B-Plex, and Sportron D-Plex-5000 products did not have therapeutic claims which make them unapproved new drugs and/or misbranded drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below:

The significant violations documented during the inspection include, but are not limited to the following:

1. You failed to establish and follow written procedures for the responsibilities of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Further, you failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.140(b)(2) [see also 21 CFR 111.127(h)]. Specifically, during the inspection the investigator observed that you do not have written procedures for the responsibility of the quality control operations related to material review and disposition decisions, and you do not document how you approve and release dietary supplements for distribution [see 21 CFR 111.103 and 21 CFR 111.140(b)(2)]. 

We understand that you contract with other manufacturers to perform certain operations relating to products that are distributed into interstate commerce under your firm’s name. During the inspection, you informed the investigator that you order dietary supplement ingredients that you have shipped directly to your contract manufacturers for use in your dietary supplement products, that your firm is responsible for the labels for all of your products, and that you perform certain operations such as labeling and holding for products distributed into interstate commerce under your firm’s name. To the extent that you contract with other firms to manufacture, package, and/or 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 that 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 that 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.  See United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act).  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 that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and/or labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.

During the inspection, you were unable to provide basic information relating to the manufacture of the products you distribute.  For example, you stated that you own the formulations for your products but had no information about what the formula is.  Even if you had maintained access to such key information that you could have used to conduct a material review and make a disposition decision, you have not established the necessary written procedures for quality control.

We acknowledge your response, dated April 8, 2019, in which you state that you will follow the guidelines for reviewing documentation created by your contract manufacturers against your specification sheets for each lot during the manufacturing process and make a final disposition decision following your written procedures, which include checking the documentation you require of your contract manufacturer, such as the COA, batch record, and test record. Your response also provided a document titled “Sportron Procedure on How to Receive Product from Manufacturer Including Quality Control.”  We have determined your response to be inadequate because your procedure does not describe how you will make a disposition decision in accordance with section 21 CFR 111.113(b)(2) for when specifications are not met for a component, dietary supplement, package or label. In addition, you do not have procedures for reviewing and approving documentation for qualification of the supplier/contract manufacturer, nor is it clear how you plan to obtain access to such documentation, which you did not have at the time of the inspection. Furthermore, your plan did not clearly address the requirement that you must make and keep documentation of any material review and disposition decision in accordance with section 21 CFR 111.140(b)(3).

2. You failed to establish an identity specification for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, during the inspection, you informed our investigator that you provide (b)(4) proprietary blends – (b)(4) – that you order from a supplier and have shipped directly to your contract manufacturer for use in production of your products. However, you have no identity specification for these components. Once you have established the required specifications, you must keep records of such specifications in accordance with 21 CFR 111.95(b)(1).  You must also either ensure that such specifications are met (see 21 CFR 111.73 and 21 CFR 111.75) or conduct a material review to confirm that such specifications are met (see 21 CFR 111.103).  

3. You failed to establish component specifications that are necessary to ensure specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, during the inspection, you informed our investigator that you provide (b)(4) proprietary blends—(b)(4)—that you order from a supplier and have shipped directly to your contract manufacturer for use in production of your products. However, you have no component specifications necessary to ensure that specifications for purity, strength, and composition of dietary supplements manufactured using these components are met.  Once you have established the required specifications, you must keep records of such specifications in accordance with 21 CFR 111.95(b)(1). You must also either ensure that such specifications are met (see 21 CFR 111.73 and 21 CFR 111.75) or conduct a material review to confirm that such specifications are met (see 21 CFR 111.103).

4. You failed to establish specifications for the labeling of the finished packaged and labeled dietary supplement, including specifications that ensure that you applied the specified label, as required by 21 CFR 111.70(g). In addition, you failed to establish specifications that provide sufficient assurance that the product you receive from a supplier/contract manufacturer for packaging and labeling as a dietary supplement (and for distribution rather than for return to the supplier/contract manufacturer) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, you did not establish any labeling specifications for your dietary supplement products that you label.

We acknowledge your response, dated April 8, 2019, which states that “Sportron will create and follow bottle and/or label specifications for all dietary supplement products under our brand name.” However, we are unable to evaluate the adequacy of your corrective action because we have not seen such labeling specifications.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. 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 all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction. 

Within fifteen working days of 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 do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.  If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

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 after 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 mean 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 reply should be directed to the U.S. Food and Drug Administration; Attn: Dana Lewis, Compliance Officer, U. S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Lewis at dana.lewis@fda.hhs.gov or 214-253-5205.

Sincerely,
/S/
Edmundo Garcia, Jr.
District Director
Program Division Director
Office of Human and Animal Food West Division 3

cc:   Lori Woznicki, Food and Drug Inspection Branch Manager
        Texas Department of State Health Services
        8407 Wall Street
        Austin, TX  78754

 
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