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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Body Systems Inc. 4/8/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
 
FLA-13-16
 
April 8, 2013
 
Mrs. Mary F. Davis-Rossi
Owner
Body Systems, Inc.
4768 Bakersfield Ct.
Winter Springs, FL 32708
 
Dear Mrs. Davis-Rossi:
 
From October 18-22, 2012, the U.S. Food and Drug Administration (FDA) inspected your facility located at 4768 Bakersfield Ct., Winter Springs, Florida.  During the inspection, you informed our investigator that your firm has entered into agreements with other manufacturers to manufacture dietary supplement products under your firm’s name. Based on our inspection and subsequent review of your product labeling, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
We received your written response dated October 26, 2012, addressing the observations cited to your firm on the Form FDA 483, Inspectional Observations, issued on October 22, 2012. We have reviewed your response, and we address your corrective actions below. Your significant violations are as follows:
 
Unapproved New Drug Violations
 
We have reviewed the labeling of your products collected at the inspection and your websites located at www.bstcatalog.com and www.bodysystemsinc.com in October 2012 and determined that your Joint-Ortho Care and Seven Flowers BP products are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates section 505(a) of the Act.
 
Examples of some of the claims observed on your website include, but are not limited to, the following:
 
Joint-Ortho Care
 
  • “…Arthritis Aid…”
  • “Over 16 million Americans suffer from…arthritis and osteoarthritis, degenerative diseases of the Teflon-like cartilage that cushion joints. JOINT-ORTHO CARE…works to repair & revitalize damaged or worn connective tissue & cartilage.”
 
Seven Flowers BP
 
  • “Seven Flowers is an anti-hypertensive Chinese herbal remedy that may nutritionally help lower blood pressure without the usual side effects of many blood pressure medications.”
 
Your products identified aboveare not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your Seven Flowers BP product is offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purpose. Thus, your Seven Flowers BP product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for this drug fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Dietary Supplement CGMP Violations
 
The October 18-22, 2012 inspection of your facility 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). These violations cause your Liquid Colloidal Minerals to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that it has been prepared, packed or held under conditions that do not meet the CGMP regulations for dietary supplements. Additionally, even if your Joint-Ortho Care were not an unapproved new drug, it would be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that it has been prepared, packed or held under conditions that do not meet the CGMP regulations for dietary supplements.   
 
During the inspection, you informed our investigator that you contract the production of your product labels with another firm and that once sent to you, you ship the labels to your contract manufacturer. You also informed our investigator that you are responsible for all content and any changes made to product labels. As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the product conforms to established specifications and whether to approve and release the product for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, 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). 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 that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and 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.
 
Our investigators observed the following CGMP violations during the inspection:
 
1.      Your firm failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, you do not have a system of production and process controls to ensure the quality of your dietary supplements that you receive from your contract manufacturers and that your dietary supplement products are labeled as specified in the master manufacturing record.
 
2.      Your firm failed to establish the following specifications related to the labeling of your dietary supplements:
 
  • Your firm failed to establish a specification or a point, step or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, and that the dietary supplement is labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a).
  • Your firm failed to establish specifications for dietary supplement labels (label specifications), as required by 21 CFR 111.70(d).
  • Your firm failed to establish specifications for the labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you applied the specified label, as required by 21 CFR 111.70(g).
 
We reviewed your response letter, dated October 26, 2012, and have determined that your response is inadequate. Your response letter does not address the absence of specifications cited in observation 1 of the FDA Form 483.
 
3.      Your firm failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). The quality control personnel must ensure that your 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). Further, you must have documentation of the quality control personnel review and approval for release, or rejection, of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and 111.140(b)(2). However, you provided no written procedures for, or documentation of, the quality control review to ensure the quality of the dietary supplements you distribute and that they are packaged and labeled according to the master manufacturing record. Moreover, your firm has failed to perform the following quality control operations related to your labeling, holding and distributing operations:
 
  • Conduct quality control operations for labels before use in the manufacture of a dietary supplement, including reviewing all received records for labels [21 CFR 111.120(a)]. You indicated that you do not examine incoming finished product labels that you receive prior to shipping them to your contract manufacturers to have the labels applied to your products.
  • Perform quality control operations for labeling operations, including reviewing and approving all records for label operations [21 CFR 111.127(c)].
  • Make and keep required quality control records in accordance with the records and recordkeeping requirements [21 CFR 111.140(a)].
 
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be inadequate. Your response did not specifically address how you will establish and identify your quality control operations. In addition, you did not provide a timeline for corrective action. The regulations require your firm to establish written procedures for the responsibilities of the quality control operations, to ensure the quality of the product you label, hold, and distribute.
 
Your response indicated you would be putting in place a written procedures manual for holding and distributing operations, for complaint operations, for packaging and labeling operations, and for returned dietary supplements. However, you did not specify any corrective action for the failure to establish written procedures for quality control. In addition, you did not provide a copy of the written procedures, or include a timeline for implementation of your corrective actions. We are therefore unable to determine the adequacy of your corrective actions.
 
4.      You firm failed to prepare and follow a master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Labeling is considered a manufacturing operation.  You must prepare an MMR that covers the labeling operations of your firm. Furthermore, you must make and keep batch production records (BPRs) in accordance with the recordkeeping requirements of 21 CFR Part 111, in accordance with 21 CFR 111.255(d).
 
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be inadequate. Your response did not address the requirement to prepare and follow an MMR for your firm’s labeling operations. Your response states that you are working with your contract manufacturers to receive a copy of an MMR one time a year and that you have “requested batch records for each shipment received and COA.” While your proposed corrective actions are important to partially satisfy the requirements of the operations conducted by your contract manufacturers, it does not satisfy the requirement that your firm create an MMR for the labeling operations of your firm.  
 
5.      Your firm failed to establish written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, your firm has not established written procedures, detailing the required operations to conduct when holding and distributing dietary supplement products, including, but not limited to the following:
 
  • Holding components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected, as required by 21 CFR 111.455(a).
  • Holding the packaging and labels under appropriate conditions so that the packaging and labels are not adversely affected, as required by 21 CFR 111.455(b).
  • Holding labels under conditions that do not lead to mix-up, contamination, or deterioration labels, as required by 21 CFR 111.455(c).
  • Holding reserve samples of dietary supplements in a manner that protects against contamination and deterioration, as required by 21 CFR 111.465(a).
  • Retaining reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations, as required by 21 CFR 111.465(b).
 
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be inadequate. Your response stated that you will be putting in place written procedures for holding and distributing operations; however, as you did not provide a copy of the written procedure, nor did you include a timeline for implementation, we are unable to determine the adequacy of your response.
 
6.      Your firm failed to establish written procedures for product complaints, as required by 21 CFR 111.553. Specifically, your firm has not established written procedures for the handling of product complaints regarding the dietary supplement products you distribute and for adequately investigating complaints and documenting the findings of an investigation and follow-up.
 
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be inadequate. Your response stated that you will be putting in place written procedures for complaint operations; however, as you did not provide a copy of the written procedure, nor did you provide a timeline for implementation, we are unable to determine the adequacy of your response.
 
7.      Your firm failed to establish written procedures for returned dietary supplements, as required by 21 CFR 111.503.
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be inadequate. Your response stated that you will be putting in place written procedures for returned dietary supplements; however, as you did not provide a copy of the written procedures, nor did you provide a timeline for implementation, we are unable to determine the adequacy of your response. 
 
Misbranding Violations
 
Your Liquid Colloidal Minerals dietary supplement product is misbranded under section 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). 
 
1.      Your Liquid Colloidal Minerals product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product by using the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term in accordance with 21 CFR 101.3(g).
 
2.      Your Liquid Colloidal Minerals product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because your label incorrectly lists dietary ingredients as “other ingredients” outside the Supplement Facts box. For example, Aloe Vera is a dietary ingredient that should be listed inside the Supplement Facts box in accordance with 21 CFR 101.36(b)(3).
 
3.      Your Liquid Colloidal Minerals product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to list all (b)(2)-dietary ingredients listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) that are contained in your product in accordance with 21 CFR 101.36(b)(2)(i). For example, you make claims on your label that your Liquid Colloidal Minerals product contains “TRACE MINERALS: Calcium, Chromium, … Selenium, Chloride, … Magnesium, Copper, Manganese, … Molybdenum, … Sodium, … Iodine, … Zinc”. These minerals shall be declared in accordance with 21 CFR 101.36(b)(2)(i) when they are added to the product for purposes of supplementation, or when a claim is made about them. Their listing on the product label is a claim about them being present in the product.
 
The violations cited in this letter are not intended to be an all-inclusive statement 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 your firm complies with all requirements of federal law 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. 
We also offer the following comments:
 
1.      Your firm includes expiration dates on the labels for your dietary supplement products. You stated to our investigator that you do not have any supporting studies and that you do not know if your contract manufacturers have such studies. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [see 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
 
2.      Your Seven Flowers BP does not bear or contain labeling as a dietary supplement, nor is the product represented for use as a conventional food. Section 201(ff)(1) of the Act[21 U.S.C. § 321(ff)(1)], in part, defines “dietary supplement” as a product “intended to supplement the diet that bears or contains [a botanical extract],” and which product “is not represented for use as a conventional food.” The list of product contents for Seven Flowers BP consists exclusively of various flower extracts, and the “suggested use” portion of the product label states, “Take 3 to 6 tablets daily when under stress. No more than 12 tables per day.” Based on this information, it appears that Seven Flowers BP is intended to be marketed as a dietary supplement. Therefore, even if Seven Flowers BP were not marketed in a manner so as to make the product a “new drug” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]:
 
  • It would be a misbranded dietary supplement within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product by using the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term in accordance with 21 CFR 101.3(g).
  • It would be a misbranded dietary supplement within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the label fails to include a “Supplement Facts” panel as required by 21 CFR 101.36. 
  • It would be an adulterated dietary supplement under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)], in that it has been prepared, packed or held under conditions that do not meet the CGMP regulations for dietary supplements.
 
The introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded and adulterated products is prohibited under section 301(a) of the Act. [21 U.S.C. § 331(a)]. 
 
Within fifteen (15) 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 cannot complete corrective action within fifteen (15) 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 cost 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 reinspection fees (21 U.S.C. § 379j31(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.
 
Please send your written reply to the Food and Drug Administration, Attention: Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
                                                                       
Sincerely,
/S/
Emma R. Singleton
Director, Florida District