Inspections, Compliance, Enforcement, and Criminal Investigations

Carol Bond Health Foods 3/9/18

 

  

Black HHS-Blue FDA Logo

 

Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

 
 

 

March 9, 2018
 
CMS Case 541081
 
UPS Overnight
 
Daron Mettlen, Owner
Carol Bond Health Foods, Inc.
334 Main Street
Liberty, Texas 77575
 
Dear Mr. Mettlen:
 
From September 15 – 29, 2017, the U.S. Food and Drug Administration (the FDA) inspected your facility, located at 334 Main Street, Liberty, Texas. During the inspection, our investigator identified a number of serious violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements 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. 
 
In addition, we have reviewed product labels for your Carol Bond brand Dolomite, Lipo Fat Fighter, ThistleX, Injuv, and Vinpocentine products. We have also reviewed your website at www.carolbond.com in November 2017 and have determined that you take orders there for your Dolomite, Lipo Fat Fighter, ThistleX, Injuv, and Vinpocentine. The claims on your labels and 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 into interstate commerce for such use violates the Act. 
 
We have also reviewed the product labels for your CPP Natural Protein and Geri Hi dietary supplement products. Based on our review, we have concluded these products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343]. 
 
You can find the Act and the FDA regulations through links in FDA’s website at www.fda.gov.
 
Unapproved New and Misbranded Drugs
 
Examples of the claims from your product labels and website that provide evidence your products are intended for use as drugs include:
 
ThistleX
  • “ThistleX is a quadruple antioxidant . . . .[that] interfere[s] with viral proliferation.”
  • “When the liver is under attack from viruses or is weakened by hepatitis, cirrhosis, diabetes or has been abused by alcohol, drug abuse or long-term prescription drug use, the liver has [sic] shown to have low levels of these needed antioxidants found only in ThistleX. ThistleX will restore the levels of the fundamental antioxidants your liver needs to stay healthy." 
Vinpocetine
  • “Vinpocetine has been shown to be particularly effective in treating a wide variety of cerebral circulatory disorders including memory problems, acute stroke and motor disorders. Vinpocetine has been shown to be particularly effective in treating functional symptoms such as confusion, loss of attention, lack of concentration, irritability, vertigo, visual and acoustic alterations, mood changes.” 
Dolomite
  • “Dolomite is a naturally occurring form of calcium and magnesium.”
  • “Getting enough calcium is one of the best ways to prevent osteoporosis.”
  • “Magnesium . . . helps regulate blood sugar levels . . . . There is an increased interest in the role of magnesium in preventing and managing disorders such as hypertension, cardiovascular disease, and diabetes.”
  • “Main Functions: . . . Muscle cramps – it can alleviate muscle cramps and twitches”
Lipo Fat Fighter
  • “CHROMIUM PICOLINATE is a patented ingredient, scientifically tested and shown to aid in the reduction of . . . cholesterol . . . .” 
Injuv
  • “ . . . Injuv . . . provides arthritis pain relief.” 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 FDA, as described in Sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves new drugs on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
A drug 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” means 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 Dolomite, Lipo Fat Fighter, ThistleX, and Vinpocentine products are intended for treatment of one or more diseases that are not amendable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate direction for a layperson to use your products safely for their intended purposes. Accordingly, Dolomite, Lipo Fat Fighter, ThistleX, and Vinpocentine fail to bear adequate directions for their intended use 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 September 15-29, 2017, inspection of your facility revealed the following significant violations of the cGMP requirements for dietary supplements. These violations cause your dietary supplements to be adulterated under Section 402(g)(1) of 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.
 
1.    You failed to establish and follow 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 111.140(b)(1). Specifically, you have not established any written procedures for quality control operations, and you do not perform quality control functions.
 
As a distributor that 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 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 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”), and 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)]. The quality control personnel must ensure that 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). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)).
 
Once you have established your quality control written procedures, you must implement quality control operations in your holding operations, as required by 21 CFR 111.65, and you must implement a system of production and process controls to ensure the quality of the dietary supplements, as required by 21 CFR 111.55.  
 
We have reviewed your undated written response letter, received at our office on October 17, 2017; however, your response does not demonstrate that you have corrected this deficiency. Your response states that you have implemented a quality control procedure entitled “Product Standards for QC,” effective September 18, 2017. This procedure does not include specific requirements your quality control personnel must comply with to ensure all products you release into commerce are manufactured to ensure they conform to established specifications. For example, your procedure does not require quality control personnel to review documentation (such as documents provided by the manufacturer) relating to whether specifications established under 21 CFR 111.70(a) are met, as required by 21 CFR 111.105(h); nor does this procedure require you to conduct a material review and make a disposition decision if your product fails to meet specification, as required by 21 CFR 111.113(a).
 
2.    You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). Specifically, you have been distributing dietary supplements since 2013, but you have not collected and held reserve samples of the products distributed. For each lot of packaged and labeled supplements that you distribute, you must collect reserve samples and hold the samples in accordance with 21 CFR 111.83(b). Specifically, the reserve samples that you maintain must:
  • Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)].
  • Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)].
  • Be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplement associated with the reserve sample, for use in appropriate investigations [21 CFR 111.83(b)(3)].
  • Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications [21 CFR 111.83(b)(4)]. 
  • Be held in a manner that protects against contamination and deterioration, including under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions [21 CFR 111.465(a)(1)]. 
We have reviewed your undated written response letter, received at our office on October 17, 2017. However, your response does not demonstrate the sufficiency of your corrective action. While we acknowledge that you stated you have acquired a locking cabinet to hold the reserve samples you will collect for new shipments, you have not provided a procedure or explanation on how you will fulfill the requirements listed above.
 
3.    You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you did not establish written procedures for returned dietary supplements.
 
We have reviewed your undated written response letter, received at our office on October 17, 2017. However, your response does not demonstrate the sufficiency of your corrective action. Your response includes a procedure entitled “Return Policy and Procedure” for when you receive returned products. However, this procedure does not fulfill all the requirements of 21 CFR part 111, Subpart N – Returned Dietary Supplements. For example, your procedure does not require you to identify and quarantine returned supplements until quality control personnel conduct a material review and make a disposition decision, as required by 21 CFR 111.510. Your procedure also does not require you to make and keep records of any material review and disposition decision, as required by 21 CFR 111.535(b)(2), or to conduct an investigation of the manufacturing processes if the reason for the return of the supplement implicates other batches, as required by 21 CFR 111.530.
 
4.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560. Specifically, your firm has not established written procedures for reviewing and investigating product complaints. 
 
We have reviewed your undated written response letter, received at our office on October 17, 2017; however, your response is insufficient to demonstrate the sufficiency of your corrective actions. Your response included a procedure entitled “Complaints Policy” that you stated you will use for receiving complaints. However, this complaint procedure does not fulfill all the requirements of 21 CFR part 111, Subpart O – Product Complaints. Specifically, your complaint procedures do not require a qualified person to review and investigate the complaints to determine whether the dietary supplement failed to meet any of its specifications, or any other requirements of 21 CFR 111, as required by 21 CFR 111.560(a). These procedures do not require quality control personnel to review and approve decisions about whether to investigate a product complaint, and review and approve the findings and follow-up action of any investigation performed, as required by 21 CFR 111.560(b). Once you have established the appropriate complaint procedures that fulfill the requirements of Subpart O – Product Complaints, you must maintain written records of every complaint related to good manufacturing practice and records of the findings of any investigation and follow-up action when an investigation is performed, as required by 21 CFR 111.570(b)(2).
 
5.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing dietary supplement products, including, but not limited to, the requirements under 21 CFR 111.455 and 111.465. Once have you established written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
 
We have reviewed your undated written response letter, received at our office on October 17, 2017. We acknowledge that you stated you are working to establish procedures for holding and distributing operations, but as of the date of this letter you have not provided holding and distribution procedures for our review. Therefore, we are unable to evaluate the adequacy of this corrective action at this time.
 
Misbranded Dietary Supplements
 
Your Geri Hi and CPP Natural Protein products are misbranded foods under Section 403 of the Act [21 U.S.C. § 343] in that the labels for these products do not comply with the labeling requirements in 21 CFR 101. Additionally, even if your Dolomite were not an unapproved new and misbranded drug, it would be a misbranded food under Section 403 of the Act [21 U.S.C. § 343] in that the labeling for this product does not comply with the labeling requirements in 21 CFR 101. 
 
1.    Your Dolomite product is misbranded within the meaning of Section 403(r)(1)(B) of the Act [21U.S.C. § 343(r)(1)(B)] because the label includes an unauthorized health claim. Specifically, the label of the product bears the claim “Calcium helps reduce the risk of osteoporosis in some individuals.” Under Section 403(r)(1)(B) of the Act, a health claim in food labeling must be made in accordance with a regulation authorizing the use of this claim.  FDA has issued a regulation for the use of a health claim for calcium and osteoporosis (21 CFR 101.72). However, your claim fails to satisfy the specific requirements to bear the health claim. For example, under 21 CFR 101.72(c)(2)(i)(A), the claim must make clear that adequate calcium intake throughout life in a healthful diet is essential to reducing osteoporosis risk, and the claim must not imply that adequate calcium intake is the only recognized risk factor for the development of osteoporosis.
 
2.    Your Geri Hi, Dolomite, and CPP Natural Protein products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. For example, the unit of measure for iodine is incorrectly listed as milligrams. The correct unit of measure should be micrograms (mcg).
 
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products. It is your responsibility to ensure that all of your firm’s products comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above. Failure to promptly correct these violations may result in regulatory action by FDA without further notice, such as seizure and/or injunction.
 
You should respond in writing within fifteen working days of your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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.
 
Please send your written response to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328.
 
Sincerely,
/S/ 
Edmundo Garcia, Jr.
District Director
Program Division Director
Office of Human and Animal Food, WD3
 
 
 
Cc:      
Texas Department of State Health Services
Mr. Greg Wilburn
Inspection Unit Manager
Food and Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756

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