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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CDJ Holding, Inc., DBA Pacific BioLogic Co. 4/17/14

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
FAX: (510) 337-6707

 

WARNING LETTER
 
 
April 17, 2014
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
Mr. Curtis D. Jacquot
President
CDJ Holding, Incorporated, d.b.a. Pacific BioLogic
1440 Washington Blvd. Suite A-2
Concord, California 94521
                                                                                                           
Dear Mr. Jacquot:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1440 Washington Blvd. Suite A-2, Concord, California, 94521, from March 14 through March 27, 2013. During the inspection, our investigator identified a number of significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Subsequent to the inspection, we received your June 19, 2013 response to the Form FDA 483 that our investigator issued to you.
 
In addition, during the inspection our investigator collected and reviewed samples of your labeling for many of your products. Based on this review, we have determined that your Grounded, Limbic Balance Morning Formula, Limbic Balance Evening Formula, TobacOff, and JittersAway products are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims in your labeling establish that the products are drugs 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. 
 
Even if your Grounded, Limbic Balance Morning Formula, Limbic Balance Evening Formula, TobacOff, and JittersAway products were not unapproved new drugs, your violations of 21 CFR Part 111 cause these products and your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
 
In addition, even if your Grounded, JittersAway and TobacOff products were not unapproved new drugs, as explained further below, they would be misbranded dietary supplements within the meaning of section 403 [21 U.S.C. § 343] of the Act, and its implementing regulations in 21 CFR Part 101. Furthermore, your ArteClear ® Blood Pressure, Attack 1, Attack 2, Complexion, Calm & Clear, Cough, Diabet, EstraSpecial, Female Tonic, Fortify, GI Tract: Gastro-Soothe, Prostability, GynoEase, Hair, Hepato-C, Hepato-Detox, Orthoflex, Kidney Tonic, Lower Relief, Natura-Allergy, Natura-Bronchia, Natura-Mune, Natura-Mune 2, Natura-Sinus, Qi Tonic, Self Defense, Soothing Sleep, Upper Relief, Thyrise, Toxi-Solve and ArteClear ® Circulation 2 products are misbranded within the meaning of section 403 and 21 CFR Part 101.
 
We address your June 19, 2013 response to the Form FDA 483 below.
 
You may find the Act and FDA’s implementing regulations through links at FDA’s home page at http://www.fda.gov
 
Unapproved New Drugs
 
Examples of claims in your promotional material that provide evidence that your products are intended for use as drugs include the following: 
 
Grounded
  • “[G]rounded acts to mop up … neurotoxins, correcting the subtle brain damage caused by… addictions.”
  • “What is Grounded used for?
    • Alcohol abuse recovery
    • Withdrawal from benzodiazepine abuse and dependency
    • Mood stabilizer for bipolar and unipolar disorder
    • [I]nsomnia, melancholic depression”
 
Limbic Balance Morning Formula and Limbic Balance Evening Formula
  • “What are the Limbic Balance Formulas used for?
    • Alcoholism and drug addiction
    • ADD/ADHD
    • Obsessive/compulsive disorders”
 
Under Summary of How and When to Use the Limbic Balance Formulas
  • “Limbic Balance Morning Formula … Patient self-medicates WITH:
    • Amphetamine
    • Cocaine
    • Khat (amphetamine-like drug)
    • Methamphetamines
    • Nicotine
    • Oxycodone (Oxycontin)”
  •  “Limbic Balance Evening Formula … Patient self-medicates WITH:
    • Amphetamine
    • Benzodiazepines
    • Barbiturates
    • Cannabinoids
    • Heroin
    • Methadone
    • Nicotine
    • Opiates
    • Phencyclidine (PCP)
    • Propoxyphene”
 
TobacOff
  • “The main formula to regulate tobacco craving”
 
JittersAway
  • “Most people develop nervous jittery feelings during the process of eliminating nicotine from their system. Jitters Away … eases the intensity, and shortens the duration of withdrawal.”
 
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 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Furthermore, your products Grounded, Limbic Balance Morning Formula, and Limbic Balance Evening Formula are offered for conditions that are 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 these drugs safely for their intended uses. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling 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 Violations
 
Dietary Supplements CGMP Violations
 
The inspection revealed the following violations of FDA’s CGMP regulations for dietary supplements:
 
1.    Your firm did not establish specifications for any 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 packaged and labeled as specified in the master manufacturing record (“MMR”), as required by 21 CFR 111.70(a). Specifically:
 
  • You failed to establish identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, you did not establish identity specifications for components used in the manufacture of your Grounded, Limbic Balance Morning Formula, and Limbic Balance Evening Formula products.
  • You failed to establish component specifications that are necessary to ensure that 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).
  • You failed to establish product specifications for the identity of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, the MMR for your Limbic Balance Evening Formula includes a field for “powder color,” but lacks any specification for the powder color.
 
We also note that once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73. After establishing the above specifications, you must also collect representative samples of each unique lot of packaging and labels that you use to determine whether the packaging and labels meet established specifications, as required by 21 CFR 111.80(a).
 
2.    Your firm’s batch production records (BPR) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). Specifically, your BPR for your Natura 501 product  did not include documentation, at the time of performance, of the manufacture of the batch, including the date on which each step of the MMR was performed, as required by 21 CFR 111.260(j)(1). In addition, your BPR for Natura 501 did not include a statement of the actual yield, as required by 21 CFR 111.260(f). Your batch production records must include complete information relating to the production and control of each batch, in accordance with 21 CFR 111.255(b) and 111.260.
 
3.    You failed to design your production and in-process control system to ensure that the dietary supplement is manufactured in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.60(a). Specifically, you use a method you (b)(4) to (b)(4) for (b)(4) your ingredients to produce the final blended formulas for your Grounded, Limbic Balance Morning Formula, and Limbic Balance Evening Formula products. You informed our investigator that you did not know how many times the (b)(4) was (b)(4) in (b)(4) and that you had not justified that the (b)(4) would produce a homogeneous mixture of the components in the finished product.
 
We also note that after you design your production and in-process control system to ensure that your dietary supplements are manufactured in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, you are required to establish quality control operations in accordance with 21 CFR 111.123.
 
4.    Your firm’s master manufacturing record (MMR) failed to include a description of the packaging and representative label or cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g). Specifically, your MMRs for your Grounded, Limbic Balance Morning Formula, and Limbic Balance Evening Formula products lacked this required information.
 
We have reviewed your June 19 response and determined your response to be inadequate. Your response states that “ALL Master Manufacturing records produced beginning 5/1/13, will have a representative label affixed to them.” Your response is inadequate because you failed to include appropriate documentation.
 
5.    Your firm’s MMR failed to include an accurate statement of the weight or measure of each component to be used, as required by 21 CFR 111.210(c). Specifically, for your Limbic Balance Morning Formula product, there are numerous discrepancies between the MMR and the Supplement Facts panel regarding the weight or measure of components. In particular, the MMR for that product lists 6 mg of folic acid. The Supplement Facts label for that product, however, lists 640 mcg of folic acid. The MMR also lists 4 mg of selenium, whereas the Supplement Facts panel lists 40 mcg of selenium. In addition, your MMR lists 70 mg of magnesium aspartate, whereas the Supplement Facts panel lists 14 mg of magnesium aspartate. Further, your MMR lists 4 mg of Vitamin H (Biotin), while the Supplement Facts panel lists 50 mcg of d-Biotin.
 
6.    Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you failed to conduct at least one appropriate test or examination to verify the identity of dietary ingredients used in your Grounded, Limbic Balance Morning Formula, and Limbic Balance Evening Formula. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements in 21 CFR 111.75(a)(1)(ii), and FDA has granted such petition.  Your firm has not petitioned FDA for such an exemption.
 
7.    Your firm failed to qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of the supplier’s tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, you informed our investigator that you had not qualified your suppliers by establishing the reliability of their certificates of analysis.
 
Misbranding Violations
 
1.    Your products ArteClear ® Blood Pressure, Attack 1, Attack 2, Complexion, Calm & Clear, Cough, Diabet, EstraSpecial, Female Tonic, Fortify, GI Tract: Gastro-Soothe, Prostability, GynoEase, Hair, Hepato-C, Hepato-Detox, JittersAway, Orthoflex, Kidney Tonic, Lower Relief, Natura-Allergy, Natura-Bronchia, Natura-Mune, Natura-Mune 2, Natura-Sinus, Qi Tonic, Self Defense, Soothing Sleep, TobacOff, Upper Relief, Thyrise, Toxi-Solve and ArteClear ® Circulation 2 are misbranded within the meaning of section 403(q)(1)(A) [21 U.S.C. 343(q)(1)(A)(i)] of the Act because the labels fail to declare the correct serving size, as required by 21 CFR 101.36(b) and 21 CFR 101.12(b) Table 2. The serving size is the amount of food customarily consumed per eating occasion in accordance with 21 CFR 101.9(b)(1), and the serving size must be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion” (RACCs) that appear in 101.12(b). The RACC for dietary supplements is the maximum amount recommended, as appropriate, on the label for consumption per eating occasion.
 
a.    The labels for ArteClear ® Blood Pressure, Attack 1, Attack 2, Cough, Diabet, Hepato-Detox, Kidney Tonic, Natura-Bronchia, Natura-Mune, Natura-Mune 2, Natura-Sinus, Thyrise, and Toxi-Solve have directions for use that suggest 2-4 capsules. Therefore, the serving size must be based on a RACC of 4 capsules; however, the labeling incorrectly declares the serving size as 2 capsules. 
 
b.    The labels for ArteClear ®Circulation 2, Calm & Clear, and JittersAway have directions for use that suggest 1-3 capsules. Therefore, the serving size must be based on a RACC of 3 capsules; however, the labeling incorrectly declares the serving size as 1 capsule. 
 
c.    The labels for EstraSpecial, Female Tonic, Fortify, GI Tract: Gastro-Soothe, Lower Relief, Orthoflex, Prostability, Self Defense, Upper Relief, and GynoEase have directions for use that suggest 2-3 capsules. Therefore, the serving size must be based on a RACC of 3 capsules; however, the labeling incorrectly declares the serving size as 2 capsules. 
 
2.    Your products ArteClear® Blood Pressure, ArteClear® Cholesterol, Attack 1, Attack 2, Bitter Melon, Complexion, Calm & Clear, Cognicine, Cough, Diabet, EstraSpecial, FemAbility, Female Tonic, Fortify, GI Tract: DeTox-It, GI Tract: Gastro-Soothe, GI Tract: QueasEase, Prostability, GynoEase , Hair, Hepato-C, Hepato-Detox, JittersAway, Limbic Balance Evening Formula, Limbic Balance, Morning Formula, Lower Relief, Orthoflex, Kidney Tonic, Natura-Allergy, Natura-Bronchia, Natura-Mune, Natura-Mune 2, Natura-Sinus, Qi Tonic, RMA Red Marine Algae, Self Defense, Soothing Sleep, TobacOff, Upper Relief, Thyrise, Toxi-Solve, and ArteClear® Circulation 2 are misbranded within the meaning of section 403(y) [21 U.S.C. 343(y)] of the Act because the labels fail to declare domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.
 
3.    Your product Grounded® is misbranded within the meaning of section 403(q)(5)(F) [21 U.S.C. 343(q)(5)(F)] of the Act because the label lists “other ingredients” inside the supplement facts box of the nutrition label. These ingredients should be listed outside and located immediately below the nutrition label or immediately contiguous and to the right of the nutrition label.
 
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 assure 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, but not limited to, seizure and/or injunction.
 
Within fifteen (15) working of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state 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 response should be sent to the following address: U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502. If you should have any questions regarding any issue in this letter, please contact Aleta T. Flores, Compliance Officer at 510-337-6821.
 
 
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
District Director