Inspections, Compliance, Enforcement, and Criminal Investigations

BioGenyx-Basic Reset 7/1/16

  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802

 

July 1, 2016
 
WARNING LETTER NO. 2016-NOL-10
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Fred R. Kaufman, III, Owner
BioGenyx-Basic Reset
1212 Riverchase Boulevard
Madison, Tennessee 37115
 
Dear Mr. Kaufman:
 
On March 2, 3, and 7, 2016, an investigator with the U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, located at 115 Hazel Path, Hendersonville, Tennessee.
 
In addition, FDA reviewed your product labels and websites, including: www.fredkaufman.com and www.basicreset.com in May 2016.  Based on our inspection and subsequent label and website 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.
 
Unapproved New Drugs
 
FDA reviewed your website www.basicreset.com in May 2016  and determined you take orders there for the products Ionyte, Aqualyte, Beta Factor, Bee Gold, and Primo Java.  The claims on your website establish that the Ionyte, Aqualyte, Beta Factor, Bee Gold, and Primo Java are drugs under Section 201(g)(1)(B) of the Act [21 United States Code (USC 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.[1] 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 which provide evidence that your products are intended for use as drugs include:
 
“AquaLyte***reduce, or eliminate aches and pains in joints and muscles*** prevent bone loss associated with osteoporosis***” and testimonials to relieve pain, MS symptoms, arthritis, and skin rashes”
 
“Ionyte*** eliminate aches and pains in muscles and joints*** Speeds healing of cuts, burns, bruises, insect bites/stings*** “Organo-Mineral Complexes" states in part, **IONYTE*** rheumatoid arthritis***irritable bowl [sic] syndrome***diabetes*** psoriasis *** it stops arthritis***”
 
“Beta Factor is antibacterial, antiviral, antifungal***”
 
“Bee Gold*** prevent infectious diseases such as colds and flu*** helps to reduce bad cholesterol***hereby improving the conditions that medical science connects to heart disease***”
 
“Primo Java”*** Anti-arthritic*** Anti-atherosclerotic*** Antibiotic*** Anti-calculitic *** Anti-cataract ***Antidepressant***Antidiarrheal*** Antifungal***Anti-glaucomic***Anti-Inflammatory***Anti-lipidemic*** Anti-neuralgic*** Anti-obesity***Anti-osteoporosis*** Anti-Parkinson***Anti-periodontic***Antipyretic***Anti-tumor*** Anti-vertigo***Antiviral *** Hypoglycemic***Hypotensive ***”
 
In addition, the following claims on your www.fredkaufman.com website, which was reviewed in May 2016, provide further evidence that your product is intended for use as a drug:
 
“AquaLyte:Ionic Coral Calcium Brochure*** CALCIUM DEFICIENCY: *Diabetes*Arthritis*Heart Disease* Osteoporosis*Eczema*Alzheimer’s Disease*Fibromyalgia*High Cholesterol*Muscle Cramps*Kidney Stones*Gallstones*Gout*Indigestion*Headaches*Chronic Fatigue Syndrome*Lupus*Hernia*Hypertension**Cancer***”
 
“Ionyte***Discussion on Organo Mineral Complexes (Ionyte)*** Arthritis*** Osteoarthritis*** The osteoarthiritis will stop***diabetes***psoriasis***it stops arthritis***”
 
Your AquaLyte, Ionyte, Bee Gold, Beta Factor, and Primo Java products are not generally recognized as safe and effective for the conditions prescribed, recommended, or suggested in the labeling thereof, and therefore, the products are “new drugs” under Section 201(p) of the Act [21 USC 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 USC 331(d), 355(a)]. 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 USC 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 [Title 21, Code of Federal Regulations (CFR), Part 21.5]. Prescription drugs, as defined in Section 503(b)(1)(A) of the Act [21 USC 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your AquaLyte, Ionyte, Bee Gold, and Primo Java products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.  Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, AquaLyte, Ionyte, Bee Gold, and Primo Java products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)].  The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates Section 301(a) of the Act [21 USC 331(a)].
 
Adulterated Dietary Supplements
 
Even if your AquaLyte, Ionyte, Bee Gold, and Beta Factor products were not unapproved new drugs, they would be adulterated dietary supplements based on the violations listed below.  In addition, your Body Mass Reset and all other dietary supplement products prepared, packed or held in your facility are also adulterated dietary supplements.  During the inspection, our investigator evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations and identified significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR 111.  These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Act [21 USC 342(g)(1)], because they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. 
 
1.    You failed to establish specifications which provide sufficient assurance that the product you receive from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).  The investigator found your firm has not established any specifications for the identity of the products you receive from your suppliers to ensure they are consistent with your purchase order.  You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications which ensure you used the specified packaging and/or that you applied the specified label, as required by 21 CFR 111.70(g).  The FDA investigator also found that your firm has not established any specifications for product packaging or labeling.
 
2.    You failed to establish specifications for dietary supplement labels, and for packaging that may come in contact with dietary supplements, as required by 21 CFR 111.70(d).  Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.  The investigator found your firm has not established any specifications for product packaging or labeling.
 
Once you have established packaging and labeling specifications and before you use the packaging and labeling, you must at a minimum, conduct:
  • Visual identification of the containers and closures and review the supplier’s invoice, guarantee, or certification to determine whether the packaging specifications are met [21 CFR 111.75(f)(1)]; and,
  • Visual examination of the label and review the supplier’s invoice, guarantee, or certification to determine whether label specifications are met [21 CFR 111.75(f)(2)]. 
3.    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).  Specifically, the investigator found your firm has not established written procedures for quality control and has not implemented quality control into its processes.
 
Once you have established your quality control procedure for the responsibilities of your quality control operations, you must implement the quality control operations in your packaging, labeling, and holding operations for producing the 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 111.65.
 
4.    You failed to establish and follow written procedures for complaints, as required by 21 CFR 111.553, including for the review and investigation of product complaints, as required by 21 CFR 111.560.  Additionally, your firm must make and keep a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2).
 
Specifically, you stated to the investigator that you have received complaints regarding taste, headache, and diarrhea.  However, your firm does not keep a complaint log or record of the findings of any investigation or follow up action, when such activities are performed.
 
We acknowledge your response, dated March 18, 2016, in which you stated that you established a complaint file to document each complaint.  However, we are unable to evaluate the adequacy of your response because you failed to provide documentation demonstrating that your firm has met the requirements of 21 CFR 111.553, 111.560, and 111.570.
 
5.    You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a).  Specifically, your firm applies labels to certain packaged finished products, and you repackage products such as, “Bee Gold” and “Ionyte” provided from your supplier. The investigator found you do not prepare a batch record, at the time of performance, of your labeling and/or packaging operations for your dietary supplement products [see 21 CFR 111.260(k)].
 
Your response dated March 18, 2016, states that you are in the process of getting labels printed for products which are private labeled to be sent to manufacturers to be applied to packages before they are shipped to you.  However, the response is inadequate because it did not address your obligations to prepare a batch production record for the packaging of the dietary supplement products which you package.  Furthermore, we note that although your firm may decide to contract out certain dietary supplement manufacturing operations, it cannot by the same token contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements  (see United States v. Dotterweich, 320 U.S. 277, 284 (1983) (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 which is adulterated under Section 402(g) of the Act for failure to comply with dietary supplement CGMP requirements [see 21 USC 342(g), 331(a)].  Thus, a firm which contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.  
 
As a distributor which 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 manufacturing 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)].  Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplement products into interstate commerce in their final form for distribution to consumers.  As such, your firm has an overarching and ultimate responsibility to ensure all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
 
6.    You failed to identify each unique lot within each unique shipment of received product in a manner which allows you to trace the lot to the supplier, the date received, the name of the received product, the status of the received product (e.g. quarantined, approved, or rejected), and to the product you package or label and distribute as a dietary supplement as required by 21 CFR 111.165(d)(1).  Specifically:
  • Your firm does not document or maintain lot identifying information (i.e., lot numbers) from the suppliers of your dietary supplement products in a manner which allows you to trace the lot to the supplier; and,
  • Your firm does not apply a unique identifier (i.e., lot number) to dietary supplements that you label, repackage and distribute so that it is traceable once it is distributed.
Misbranded Dietary Supplements
 
Even if your AquaLyte, Ionyte, and Bee Gold, products were not unapproved new drugs, they would be misbranded dietary supplements based on the violations listed below.  In addition, your Body Mass Reset product is also a misbranded dietary supplement.  Our review of the labels for these products identified several violations with respect to the labeling requirements for dietary supplements; therefore, these products are misbranded dietary supplements under Section 403 of the Act.  Specifically:
 
1.    Your AquaLyte, Bee Gold, Body Mass Reset, and Ionyte products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 USC 343 (s)(2)(B)] because they do not include a statement of identity as a “dietary supplement”, as required by 21 CFR 101.3(g).
 
2.    Your Ionyte and Aqualyte products are misbranded within the meaning of Section 403(i)(2) of the Act [21 USC 343(i)(2)] because the products are fabricated from two or more ingredients, and each ingredient is not declared on the labels by the common or usual name, in accordance with 21 CFR 101.4 and 101.36.  For example, the Ionyte product label declares Organic Electrolyte Complex Proprietary Complexation of Coral Minerals and the Aqualyte product label declares Coral Minerals; however, you fail to list each individual ingredient in the complex as required by 21 CFR 101.4(a) and 101.36(c)(2).
 
3.    Your Body Mass Reset product is misbranded within the meaning of Section 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 USC 343(s)(2)(A) and 343(q)(5)(F)] because the label fails to present nutrition information, including the quantitative amount by weight per serving for each dietary ingredient which is described in Section 201(ff) of the Act. For example, the Body Mass Reset product label suggests that your product is “infused with the energy of 10 herbs.”  However, you do not list these botanical ingredients and you do not list the quantitative amount by weight per serving in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(3).
 
4.    Your Bee Gold product is misbranded within the meaning of Section 403(q)(1)(B) of the Act [21 USC 343(q)(1)(B)] because the label fails to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii).
 
5.    Your Body Mass Reset, Bee Gold, and Aqualyte products are 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 products does not comply with 21 CFR 101.36.  For example:
  • The Body Mass Reset product label declares zero calories and zero calories from fat and the Bee Gold product label declares zero calories, total fat and sodium.  Any “(b)(2)”-dietary ingredients not present, or in amounts that can be declared as zero in 21 CFR 101.9(c), shall not be declared on the label.
  • The Aqualyte product label fails to declare the percent Daily Value for the “(b)(2)”-dietary ingredient, ascorbic acid.
6.    Your Bee Gold product is misbranded within the meaning of Section 403(s)(2)(A)(ii)(I) of the Act [21 USC 343 (s)(2)(A)(ii)(I)] because the label fails to include the quantitative amount by weight per serving size of all the dietary ingredients, as required by 21 CFR 101.36.  For example, the product label fails to declare the quantitative amount of the dietary ingredient, protein.
 
7.    Your Ionyte, Body Mass Reset, Bee Gold, and Aqualyte products are misbranded within the meaning of Section 403(y) of the Act [21 USC 343(y)] because the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in Section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.
 
(b)(3)
 
As a responsible official of a facility which manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
 
(b)(3)
 
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
 
(b)(3)
 
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 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, without limitation, seizure and/or injunction.
 
We offer you the following dietary supplement CGMP comment:
  • You must make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained under 21 CFR 111.14(b)(2).  Specifically, the investigator found that on the job training is provided to new employees; however, it is not documented. 
We offer you the following labeling comments:
  • Your Ionyte, Body Mass Reset and Bee Gold product labels do not include a zip code as part of the street address, as required by 21 CFR 101.5(d).
  • Your Body Mass Reset product label bears the statement “Percent Daily Values are based on a 2,000 calorie diet.”  This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
  • Your Body Mass Reset product label should list Other Ingredients (distilled water) below the Supplement Facts label as required by 21 CFR 101.4(g).
Section 743 of the Act [21 USC 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 which 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 administration expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 USC 379j-31(a)(2)(B)]. 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.
 
You are requested to notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
 
Please send your reply to Kari L. Batey, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.
 
Sincerely,
/S/ 
Ruth P. Dixon
District Director
New Orleans District

[1] As defined in 21 CFR 101.93(g)(1), a “disease” is “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” 

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