WARNING LETTER
Best Nutrition Products, Inc. MARCS-CMS 556642 —
- Recipient:
-
Recipient NameDr. Abhay K. Pati
- Best Nutrition Products, Inc.
30982 Huntwood Ave., Ste. 208
Hayward, CA 94544-7034
United States
- Issuing Office:
- San Francisco District Office
United States
| |
OHAFO West Division 5 1431 Harbor Bay Parkway Alameda, CA 94502 |
WARNING LETTER
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
September 7, 2018
WL# 556642
Dr. Abhay K. Pati, President/CEO
Best Nutrition Products, Inc.
30982 Huntwood Ave., Ste. 208
Hayward, CA 94544-7034
Dear Dr. Pati:
The United States Food and Drug Administration (FDA) inspected your facility located at 30982 Huntwood Ave., Ste. 208, Hayward, CA from April 18, 2018, through April 23, 2018. The inspection revealed serious violations of the 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 (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products 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 requirements for dietary supplements.
During the inspection, we also collected labels for your Garcinia Slim Fit & Weight Loss 75% HCA, Gymnema Sylvetre, and Shilajit Fulvic Acid products. The labeling of these products establish that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] as detailed below.
In addition, FDA reviewed your website at the internet address https://www.bestnutrition.com in June 2018 and has determined that you take orders there for your Arjuna, Bael Golden Apple, Boswellia, Boswelliac with Curcumin, Collagen, DHEA, Garlic Odorless, Glucosamine Sulfate, Gotu Kola, GTF Chronium, Guduchi, Hawthorne, Lecithin, Licorice, Tribulas, Wild Yam, and Yohimbe products. We have also reviewed your product labels and the labeling in your Ayurvedic Products Catalog and product brochures collected during this inspection. The claims on your website and other labeling establish that your Arjuna, Bael Golden Apple, Boswellia, Boswelliac with Curcumin, Collagen, DHEA, Garlic Odorless, Glucosamine Sulfate, Gotu Kola, GTF Chronium, Guduchi, Hawthorne, Lecithin, Licorice, Tribulas, Wild Yam, and Yohimbe 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.
You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
Unapproved New and Misbranded Drugs
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Bael Golden Apple
On the webpage https://www.bestnutrition.com/Bael.htm:
- “Bael has been shown to help in healing of ulcerated intestinal surfaces. Bael fruit is popularly used in diarrhea, dysentery, and has digestive and carminative properties.”
- “Helpful In . . . Diarrhea, Dysentery, Digestive and Carminative properties”
Collagen
On the webpage https://www.bestnutrition.com/Collagen.htm:
- “. . . [G]ood for joint pain, skin sore, and eye inflammations.”
Glucosamine Sulfate
On the webpage https://www.bestnutrition.com/GlucosaminSulphate.htm:
- “GS supplement can help to prevent articular joints cell degeneration, breakdown and inflammation of articular cartilages, damage to muscles and ligaments, inflamed joints and sciatic nerves and in-elasticity of inter vertebral discs.”
GTF Chromium
On the webpage https://www.bestnutrition.com/GTFChromium.htm:
- “Glucose Tolerance Factor Chromium is used for improving blood sugar control in people with prediabetes, type 1 and 2 diabetes.”
Guduchi
On the webpage https://www.bestnutrition.com/Gudiuchi.htm:
- “Guduchi Liver Tonic is used in chronic urinary tract infections as an immunomodulator and as a hepatoprotective in jaundice hepatitis and other liver problems and also in alcoholism induced hepatotoxicity.”
Hawthorne
On the webpage https://www.bestnutrition.com/Hawthorne.htm:
- “Hawthorne berries are rich in flavonoids which have been shown to dilate peripheral and coronary blood vessels. This action helps alleviate hypertension and high blood pressure and reduce the severity and frequency of angina attacks.”
Licorice
On the webpage https://www.bestnutrition.com/Licorice.htm:
- “[Licorice] is mostly used as a demulcent (soothing agent) in the digestive and urinary tracts, to help with cough and to soothe the sore throat.”
Tribulas
On the webpage https://www.bestnutrition.com/Tribulas.htm:
- “Helpful In: Poor immune system, High blood pressure, High cholesterol and Bad skin conditions including radiation and chemotherapy.”
Wild Yam
On the webpage https://www.bestnutrition.com/WildYam.htm:
- “[Wild Yam is] a great remedy for women who suffer from dysmenorrhea (painful menstrual cramps) and uterine pain.”
Other examples of some of the claims on your product labels and other labeling, including your Ayurvedic Products Catalog and your Best Nutrition Product Description brochure, that provide evidence that your products are intended for use as drugs include:
Arjuna
- “[Arjuna]may help lower systolic blood pressure levels.”
Boswellia
- “Boswellia may reduce pain and boost physical functioning in people with arthritis, asthma and inflammatory bowel diseases.”
Boswelliac with Curcumin
- “Boswelliac w/ curcumin is a potent combination of anti-inflammatory . . . properties which may be helpful in the rheumatoid arthritis.”
DHEA
- “DHEA is often taken to . . . prevent Alzheimer’s disease . . . [and] treat erectile dysfunction . . . .”
Garlic Odorless
- “The sulphur compounds [in garlic] have antibiotic and antifungal effects that help stop the liver from producing too much cholesterol and thus help prevent blood clots in the brain and heart.”
Gotu Kola
- “Gotu Kola is a rejuvenative nervine recommended for nervous disorders, including epilepsy, senility, insomnia, and premature aging.”
GTF Chromium
- “Glucose Tolerance Factor Chromium is used for improving blood sugar control in people with prediabetes, type 1 and 2 diabetes.”
Hawthorne
- “Hawthorn berries are rich in flavonoids which have been shown to dilate peripheral and coronary blood vessels. This action helps alleviate hypertension and high blood pressure and reduce the severity and frequency of angina attacks.”
Lecithin
- “The [Lecithin] supplement helps as memory aid for Alzheimer’s disease, . . . gallbladder disease, bipolar disorder, . . . and high cholesterol.”
Tribulas
- “For Urinary Infection”
Yohimbe
- “Yohimbe has been known to help alleviate symptoms of erectile dysfunction and impotence, to enhance male potency and boost performance . . . .”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, your 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 a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate 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” 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 Arjuna, Bael Golden Apple, Boswellia, DHEA, Gotu Kola, GTF Chromium, Guduchi, Hawthorne, Lecithin, Tribulas, and Yohimbe 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 safety for their intended purposes. Accordingly, your Arjuna, Bael Golden Apple, Boswellia, DHEA, Gotu Kola, GTF Chromium, Guduchi, Hawthorne, Lecithin, Tribulas, and Yohimbe 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 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)].
Dietary Supplement CGMP Violations
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products 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 which do not meet the CGMP regulations for dietary supplements. We have received your written response dated May 3, 2018, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on April 24, 2018; however, your response does not address any of the specific violations discussed below.
1. You failed to establish written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and to have qualified personnel conduct a review and investigation of product complaints, as required by 21 CFR 111.560. Specifically, you failed to establish any written procedures for product complaints, and you failed to have qualified personnel investigate the product complaints you have received. Once you have established the written procedures as required by 21 CFR 111.553, you must review and investigate product complaints, as required by 21 CFR 111.560, and make and keep a written record of every product complaint, as required by 21 CFR 111.570.
2. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have no written procedures for the holding and distribution of your dietary supplement products. Once you establish written procedures for your holding and distributing operations, we note you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
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 have no written procedures for when a returned dietary supplement is received, including procedures for identifying, holding, evaluating, and disposing of returned products. Once you have established such procedures, you must keep records of the procedures, as required by 21 CFR 111.535(b)(1).
4. You failed to establish and follow written procedures for cleaning the physical plant and grounds and for pest control, as required by 21 CFR 111.16. Specifically, you have no written procedures for cleaning the physical plant and for pest control. Once you establish the required procedures, you must make and keep records of such procedures, as required by 21 CFR 111.23(b).
Misbranded Dietary Supplements
We reviewed the labeling of your Garcinia Slim Fit & Weight Loss 75% HCA, Gymnema Sylvetre, and Shilajit Fulvic Acid dietary supplement products collected during this inspection and determined that these products are misbranded dietary supplements 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 for the reasons described below:
1. Your Gymnema Sylvestre product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label fails to declare the common or usual name of each ingredient in accordance with 21 CFR 101.4(g). Specifically, your Gymnema Sylvestre product fails to list the capsule ingredients.
In addition, your Garcinia Slim Fit & Weight Loss 75% HCA should identify the common or usual name of “HCA” in accordance with 21 CFR 101.4.
2. Your Garcinia Slim Fit & Weight Loss 75% HCA, Gymnema Sylvetre, and Shilajit Fulvic Acid products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.
We offer the following comment:
1. Your Gymnema Sylvestre product label’s principal display panel indicates “450 mg” co-located with “60 capsules”. We note the product’s nutrition information indicates that 2 capsules contain 450 mg of Gymnema sylvestre. We suggest the principal display panel be corrected to correlate with the nutrition information as this could be confusing to consumers and cause overconsumption of the product.
You should respond in writing within 15 working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. In your response, you should include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should state the reason for the delay and include a timetable for implementation of those 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 written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Refer to the Unique Identification Number CMS #556642 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla Bracy, Division Director
Office of Human and Animal Foods
Division 5 West
US Food and Drug Administration
cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435