WARNING LETTER
Nature’s Supplements, Inc.
MARCS-CMS 604686 —
July 13, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
Recipient Name
Arturo Costilla
Recipient Title
Co-Owner/President
Nature’s Supplements, Inc.
1342 Rocky Point Dr.
Oceanside
,
CA
92056-5864
United States
Issuing Office:
Office of Regulatory Affairs
United States
WARNING LETTER
WL 604686
Dear Mr. Costilla:
The United States Food and Drug Administration (FDA) inspected your facility located at 1342 Rocky Point Dr., Oceanside, CA on January 13, 15-16, and 22-23, 2020. 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 the dietary supplement products manufactured at your facility 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 several of your BioLife Nature’s Supplements brand products. A subsequent review of 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.
You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
We have received your written response dated February 19, 2020, concerning the Form FDA 483, Inspectional Observations, which was issued to you on January 23, 2020.We address your response below in regard to the specific violations.
Adulterated Dietary Supplements
Our inspection of your facility revealed the following significant violations of CGMP requirements for dietary supplements:
1. You failed to establish finished product specifications for each dietary supplement for the identity, purity, strength, and composition for the finished batch of the dietary supplement that you manufacture to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you failed to establish finished product specifications for the following products:
a) MRM Nutrition brand Neuro-Max II Nootropic.
b) Dr. Beckers BioNutrients brand Glucomannan Fiber.
c) BioLife Nature's Supplements brand Vitami-Life.
d) BioLife Nature's Supplements brand Biotropic.
e) BioLife Nature's Supplements brand Desintoxicador #3.
In your response received on February 19, 2020, you asserted that your method to ensure purity includes
(b)(4)
product testing for certain contaminants and a new contaminant detection system, that your specifications for strength will include locating a qualified person to analyze your raw materials using a
(b)(4)
system, and that your specifications for identity include a new process to analyze the
(b)(4)
from the production records. You also provided “
(b)(4)
” for the Neuro-Max II Nootropic and Biotropic products, which you assert help demonstrate your corrective actions. However, while your response correctly identifies certain contaminants of concern, the act of testing for the presence of such contaminants, or of analyzing raw materials or finished products, is not a specification. Specifications establish criteria such as the minimum or maximum quantity of a substance, or the absence of a particular contaminant, to ensure the quality of the dietary supplement. A possible specification would be, for example, no more than
(b)(4)
of a particular potential contaminant. Moreover, the testing that you purport to use for purity does not actually test for purity. Rather, the testing you describe relating to “purity” is actually for limits of contamination. Your testing for strength may be adequate once you have hired a qualified analyst to operate the
(b)(4)
but testing is not a specification. Your response also does not explain what you mean by "
(b)(4)
" or how it would provide information on product identity, so we are unable to evaluate this part of your proposed correction relating to product identity.
2. You failed to have quality control operations determine whether all labels conform to specifications established under 21 CFR 111.70(d), as required by 21 CFR 111.120(b). Specifically, your product labels for the following products do not conform with the specifications as established in the relevant MMRs:
a) For your BioLife Nature's Supplements brand Vitami-Life and BioLife Nature's Supplements brand BioMultivitamins, the MMR includes the following components that are not listed on the product label: Vitamin A 250,000 IU, Vitamin K2 MK7 1% on DCP, Boron Citrate, Zinc Citrate 32%, Copper Sulfate, Selenium, 72 Trace Mineral, Coral Calcium, Manganese Chelate 20%, Iodine (from Kelp), Chromium Polynicotinate, Molybdenum Chelate 0.2%, Vanadyl Sulfate, and Potassium Phosphate.
b) For your BioLife Nature's Supplements brand Biotropic, the MMR includes following the components that are not listed on the product label: Red 40 FD&C, aloe vera, and Moringa.
In your response received February 19, 2020, you acknowledged that your
(b)(4)
did not conduct a material review and make a disposition decision but stated
(b)(4)
training was ongoing to ensure that each
(b)(4)
is familiarized with all SOPs and procedures. However, you did not include documentation of the revised MMR and labels in your response or otherwise provide training records for your
(b)(4)
or other records to demonstrate your corrective actions.
3. Your MMRs failed to include all information as required by 21 CFR 111.210. Specifically, your MMRs for products MRM Nutrition brand Neuro-Max II Nootropic and BioLife Nature's Supplements brand Vitami-Life, Desintoxicador #3, and Biotropic failed to include a representative label or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g).
In your response received on February 19, 2020, you provided copies of the MMRs for the products Neuro-Max II Nootropic and Biotropic; however, the MMRs do not include a representative label or a cross-reference to the physical location of the actual or representative label. Additionally, you did not provide revised MMRs for the products Vitami-Life and Desintoxicador #3.
4. You failed to establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.303. For example, you did not have written procedures for the following laboratory operations used to determine whether one or more specifications for your Neuro-Max II Nootropic, Glucomannan Fiber, Vitami-Life, Biotropic, and Desintoxicador #3 are met:
a) Use of your
(b)(4)
spectroscopy (
(b)(4)
).
b) Use of your
(b)(4)
instrument.
c) Use of your
(b)(4)
machine.
d) Creating qualified reference standards for the
(b)(4)
testing performed.
We have reviewed your response dated February 19, 2020, in which you stated
(b)(4)
. Because no laboratory procedures were provided, we are unable to evaluate the adequacy of your corrective actions.
Misbranded Dietary Supplements
We reviewed the labeling of your for BioLife Nature’s Supplements brand 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 BioLife Nature’s Supplements brand Vitamin-Life, Bio Multivitamins, Detoxifier 3, Desintoxicador #3, and Tropic-Aid 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 nutritional information on the labeling of the products do not comply with 21 CFR Part 101.36. For example:
a) For the Vitamin-Life and Desintoxicador #3 products, the labels fail to include the Supplement Facts heading, while for the Bio Multivitamins and Detoxifier 3 products, the heading is incorrectly identified as “Nutrition Facts,” as required by 21 CFR 101.36(e)(1).
b) For the Vitamin-Life and Tropic-Aid products the nutrients are not listed in the order required by 21 CFR 101.9(c)(8)(v) and 21 CFR 101.36(b)(2)(i)(B).
c) For the Bio Multivitamins product, the proprietary blend incorrectly declares (b)(2)-dietary ingredients with (b)(3)-dietary ingredients. The declaration of (b(2)-dietary ingredients must be in accordance with 21 CFR 101.36(c)(1) and 101.36(b)(2)(i).
d) For the Vitami-Life and Bio Multivitamins products, the declared (b)(2)-dietary ingredient names are not in accordance with 21 CFR 101.36(b)(2)(i) and 101.9(c)(8)(iv)-(v).
e) For the Vitami-Life and Bio Multivitamins products, the source ingredient for each (b)(2)-dietary ingredient fails to be declared in accordance with 21 CFR 101.36(d).
f) For the Vitamin-Life and Desintoxicador #3 products, the labels fail to include the subheading “Serving Size” placed under the heading of and aligned on the left side of the nutrition label, as required by 21 CFR 101.36(b)(1)(i).
g) For the Vitamin-Life, Detoxifier 3, and Desintoxicador #3 products, the labels fail to include:
i. The heading of “% Daily Value,” as required by 21 CFR 101.36(b)(2)(iii)(A),”
ii. The percent Daily Value of each (b)(2)-dietary ingredient, as required by 21 CFR 101.36(b)(2)(iii)(B), based on the serving size, or
iii. A symbol placed in the “Percent Daily Value” column that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement “Daily Value not established,” as required by 21 CFR 101.36(b)(2)(iii)(A), (B), or (F).
h) For the Bio Multivitamins product, the “% Daily Value” header is incorrectly identified as the “% USRDA*” and fails to list the percent or symbol required by 21 CFR 101.36(b)(2)(iii)(A) or (F).
i) For the Bio Tropic and Tropic-Aid products, the Supplement Facts labels include nutrients which are or can be expressed as zero. Such nutrients may not be declared in accordance with 21 CFR 101.36(b)(2)(i).
j) For the Bio Tropic product, the Supplement Facts label is not listed on the information panel which is immediately contiguous to and to the right of the principal display panel as required by 21 CFR 101.2(b).
k) For the Bio Tropic and Tropic-Aid product, the Calories declaration is not listed first in the column of names, beneath a light bar separating the heading "Amount Per Serving" from the list of names, as required by 21 CFR 101.36(b)(2)(i)(B)(1). In addition, the quantitative amount per serving is not expressed to the nearest 5-calorie increment as required by 21 CFR 101.9(c)(1).
l) For the Tropic-Aid and Bio Tropic products, the % DV for the total carbohydrate and sodium is incorrect. For the Tropic-Aid product, the % DV for the dietary fiber is incorrect. For the Bio Tropic product, the unit of measure for fiber is incorrect and we suggest the % DV be reevaluated and calculated in accordance with 21 CFR 101.36(b)(2)(iii)(B).
m) For the Vitami-Life, Bio Multivitamins, Detoxifier 3, and Tropic-Aid products, the other ingredients list fails to be placed immediately below the Supplement Facts label as required by 21 CFR 101.4(g).
n) For the Tropic-Aid and Bio Tropic products, each label fails to correctly declare the quantitative amount of the proprietary blend in accordance with 21 CFR 101.36(b)(3)(ii)(A). The quantitative amount by weight per serving must be expressed using metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,100 mg must be expressed as 1.1 g)
o) For the Desintoxicador #3 product, the statement “Percent Daily Values are based on a 2,000 diet” 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).
p) For the Tropic-Aid product, “Values not established” is not in accordance with 21 CFR 101.36(c)(3).
2. Your BioLife Nature’s Supplements brand Vitami-Life, Bio Multivitamin, Detoxifier 3, Desintoxicador #3, Bio Tropic, and Tropic-Aid products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
3. Your BioLife Nature’s Supplements brand Vitami-Life and Desintoxicador #3 products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that their labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
4. Your BioLife Nature’s Supplements brand Vitami-Life, Bio Multivitamins, Detoxifier 3, Desintoxicador #3, and Tropic-Aid products are misbranded within the meaning of Section 403(q)(1)(B) because the labels fail to list the servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii).
Specifically,
a. The Vitami-Life and Tropic-Aid labels fail to list the servings per container.
b. For the Bio Multivitamins and Detoxifier 3 products, the servings per container is incorrect. The serving size is listed as 2 capsules and the net quantity of contents for the container is 60 capsules. Therefore, the servings per container should be 30, not 60.
5. Your BioLife Nature’s Supplements brand Detoxifier 3, Bio Tropic, and Tropic-Aid products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
6. Your BioLife Nature’s Supplements brand Bio Tropic and Tropic-Aid products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2.
a. Your Bio Tropic product’s serving size is shown as “
(b)(4)
” but your Suggested Use is “
(b)(4)
” Therefore, the serving size should be 2 fluid ounces.
b. Your Tropic-Aid product’s serving size is shown as “
(b)(4)
” but your Suggested Use is “
(b)(4)
” Therefore, the serving size should be 3 fluid ounces.
7. Your BioLife Nature’s Supplements brand Bio Tropic and Tropic-Aid product labels are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.§ 1453(a)(2) of the Fair Packaging and Labeling Act. The labels declare the net quantity of contents as 32 FL. Oz., but fail to include the metric equivalent.
8. Your BioLife Nature’s Supplements brand Vitami-Life, Desintoxicador #3, and Bio Multivitamins products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. Terms such as PABA and Bio Mineral are not common or usual names of an ingredient. Furthermore, although you provided a revised Desintoxicador #3 label, the ingredients that make up the capsule are not declared.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or 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, including 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 regarding the labeling of your products:
Your BioLife Nature’s Supplements brand Vitami-Life, Bio Multivitamins, Detoxifier 3, Bio Tropic, and Tropic-Aid products labels contain the FDA disclaimer statement. However, this disclaimer is not linked to any specific structure function claim on the product label. The FDA disclaimer statement as noted on your product label must be bolded and set off in a box, and the symbol preceding the disclaimer statement must be linked to the same symbol placed at the end of each structure function statement on the label in accordance with 21 CFR 101.93(d) and (e).
Your BioLife Nature’s Supplements brand Tropic-Aid and Bio Tropic products fail to identify the function of chemical preservatives listed in the other ingredients statement (potassium sorbate) per 21 CFR 101.22(j).
Within fifteen 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 working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
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
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Refer to the Unique Identification Number CMS 604686 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 R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations-West Division 5
Content current as of:
07/13/2020
Regulated Product(s)
Dietary Supplements