On August 30, September 7, and October 4, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 50744 25th Street, Mattawan, Michigan, where your firm receives, holds, and distributes dietary supplements, drugs, and cosmetics. Based on the inspection, a review of the product labeling you provided during the inspection, and our subsequent review of your website www.naturesvisioninc.com, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA's website at
www.fda.gov.
We have reviewed your written responses dated October 24, 2016, and November 30, 2016 (updated January 19, 2017), submitted in response to the FDA-483 issued to you at the close of the inspection. We include below some detailed comments regarding your response.
Unapproved New Drugs
In March, 2017, we reviewed your product labeling, including product labels and your website at the internet address http://naturesvisioninc.com, where you take orders for several of your dietary supplement products, including Cinnamon Extract tablets and Alpha Lipoic Acid tablets. Additionally, we reviewed the labels for your Elderberry Ultimate Immune Response and Party Recovery Detox Tablets.
The claims on your website for your Cinnamon Extract tablets and Alpha Lipoic Acid tablets, and the claims on your product labels for Elderberry Ultimate Immune Response and Party Recovery products establish that the 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 below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims that provide evidence that these products are intended for use as drugs include:
Alpha Lipoic Acid website claim:
* "[its] primary objective [is to] to protect cells from the oxidation which is a natural component of .... disease."
Cinnamon Extract website claim:
* "Nature's Vision customers are consistently using the product as a result of many studies and reports on the positive results for type 2 diabetes sufferers."
Elderberry Ultimate Immune Response label:
* "Suggested Use: For use by adults and children no younger than 10 years of age when symptoms of a cold appear."
Party Recovery label:
* "Suggested use***If you're in pain upon waking, take 2 or 3 tablets. If pain persists, take 2 or 3 more tablets***"
Your Cinnamon Extract tablets, Alpha Lipoic Acid tablets, Elderberry Ultimate Immune Response and Party Recovery products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are new drugs as defined in 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 and information demonstrating 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 product Cinnamon Extract is 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 product safely for their intended purposes. Accordingly, your Cinnamon Extract product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].
Dietary Supplement CGMP Violations
Even if your Cinnamon Extract tablets, Alpha Lipoic Acid tablets, Elderberry Ultimate Immune Response and Party Recovery products did not have therapeutic claims, which make them unapproved new drugs, they would still be adulterated under section 402(g)(1) of the Act, 21 U.S.C. § 342(g)(1), as are other dietary supplement products that you distribute, and that have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, 21 CFR Part III.
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements:
1. You failed to establish a system of production and process controls to 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 111.55). Specifically, you had no 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. Additionally, there were no written procedures for approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).
We note that you receive finished packaged and labeled dietary supplements from a manufacturer that manufacturers the dietary supplements on your behalf. You hold the dietary supplements in your warehouse and distribute them. You state that you tell your contract manufacturer what you want it to produce and your contract manufacturer "provides the expertise on the products." You state that you have no documentation of product specifications or certificates of analysis for the product received, and have not performed any audit or engaged in any other activity to determine the acceptability of the manufacturer to manufacturer your dietary supplement products, or to ensure the quality of the dietary supplements received and that the products are packaged and labeled as specified in the master manufacturing record.
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/or 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/or 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.
1 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)). Thus, a fmn that contracts out some or all of its operations must establish a system of production and process controls to 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 111.55). 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)].
We acknowledge receipt of your letters responding to the FDA 483, dated October 24, 2016 and November 30, 2016 (updated January 19, 2017). These letters include, copies of finished product specifications for the dietary supplements Cinnamon Extract Tablets and Garcinia Cambogia Extract Capsules. However, to the extent that you are establishing finished product specifications that your contract manufacturer must meet, these specifications do not appear to be adequate. For example:
a. Your firm's final finished product specifications for both Cinnamon Extract Tablets and Garcinia Cambogia Capsules include pesticide residue acceptance criteria of "Meets requirements." However, the specifications do not include the limits for pesticide residues, or explain where they can be found. Further, this is also contrary to section 5.3.3 of the final procedure you provided with your November 30, 2016, letter, Establishing Finished Product Specifications, which states that product specifications will include specification ranges.
b. Several tests listed in your specifications, such as disintegration, presence/concentration of the dietary ingredients, pesticide residue, and heavy metal contamination, do not specify the exact test methods that are approved by your quality department for analysis.
c. The final version of the SOP, "Establishing Finished Product Specifications," is not adequate. It includes section 5.6.6, which states, "Identification: All finished product batches will be visually examined for appearance." Appearance may not be an acceptable test for the identity of these dietary supplements. There are no other identity tests listed in the SOP.
d. The completed forms "Finished Product Specification and Batch Evaluation," for both Cinnamon Extract Tablets (lot 61971) and Garcinia Cambogia Capsules (lot 61601) are inadequate as well as incomplete. The form for the Cinnamon Extract Tablets calls for the use of
(b)(4); however,
(b)(4) was used instead, with no comment or explanation for the change. The form for Garcinia Cambogia Capsules calls the use of
(b)(4), and the form is filled out and states, "Not done."
Further, we note that your firm did not reject dietary supplements that it received from your contract manufacturer that did not meet specifications under 111.70(e). For example, your November 30, 2016 letter included copies of the document "Finished Product Specification and Batch Evaluation" for your firm's examination of Cinnamon Extract lot 61971, which shows that the batch was accepted on 11/28116. According to your letter, the batch "passed specifications" and you "did not fail the product" even though your review noted that the ingredient "
(b)(4)" was listed as an ingredient on your contract manufacturer's Certificate of Manufacturing for lot 61971. "
(b)(4)" is not listed as an ingredient either in the fmished product specification you have provided or on your finished product label that was collected during the inspection. For example, your letter includes a copy of the Certificate of Manufacturing, which lists
(b)(4) as an "inactive ingredient." Your letter also includes an undated letter from your contract manufacturer in regard to Cinnamon Extract Lot #61971 that states, "To improve the cinnamon tableting manufacturing process the ingredient
(b)(4) was added in the formulation." Your firm did not reject the dietary supplement even though it failed to meet all product specifications established in accordance with 21 CFR 111.70(e).
In addition, we received the fmal version of SOP, "Quality Control Authorities and Responsibilities," on January 19, 2017, and the final version of SOP, "Material Review and Disposition Decision (MRDD) Procedure," on November 30, 2016. Also submitted were copies of the document "Finished Product Specification and Batch Evaluation" for your firm's examination of Cinnamon Extract lot 61971, which shows that the batch was accepted on 11/28/16, even though it was noted that, according to the manufacturer's certificate of manufacturing, the product included an ingredient that is not listed in its specifications. You did not provide evidence that your firm performed a material review on this product.
Misbranded Dietary Supplements
Your Vitalsom Restorative Sleep Tablets, Party Recovery Detox Tablets, Elderberry Ultimate Immune Response, Cinnamon Extract, Garcina Cambogia, and Alpha Lipoic Acid products are misbranded under section 403 of the Act [21 U.S.C. § 343] because their labels do not comply with FDA's labeling regulations under 21 CFR Part 101, as follows:
1. Your Vitalsom Restorative Sleep Tablets, Party Recovery Detox Tablets, and Elderberry Ultimate Immune Response 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:
a. The label of each product does not segregate the 21 CFR 101.36(b)(2)- and (b)(3)-dietary ingredients into separate sections of the supplement facts label as required by 21 CFR 101.36(b)(2) and (b)(3)(i).
b. Your Vitalsom Restorative Sleep Tablets product label fails to identify the total quantity of all ingredients in the product's proprietary blend in accordance with 21 CFR 101.3 6(b)(3).
c. Your Party Recovery Detox Tablets product label declares Vitamin B3 which is not the common or usual name specified in 21 CFR 101.9 or 101.36(b)(2)(i)(B) for niacin.
2. Your Cinnamon Extract Tablets, Vitalsom Restorative Sleep Tablets, Garcinia Cambogia Extract, Party Recovery Detox Tablets, and Alpha Lipoic Acid, 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 is incorrect. The serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label, in accordance with 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example:
a. The Cinnamon Extract label's "Suggested Use" statement recommends taking up to 8 tablets at a time, but the Serving Size listed in the Supplement Facts panel is 2 Tablets.
b. The Vitalsom Restorative Sleep Tablets label's "Suggested Use" statement recommends taking up to 2 tablets at a time, but the Serving Size listed in the Supplement Facts panel is 1 Tablet.
c. The Garcina Cambogia Extract label's "Suggested Use" statement recommends taking up to 2 tablets at a time, but the Serving Size listed in the Supplement Facts panel is 1 Tablet.
d. The Party Recovery Detox Tablets label's "Suggested Use" statement recommends taking up to 3 tablets at a time, but the Serving Size listed in the Supplement Facts panel is 1 Tablet.
e. The Alpha Lipoic Acid label's "Suggested Use" statement recommends taking up to 2 tablets at a time, but the Serving Size listed in the Supplement Facts panel is 1 Tablet.
Further, as a result of the incorrect serving sizes, for each example the Servings Per Container listed in the Supplement Facts panel is also incorrect, 21 CFR 101.9(b)(8).
3. Your Cinnamon Extract, Vitalsom Restorative Sleep Tablets, Garcinia Cambogia Extract, Party Recovery Detox Tablets, and Alpha Lipoic Acid, products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include 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 supplements. "Domestic address or domestic phone number" means a complete address or phone number. The labels for these five products do not include complete addresses or phone numbers.
4. Your Vitalsom Restorative Sleep Tablets, Garcinia Cambogia Extract, and Elderberry Immune Response Oral Spray, dietary supplement products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that 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).
5. Your Vitalsom Restorative Sleep Tablets, Elderberry Immune Response Oral Spray, and Party Recovery Detox Tablets products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the labels fail to identify the products using the term "dietary supplement" in accordance with 21 CFR 101.3(g). Each of these labels includes a Supplement Facts label, which is evidence of your intent to market the products as Dietary Supplements, but the products' statements of identity do not comply with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term "dietary supplement" as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product.
The above violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all of your firm's products are in compliance with federal laws and regulations. You should take prompt action to correct the violation cited in this letter. Failure to promptly correct the violation may result in legal action without further notice including seizure or injunction.
In addition, we have the following comments:
1. We note that section 5.3 of your SOP Finished Product Evaluation states, "All finished product lots received must have a COA from the contract manufacturer, or the product cannot be received." It is unclear whether this acceptance criterion has been met, in that you have not provided certificates of analysis from your manufacturer for the Cinnamon Extract Tablets lot 61971 or the Garcina Cambogia Capsules lot 61601. The manufacturer's Certificates of Manufacturing that you provided do not appear to be certificates of analysis, in that they simply list the product name, lot number, and ingredients, and do not include analytical results for any parameter listed on the finished product specifications. We intend to verify the adequacy and implementation of your written procedures at a future inspection.
2. The completed forms "Finished Product Specification and Batch Evaluation," for both Cinnamon Extract Tablets (lot 61971) and Garcinia Cambogia Capsules (lot 61601) are inadequate as well as incomplete. For example, the form for the Cinnamon Extract Tablets calls for the use of TLC; however, HPLC was used instead, with no comment or explanation for the change. The form for Garcinia Cambogia Capsules calls the use ofTLC, and the form is filled out and says, ''Not done."
3. Your product labels The Elderberry Ultimate Immune Response product label incorrectly lists "zinc gluconate" with a Daily Value. There is no daily value for zinc gluconate. The correct nomenclature should be the name ofthe dietary ingredient, followed by the source ingredient name in parentheses, for example, zinc (zinc gluconate ). The percent Daily Value per serving should be for the quantity of zinc.
4. In regard to your "Cinnamon Extract," "Garcinia Cambogia Extract," "Party Recovery Detox Tablets," and "Alpha Lipoic Acid" product labels, please note that "Other Ingredients" (rather than the term "Inactive Ingredients") lists for dietary supplements shall be located outside the nutrition label (Supplement Facts) in accordance with 21 CFR 101.4(g).
5. As discussed above, your firm provided evidence that your contract manufacturer used the ingredient "
(b)(4)" in Cinnamon Extract Tablets lot 61971. You have not stated whether you have updated the label to include this ingredient, or provided a copy of an updated label for review. However, please be advised that "
(b)(4)" is not the common or usual name of a food ingredient.
6. Your Cinnamon Extract product label incorrectly lists "Cinnrnonum Verum" instead of Cinnamonum Verum).
7. Your Vitalsom Restorative Sleep Tablets product label declares pyridoxamine dihydrochloride and pyridoxal phosphate both of which are sources of pyridoxine (Vitamin B6). The correct nomenclature listing should be Vitamin B6 (pyridoxamine dihydrochloride and pyridoxal phosphate).
8. Your Vitasom Restorative Sleep Tablets, Party Recovery Detox Tablets, and Elderberry Ultimate Immune Response product labels fail to place a heavy bar between the (b)(2) and (b)(3) dietary ingredients. Likewise, for the Elderberry Ultimate Immune Response and Vitasom Restorative Sleep Tablets product labels, a heavy bar should be placed below the last (b)(3)-dietary ingredient.
Within 15 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 15 working days, state the reason for the delay and the time within which you will complete the corrections.
