From February 24, 28, and 29 and March 1, 3, and 6, 2017, the U.S. Food and Drug Administration (FDA) inspected your facility located at 3149 Midland Drive, Ogden, Utah. During the inspection, our investigator found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements to be adulterated under 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 insanitary conditions that do not meet cGMP regulations for dietary supplements.
In addition, we have reviewed your website at the Internet address at http://www.inno-vita.com/index.htm and your product labeling. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA's website at
www.fda.gov.
Unapproved New Drugs and Misbranded Drug Violations
The FDA reviewed your website at the Internet address http://www.inno-vita.com/index.htm in August 2017, and has determined that you take orders there for your Phung-Ex, Micro-Site, Kardi-Air, Pro-Prosta, Xpleen, Immunis, and Bacto-Ex capsule products. In addition, we have reviewed your product labels for Phung-Ex, Immunis, Hysta-Min, and Bacto-Ex capsule products collected during the February 2017 inspection. The claims on your website and product labeling establish that these 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.
Examples of some of the claims on your website and your product labeling that provide evidence that your products are intended for use as drugs include:
Phung-Ex
* "Remove Spore Organism ... "
* "Phung-Ex helps the body rid itself of harmful mold, yeast and fungus, and eliminates unfriendly microorganisms in the digestive tract. .. "
* "Helps body to end the proliferation of dangerous fungus and end its toxic by-products ... "
* "Helps body's own ability to effectively remove haimful funguses .... "
Micro-Site
* "Remove Circulatory Parasites ... "
* "Micro-Site is a parasiticide compound of medicinal herbs and ingredients that help the body remove circulatory parasites (micro and cellular sized) and their toxic byproducts ... "
Para-Mac
* "Remove Gastrointestinal Parasites ... "
* "Para-Mac is an effectively blended parasiticide to help the body remove gastrointestinal parasites and their toxic byproducts ... "
Kardi-Air
* "[B]eneficial for depression ... erectile dysfunction ... "
Pro-Prosta
* "Helps body's own ability to remove foreign materials from the prostate ... "
Xpleen
* "[R]emove foreign materials from the blood ... "
Immunis
* "[H]elps body respond punctually to cellular level infectants ... "
Hysta-Min
* "[C]ontributes to the body's natural ability to respond to environmental allergens and reduce negative influences of the inflammatory response ... "
Bacto-Ex capsules
* "Bacto-Ex ... Remove Single Cell Microorganism ... "
* "[H]elps the body shield and fight again harmful microorganisms ... "
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 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 infonnation 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 CPR 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 Kati-Air product is intended for treatment of one or more diseases that are not amenable to self diagnosis or treatment without the supervision a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, KariAir 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
In addition, our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CMGP) regulations for dietary supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CPR Part 111). These violations cause 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 they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
During the inspection, investigators observed the following significant violations:
1. You failed to establish specifications for the identity of components that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, in your response dated March 22, 2017, you provided an, "Inno-Vita Raw Ingredient Specification Sheet," for each dietary ingredient. On these specifications sheets, you document establishing organoleptic identity specifications for all components. Organoleptic analysis may not be an appropriate method of testing for certain substances. This is particularly true when the nature of the substance decreases the reliability of organoleptic analysis. For example, while organoleptic analysis may be an appropriate identity test for whole or coarsely-cut botanical parts, it may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur [Federal Register, Vol. 72, No. 121, June 25, 2007, p. 34852]. All of the dietary ingredients that you use to manufacture your dietary supplements are in bulk powdered or liquid fmm. Once you have established appropriate component identity specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21CFR111.75(a)(1)(i), unless you petition the agency under 21 CPR 111.75(a)(1)(ii) and the agency exempts you from such testing.
In your response dated June 15, 2017, you provided
(b)(4) test results for identity testing of three components and you further state that "positive coffelation exists between reference and sample". Revised component specifications, incorporating
(b)(4) as an identity specification, have not been provided. Therefore, we cannot evaluate the adequacy of your corrective action.
2. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, for each dietary supplement that you manufacture, as required by 21 CPR 111.70(e). Specifically, in your response dated March 22, 2017, you provided an "Irmo-Vita Product Specification Sheet" for each of your finished products, and all finished products have organoleptic identity specifications. Organoleptic identity specifications may not be appropriate for all of these finished products. [Federal Register, Vol. 72, No. 121, June 25, 2007, p. 34852]. Organoleptic analysis may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur. Examples of some of your finished products that lack adequate identity specifications are Hysta-Min, Man-Affirm, Phung-EX, and Bacto- EX. In addition, you have not established finished product specifications for purity, strength, and composition. Once you have established these finished product specifications, you must verify that your finished batch of the dietary supplement meets product specifications, as required by 21 CPR 111.75(c). Your June 15, 2017, response did not provide any further evidence or documentation of coffective actions regarding finished product specifications.
3. You failed to establish written procedures to fulfill the requirements for returned dietary supplements, as required by 21 CPR 111.503. In your response, dated March 22, 2017, you provided new Standard Operating Procedure (SOP)#: 17-02180, Product Returns, Version# 1, with a date of implementation listed as February 28, 2017. Specifically, this SOP is inadequate in that it does not have procedures on conducting an investigation of the manufacturing process if the reason for the returned supplements implicates other batches in accordance with 21 CPR 111.530. Your June 15, 2017, response did not provide any further evidence or documentation of coffective actions regarding returned dietary supplements.
4. You failed to establish written procedures to fulfill the requirements related to product complaints, as required by 21 CPR 111.553. In your response dated March 22, 2017, you provided Standard Operating Procedure (SOP)#: 17-0306, Procedure for Product Complaints, Version# 1, with a date of implementation listed as 03/06/17. Specifically, this SOP is inadequate in that it does not have procedures to ensure that the review and investigation of a product complaint be extended to all relevant batches. The review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and follow-up action of any investigation performed, must extend to all relevant batches and records in accordance with 21 CPR 111.560(c). Your June 15, 2017 response did not provide any further evidence or documentation of coffective actions regarding the requirements for product complaints.
Dietary Supplement Labeling Violations
Even if your product labeling and website did not contain claims that cause some of your products to be unapproved new and misbranded drugs, they would still be misbranded foods 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 CPR 101, as follows:
1. Your Bacto-Ex Herbal Liquid Compound product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size.
In addition, your Immunis product label is 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 label is incorrect. The common household measure must be followed by the equivalent metric quantity in parentheses.
2. Your Bacto-Ex Herbal Liquid Compound product is misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the label fails to declare the servings per container in accordance with 21 CPR 101.36(b)(1)(ii).
3. Your Bacto-Ex Herbal Liquid Compound product is 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 does not comply with 21 CPR 101.36.
4. Your Bacto-Ex capsules, Hysta-Min, Immunis, Man-Affam, Bacto-Ex Herbal Liquid Compound, and Phung-Ex dietary supplement products are misbranded within the meaning of sections 403(q)(5)(F) and 403(i)(2) of the Act [21 U.S.C. §§ 343(q)(5)(F) and 343(i)(2)] in that they are fabricated from two or more ingredients, but the labels fail to declare the common or usual names of each ingredient used as required by 21 CPR 101.36 and 21 CPR 101.4. For example:
* Bacto-Ex capsules lists "Spleen and Thymus F01mCode," Hysta-Min, Bacto-Ex Herbal Liquid Compound, and Immunis list "Thymus FormCode," Man-Affirm lists "Prostate FormCode," and Phung-Ex lists "Thymus and Pancreas F01mCode" as dietary ingredients. "Spleen and Thymus Form Code," "Thymus Fo1mCode," "Prostate F01mCode," and "Thymus and Pancreas FormCode" are not the common or usual name of an ingredient as required by 21 CPR 101.36 and 21 CPR 101.4(h). The names of these ingredients and information stated on your website, www.inno-vita.com, regarding FormCode ingredients imply the FormCode ingredients declared consist of sub-ingredients.
According to 21 CPR 101.4(b)(2), the requirement to list component ingredients (or "subingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
* Ethyl alcohol and the distilled spirit
(b)(4) are stated as ingredients in the Bacto-Ex Herbal Liquid Compound product manufacturing documents collected during the inspection but these ingredients are not declared on the product's label in accordance with 21 CFR 101.4(g).
* Your Bacto-Ex Herbal Liquid Compound and Immunis product labels declare artesian spring water as a dietary ingredient. Atiesian spring water must be declared in a separate ingredients list on the product's label in accordance with 21 CFR 101.4(g).
* Your Bacto-Ex, Man-Affitm, Phung-Ex, and Hysta-Min product labels declare the ingredient "Polysaccharide" but fail to list the name of the individual Polysaccharide.
5. Your Bacto-Ex (capsules and herbal liquid compound), Hysta-Min, and Immunis products are misbranded within the meaning of sections 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 U.S.C. §343(s)(2)(A) and 343(q)(5)(F)] in that the labels fail to list the name of each dietary ingredient of the supplement that is described in section 201(ff) and the quantitative amount by weight per serving for each dietary ingredient. For example, your Bacto-Ex, Hysta-Min, and Immunis labels contain ingredient information to suggest that your products contain 21 CFR 101.4(b)(2)-dietary ingredients. You do not list these dietary ingredients and you do not list the quantitative amount by weight per serving in the Supplement Facts label in accordance with 21 CFR 101.36(b)(2) and 101.36(c)(1). In addition, your Immunis and Bacto-Ex Herbal Liquid Compound products are also futiher misbranded within the meaning of section 403(s)(2)(A)(ii) of the Act [21 U.S.C. § 343(s)(2)(A)(ii)] in that the products' labels fail to include the quantitative amount by weight per serving size of each dietary ingredient or the total quantity of all ingredients in a proprietary blend as required by 21 CFR 101.36(c).
6. Your Immunis product is misbranded within the meaning of section 403(r)(6)(C) of the Act [21 U.S.C. §343(r)(6)(C)] because the label makes strncture function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(c).
7. Your Bacto-Ex Herbal Liquid Compound product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label does not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g).
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter and prevent their further recurrence.
Failure to promptly correct the violations specified above may result in enforcement action without futiher notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
In addition to the above violations, we have the following comments:
1. Your Bacto-Ex capsules product lists "Burdock (Arctium loppa)" as a dietary ingredient. If your intent was to list Arctium lappa, the word "lappa" is misspelled. Your Man-Affirm, Hysta-Min, and Phung-Ex products list "Rice Flower" as an ingredient. If your intent was to list rice flour, the word flour is misspelled.
Additionally, due to the alcohol content of your liquid products, you should submit the formulas for all of your liquid supplements to the Alcohol and Tobacco Tax and Trade Bureau (TTB) on their form 5154.1, Formula and Process for Nonbeverage Product, along with a 4oz. sample of each for analysis. Electronic copies of forms and additional information can be viewed on the TTB website at www.ttb.gov. Copies of any submissions made to TTB and any return correspondence should be maintained on file at your firm.
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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspectionrelated costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection 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 re-inspection-related costs from the responsible paiiy for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Include an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections.
