From March 3, 2020, through March 18, 2020, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 4565 Kipling St., Wheatridge, Colorado. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 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 the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Additionally, our review of your product labeling that we collected during the inspection revealed that certain of your dietary supplement products are misbranded within the meaning of section 403 of the Act. You can find copies of the Act and its implementing regulations through links on FDA’s homepage at www.fda.gov.
We acknowledge receipt of your responses to the FDA-483, Inspectional Observations, dated March 27, 2020, and May 27, 2020, and we address your responses in the paragraphs below.
Adulterated Dietary Supplements
Your dietary supplements are in violation of the CGMP requirements for dietary supplements because you failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you receive packaged and labeled finished dietary supplement products at your firm for holding and distribution; however, you have not established written procedures to ensure your dietary supplements are held under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the dietary supplements are not affected (21 CFR 111.455(a)).
We have reviewed your FDA-483 responses, dated March 27, 2020, and May 27, 2020. Your March 27, 2020, response stated how holding and distributing operations are performed but did not include written procedures for our review. For example, you stated that your products are stored on shelves in your “temperature-controlled, secure lobby,” but you did not provide an SOP for storage specifying the temperature. Your May 27, 2020, response states that your “Holding and Distributing Procedures” are “in place” but provided no further supporting documentation for our review.
Misbranded Dietary Supplements
In addition, your Fos-Idophilus, Breathe Eze, D-Stress, Herbal N-Zyme, System Fresh, and Ur-NAry Fresh products are misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows:
1. Your System Fresh 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 serving size declared on the label is 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. Specifically, the directions of use for your System Fresh product suggests the consumer take 2 to 3 capsules daily but the serving size lists 2 capsules. The serving size listed should be the maximum amount of product per eating occasion.
2. Your D-Stress, Herbal N-Zyme, and Ur-N-Ary Fresh 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). For example:
- Your D-Stress product label fails to include the part of the plant from which gota kola herb and wood betany are derived.
- Your Herbal N-Zyme product label fails to include the part of the plant from which catnip gota kola, and wood betany are derived.
- Your Ur-N-Ary Fresh product label fails to include the part of the plant from which cleavers herb, cranberry extract, catnip herb, garlic, and cornsilk are derived.
3. Your Fos-Idophilus, Herbal N-Zyme, System Fresh, Breathe Eze, D-Stress, and Ur-N-Ary Fresh products are each 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 your product does not comply with 21 CFR Part 101.36. For example:
- Regarding your Fos-Idophilus product:
o It fails to declare calories in the correct increment as required by 21 CFR 101.36(b)(2)(i) and 101.9(c)(1);
o It fails to include a heavy bar beneath the last (b)(2)-dietary ingredient as required by 21 CFR 101.36(e)(6);
o It fails to include the statement “Percent Daily Values are based on a 2,000 calories diet.” as required by 21 CFR 101.36(b)(2)(iii)(D);
o It fails to declare total carbohydrate instead of total carbohydrates as required by 21 CFR 101.36(b)(2)(i) and 101.9(c)(6);
o It fails to express dietary fiber to the nearest gram and indented below total carbohydrate as required by 21 CFR 101.36(b)(2)(i) and 101.9(c)(6)(i);
o It fails to place “Daily value not established” only at the bottom of the Supplement Facts label and not collocated with a listed ingredient, as required by 21 CFR 101.36(c)(3).
- Regarding your Herbal N-Zyme product:
o It fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36(b)(3)(ii);
o It fails to place “Servings Per Container” below the serving size as required by 21 CFR 101.36(b)(ii).
In addition, your System Fresh, Breathe Eze, D-Stress, and Ur-N-Ary Fresh Supplement Facts labels declare ingredients that appear to be part of a proprietary blend, but the labels fail to indent those ingredients under the term "Proprietary Blend" as required by 21 CFR 101.36(c).
4. Your Fos-Idophilus, Breathe Eze, D-Stress, Herbal N-Zyme, System Fresh, and Ur-N-Ary Fresh products are misbranded within the meaning of section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36(d) and 21 CFR 101.4(g)-(h). For example:
- Your Breathe Eze product declares “Brigham Tea Leaf”, your D-Stress product declares “Kola Nut”, your D-Stress and Herbal N-Zyme products declare “gota kola”, your System Fresh product declares “turkey rhubarb”, and your Ur-N-Ary Fresh product declares “nettles”. These names are not standardized common names (SCN) noted in Herbs of Commerce.
- Your Fos-Idophilus product incorrectly places “Other ingredients” within the Supplement Facts label.
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 ensure your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct all 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.