- Herbal Junction
- Issuing Office:
- Seattle District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
In reply refer to Warning Letter SEA 16-09
Jerry L. Smith, Owner
PO Box 50041
Dear Mr. Smith:
The United States Food and Drug Administration (FDA) inspected your processing facility, located at 50 East 25th Avenue, Eugene, Oregon, from May 26 - 29, 2015, and June 4, 2015. At this facility, you manufacture herbal enzyme elixirs that you market as dietary supplements. The liquid concentrates, coolers, herbal infusions, power tonics, tinctures and bars manufactured at this facility are marketed as conventional foods.
During the inspection, we evaluated your dietary supplement manufacturing, packaging, labeling and holding operations for compliance with Title 21, Code of Federal Regulations (21 CFR), Part 111. Your dietary supplement products comprise: Herbal Enzyme Elixir Cosmic Think Drink Herbal Supplement, Herbal Enzyme Elixir Exotic Dream Herbal Supplement, Herbal Enzyme Elixir Liver Tea and Justice Herbal Supplement, Herbal Enzyme Elixir Flower Power Herbal Supplement, Herbal Enzyme Elixir Ginger Alchemy Herbal Supplement, Herbal Enzyme Elixir Mate Way Herbal Supplement, Herbal Enzyme Elixir Love Potion #9 Herbal Supplement, Herbal Enzyme Elixir Amazon Nectar Herbal Supplement, Herbal Enzyme Elixir Around the World Herbal Supplement, Herbal Enzyme Elixir Scarlet Ambrosia Herbal Supplement, and Herbal Enzyme Elixir Velvet Vision Herbal Supplement. The inspection revealed significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations (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 the CGMP regulations for dietary supplements.
During the inspection, we also collected a sample of your Sky High Chai Organic Liquid Concentrate product. Based on your firm’s practice of shipping this hermetically-sealed product in unrefrigerated conditions, combined with FDA sample results indicating product pH above 4.6 and water activity above 0.85, your Sky High Chai Organic Liquid Concentrate is a low-acid food product, as defined by 21 CFR 113.3(n). The inspection revealed serious violations of the low-acid foods regulation (21 CFR Parts 108 and 113). These violations cause your low-acid food product to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
Additionally, based on our review of product labels collected during the inspection, several of your products are misbranded under section 403 of the Act [21 U.S.C. § 343], as explained further below.
We received two e-mails from you on June 18, 2015, and June 19, 2015, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm. We requested you submit a written response, and we subsequently received your written response to the FDA 483 on July 7, 2015. We address your response received July 7, 2015, below, in relation to the adulterated dietary supplements and adulterated low-acid food violations.
Adulterated Dietary Supplements
Our inspection revealed the following violations of the dietary supplement CGMP requirements:
1. You failed to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). Specifically, you stated during the inspection that you have not established component specifications [21 CFR 111.70(b)], in-process specifications [21 CFR 111.70(c)], finished product specifications [21 CFR 111.70(e)] or labeling and packaging specifications [21 CFR 111.70(d) and 111.70(g)] for any of your dietary supplement products. Once you have established the required specifications, you must verify that the specifications are met in accordance with 21 CFR 111.73 and 111.75, and you must make and keep records in accordance with 21 CFR 111.95(b).
Your response included a copy of a spreadsheet that you indicated is being designed, which documents the batch number, date, temperature and pH. This batch record template is insufficient in that it does not include all the elements required for a BPR, as provided in 21 CFR 111.260.
6. Your firm failed to register with the FDA as a commercial processor of LACF products. A commercial processor of low-acid foods in hermetically sealed containers is required, not later than 10 days after first engaging in the manufacture, processing, and packaging of thermally processed low-acid foods in any state, as defined in section 201(a)(1) of the Act, to register and file a Form FDA 2541 (Food Canning Establishment Registration) with the FDA, as required by 21 CFR 108.35(c)(1). However, our inspection indicates that your firm processes LACF products, including but not limited to, Sky High Chai Organic Liquid Concentrate, without an LACF registration with the FDA. Your response is inadequate (b)(3). LACF processors must register as commercial processors of low-acid foods, (b)(3). To date, your firm has not registered with FDA as an LACF processor.
Adulterated Conventional Foods - Unapproved Food Additives
Any substance added to a conventional food must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)].
Several of your liquid concentrates, coolers, herbal infusions, and bars contain substances that are food additives as defined in section 201(s) of the Act [21 U.S.C. 321(s)]. These substances include, but are not limited to, the following:
- Kava kava used in Cocoa Mystic Cacao Herbal Elixir Infusion Liquid Concentrate, Kava Chai Liquid Concentrate, Cooler Exotic Dream Herbal Enzyme Elixir, Cooler Around the World Herbal Enzyme Elixir, Euphoric Espress [sic] Herbal Infusion, Kava Chai Herbal Infusion, Mystic Wild Jun Bar, Kava Kava Pacific Herb of Peace and Spirit Up Natural Herbs of Spirit;
- Jatoba used in Mate Rainforest Chai Liquid Concentrate, Cooler Ginger Alchemy Herbal Enzyme Elixir, Cooler Cosmic Think Drink Herbal Enzyme Elixir, Blue Heaven Herbal Infusion, Epic Espress [sic] Herbal Infusion, Mate Rainforest Chai Herbal Infusion, Cup of Health Herbal Infusion, Rainforest Energy Jun Bar, Rainforest Energy Tonic Natural Herbs of Endurance, and Extreme Energy Natural Herbs of Wake-fullness;
- Pau d’arco used in Cocoa Mystic Cacao Herbal Elixir Infusion Liquid Concentrate, Mate Rainforest Chai Liquid Concentrate, Cooler Mate Way Herbal Enzyme Elixir, Cooler Exotic Dream Herbal Enzyme Elixir, Cooler Amazon Nectar Herbal Enzyme Elixir, Cooler Around the World Herbal Enzyme Elixir, Mate Rainforest Chai Herbal Infusion, Cup of Health Herbal Infusion, Sweet Vanilla Mate Herbal Infusion, Rainforest Energy Jun Bar, Immune Solution Jun Bar, Mystic Wild Jun Bar and Spirit Up Natural Herbs of Spirit; and
- Ginkgo used in Cooler Mate Way Herbal Enzyme Elixir and Cooler Cosmic Think Drink Herbal Enzyme Elixir.
FDA’s regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the view of qualified experts. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.
- Under 21 CFR 170.3(h), “[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance.” Under 21 CFR 170.30(b), “[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient.” Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.
- Under 21 CFR 170.3(f), “[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.” Under 21 CFR 170.30(c)(1), “[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information.” Importantly, however, the fact that a substance was added to food before 1958 does not, in itself, demonstrate that such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
- Under 21 CFR 170.3(i), “[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” The regulation provides that, in determining safety, the following factors are to be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and, (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).
9. Your Ginseng Journey Espress [sic] herbal infusion, Immune Solution Jun bar and Spirit Up tincture products are misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified within the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term “ginseng” may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Your Ginseng Journey Espress [sic] herbal infusion, Immune Solution Jun bar and Spirit Up tincture products contain an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be declared under a name that includes the term “ginseng” because it is not from the genus Panax. Although we did not review every product label or attempt to identify every misbranding violation, we noted that a number of your other product labels refer to ingredients that do not appear to be from the Panax genus as “ginseng.” You should review all of your product labels to ensure that the term “ginseng” is not used in a way that misbrands the product.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product, enjoin your firm from operating, and/or issue an Order of Need to obtain and hold a Temporary Emergency Permit.
- For your Ginseng Journey Espress [sic] Herbal Infusion product, if “Prince Ginseng” is not from the genus Panax, it may not be declared under any name that includes “ginseng.”
- Your Cosmic Think Drink Herbal Enzyme Elixir, Ginseng Journey Espress [sic] Herbal Infusion, Immune Solution Jun Bar, and Spirit Up tincture products do not list the street address of your place of business. The statement of the place of business shall include the street address, city, state, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory [21 CFR 101.5(d)].
- The ingredient statement for your Immune Solution Jun Bar product is not in the correct format. Currently, the product label contains two lists of ingredients, one for the entire bar and the other for the “Immune Solution” component of the bar. Because “Immune Solution” does not have an established common or usual name, it should not be listed as an ingredient of the bar (see 21 CFR 101.4(b)(2)). Rather, there should be only one ingredient statement on the product label and it should list all ingredients in the bar, including those that are components of “Immune Solution,” by common or usual name in descending order of predominance by weight in the finished product (the bar) (see 21 CFR 101.4(a)).
- We note that your Immune Solution Jun Bar ingredient statement declares “lecithin” as an ingredient. If this ingredient is from egg or soy, the ingredient statement does not meet the requirements of section 403(w)(1) of the Act, which states that specified allergens must be declared in the ingredient statement or in a “Contains” statement that immediately follows the ingredient statement.
- Your Field Trip Herbal Fusion Infusion product declares “stevia” in its ingredient list, but it is not clear from the ingredient list whether you are using stevia leaves, a crude stevia extract, or a purified extract in this product. If you are using stevia leaves or crude extracts obtained from stevia leaves in Field Trip Herbal Fusion Infusion or other conventional foods you produce, be advised that FDA considers these substances to be unsafe food additives when used in conventional foods (see FDA Import Alert 45-06, “Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and Foods Containing Stevia Leaves and/or Stevia Extracts,” www.accessdata.fda.gov/cms_ia/importalert_119.html). As explained in the “Adulterated Conventional Foods” section of this letter, the use of an unsafe food additive in a conventional food adulterates the food under section 402(a)(2)(C) of the Act [21 U.S.C. 342(a)(2)(C)].
However, FDA has reviewed GRAS notifications for the use of certain highly purified steviol glycosides obtained from stevia leaves as sweeteners in conventional foods, and has not objected to that use of these ingredients (see FDA Import Alert 45-06 for details on the composition and specifications of the highly purified steviol glycosides for which FDA has reviewed GRAS notifications without objection). If you are using such highly purified steviol glycosides in your product, please note that “stevia” refers to the botanical and is not the common or usual name of these highly purified ingredients. Rather, the common or usual name for highly purified steviol glycosides depends on the ingredient composition. If the sweetener is purified to contain 95 percent or more of a single steviol glycoside, the specific name of that single steviol glycoside is the common or usual name. For example, the name “rebaudioside A” should be used for ingredients with 95% or more rebaudioside A; the name “stevioside” should be used for ingredients with 95% or more stevioside. If the sweetener is purified to contain 95 percent or more of a mixture of two or more steviol glycosides, the name “steviol glycosides” would be the common or usual name.
- Your herbal enzyme elixir dietary supplement products, include both a Supplement Facts panel and a Nutrition Facts panel. Only a Supplement Facts panel may be shown on dietary supplement products, and therefore the Nutrition Facts panel should be removed. See 21 CFR 101.36.
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 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 re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Katherine L. Arnold, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Arnold at 425-302-0437.
Miriam R. Burbach