Source: https://quackwatch.org/cases/fdawarning/prod/fda-warning-letters-about-products-2014/naturall/
Timestamp: 2020-05-26 09:56:34
Document Index: 595507024

Matched Legal Cases: ['art 111', 'art 111', '§ 321', '§ 343', 'art 101', 'art 101']

FDA Warning Letter to NatureAll-STF Holding, LLC 1/31/14 | Quackwatch
FDA Warning Letter to NatureAll-STF Holding, LLC 1/31/14
Between May 30 and June 6, 2013, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 34 W Louise Ave., Salt Lake City, UT
. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation (CGMP regulation), Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Additionally, during the inspection our investigators collected for our review, the labels associated with many of your products. In December 2013, FDA also reviewed labeling on your website at the Internet address http://www.spinaltouchformulas.com
. Based on this review, we determined that you take orders there for Colostrum, Valerian-Plus, Wormwood, Black Walnut-Plus, Lung-Plus, Yucca-Plus, MSM Plus, White Willow Plus, Thymus-Plus Capsules, and Myrrh products which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs 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.
In addition, even if your Black Walnut Plus and Myrrh products were not unapproved new drugs, as explained further below, they would be misbranded dietary supplements within the meaning of section 403 [21 U.S.C. § 343] of the Act, and its implementing regulations in 21 CFR Part 101. Furthermore, your Iron Plus and Prostate Plus dietary supplement products are misbranded within the meaning of section 403 and 21 CFR Part 101. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at
1. You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient before using the component, as required by 21 CFR 111.75(a)(1)(i). Specifically, you did not conduct identity testing on the dietary ingredients Myrrh Gum Powder (batch number
(b)(4)) and Wormwood (Artemisia annua) (lot number SB12-H071566C) that were used in the manufacture of your dietary supplements.