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# Balance of Nature Marketing Unapproved, Misbranded Drugs: FDA
- URL: https://www.fdaweb.com/balance-of-nature-marketing-unapproved-misbranded-drugs-fda/
- Published: 2020-02-04T12:00:00.000Z
- Updated: 2026-09-14T16:01:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146002

FDA says that its 2/4-2/8/19 inspection of Evig LLC, doing business as Balance of Nature, St. George, UT, found serious violations of the Federal Food, Drug, and Cosmetic Act in the firm’s manufacturing and marketing of Whole Fruit Foods, Whole Food Veggies, and Whole Food Fiber & Spice. A just-released 8/20/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evig-llc-dba-balance-nature-580888-08202019?ref=fdaweb.com) says that claims on the products’ labels and on the firm’s Web site and YouTube channel demonstrate that the products are drugs that are intended for use in the cure, mitigation, treatment, or prevention of diseases and that the products have not been approved by FDA as drugs.

The letter contains many of the claims made by the company for its products and says the products are not generally accepted as safe and effective for the uses and thus are considered unapproved new drugs. The agency also says the products are misbranded because they don’t bear adequate directions for use. In addition, it says, the products’ manufacturing violates current good manufacturing practice requirements for dietary supplements in that the company: 

- failed to implement a system of production and process controls to ensure the quality of the dietary supplement and that the product is packaged and labeled as specified in the master manufacturing record;
- failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing; and
- failing to establish and follow written procedures to fulfill the requirements related to product complaints.

The letter also lists several additional reasons why the company’s three products are misbranded. Evig was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation for each step and a timetable for completion of the steps. The company also was informed that FDA is authorized to charge for re-inspection costs.