Two things can be true at once: Balance of Nature is one of the most-purchased supplements in America, and it has one of the most extensive recent regulatory files in the industry. Here is that file, in order.
The timeline
| Date | Event | Documented by |
|---|---|---|
| Aug 20, 2019 | FDA warning letter to Evig LLC dba Balance of Nature, citing marketing that presented the products as treatments for disease — claims that would render them unapproved new drugs. | FDA warning letter (fda.gov) |
| 2019–2023 | Marketing continues; the government later alleges in court filings that violations persisted after the warning letter, including claims referencing cancer, heart disease, cirrhosis, diabetes, asthma and COVID-19. | DOJ/FDA injunction complaint |
| Oct 2023 | Government moves against the products — the FDA cites manufacturing violations, unsupported health claims and ingredient-verification concerns in seeking to halt distribution. | Court filings; contemporaneous press reporting |
| Nov 16, 2023 | Federal consent decrees entered against Evig LLC (distributor) and Premium Production LLC (manufacturer): production and distribution halted until compliance conditions met; independent cGMP experts required; a labeling expert required for Evig; ongoing complaint-handling and compliance obligations. | FDA press announcement, Nov 16, 2023 |
| Nov 2023 | Sales stop. The court-ordered pause takes effect; orders and shipping are suspended. | Company statements; press reporting |
| Dec 1, 2023 | Back in business. The company announces a return to “normal operations and shipping timelines” after implementing a plan to address FDA concerns, working with independent specialists. | Company announcement; CBS News, Dec 1, 2023 |
| Oct 27, 2025 | Class period closes for the $9.95M settlement of Morris v. Evig LLC (Phelps County, Missouri) — alleged misrepresentation of health benefits; purchases from Mar 28, 2019 through this date qualify. Company admits no wrongdoing. | Settlement administrator; court docket |
| Mar 6, 2026 | Final approval hearing held on the settlement (claim deadline: March 11, 2026 — now passed). We are confirming the final outcome and will update this entry. | Settlement notice — our full settlement explainer |
What this record does — and doesn’t — mean
What it means: the government formally corrected this company more than once, in escalating steps — a warning letter, then a federal injunction case, then consent decrees that stopped the business until it changed. The decrees included findings-level allegations about manufacturing practices, including failures to establish ingredient specifications — which matters directly to the question our 35/100 review centers on: what’s actually in the capsules, and in what amounts.
What it doesn’t mean: a consent decree is a compliance mechanism, not a product-safety verdict. The companies met the conditions to resume operating and remain under expert-monitored obligations. There is no public finding that current bottles are unsafe — and we’ve found no published third-party testing documentation proving what’s in them, either. Both halves of that sentence belong in any honest account.
The lesson for any supplement label
This record is why our methodology weighs testing transparency at 20 points: by the time a regulator acts, customers have been buying for years. The protections available to you before a court gets involved are on the label — disclosed amounts, named testing standards, dated prices. Products that publish them give you something to verify; products that don’t are asking for the kind of trust this timeline complicates. Our alternatives page applies exactly that test.
Frequently asked questions
Did the FDA shut down Balance of Nature?
Temporarily, in effect: the November 16, 2023 consent decrees halted production and distribution until compliance conditions were met. The company announced a return to normal operations by December 1, 2023.
Is Balance of Nature FDA approved now?
No supplement is FDA approved. The companies resumed operating after meeting decree conditions and remain under ongoing compliance obligations. A consent decree is not an endorsement — and not a finding that current products are unsafe.
What were the disease claims about?
Court filings alleged marketing that referenced treating or preventing serious conditions — including cancer, heart disease, cirrhosis, diabetes, asthma and COVID-19 — which would make the products unapproved new drugs under federal law.
Where can I read the original documents?
The FDA’s November 16, 2023 press announcement and the August 2019 warning letter are on fda.gov; the settlement documents are on the settlement administrator’s site. Sources below link the record.
Sources
- U.S. FDA — Warning letter to Evig LLC dba Balance of Nature, August 20, 2019. fda.gov
- U.S. FDA — press announcement, “Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products,” November 16, 2023. fda.gov
- CBS News — “Balance of Nature says it is back in business after FDA shutdown,” December 1, 2023 (restart date; decree requirements; October 2023 enforcement context).
- Evig LLC — company statement, “Evig, LLC dba Balance of Nature Finalizes Terms of Consent Decree with the U.S. FDA.” balanceofnature.com
- Morris v. Evig LLC dba Balance of Nature, Case No. 25PH-CV-01551, Circuit Court of Phelps County, Missouri — $9.95M settlement (class period Mar 28, 2019 – Oct 27, 2025; claim deadline Mar 11, 2026; final approval hearing Mar 6, 2026).
Update history
- July 14, 2026 — Timeline first published; record verified this date. Settlement final-approval outcome to be confirmed and added.
Content is for informational purposes only and is not medical or legal advice. Medical disclaimer.