I can't even guess how many times I've written about our ridiculously inadequate laws that govern dietary supplements and how much useless and/or harmful crap is sold to unsuspecting consumers. Although many people will reflexively blame the FDA for the stuff being sold, that is not a fair criticism. Largely due to some cagey language in the Dietary Supplement Health and Education Act of 1994, the FDA can neither approve nor reject these products as if they were drugs (more on that later). Instead, the supplement companies are responsible for having evidence of the safety and efficacy of the products (See: Fox, Hen House). This is because, under the law, dietary supplements are treated as food.
This is just plain nuts. I've yet to hear a cogent explanation for why anabolic steroids (DHEA), male fertility supplements (e.g., yohimbine), colloidal silver, and jellyfish (Prevagen), all of which are sold on Amazon, are foods. If so, you have a strange diet.
What got Balance of Nature Off-Balance?
The sleaze that pervades the supplements industry is business as usual, so for a company to get into trouble, it has to go above and beyond, This one did.
The company's self-inflicted troubles didn't just begin. In 2019 the FDA issued a Warning Letter (a big deal to companies regulated by FDA) to Evig, the company that makes Balance of Nature products, which included the following: [emphasis mine]
On February 4 – 8, 2019, the U.S. Food and Drug Administration (FDA or we) inspected your facility located at 785 E. Venture Dr., St. George, UT (1). During the inspection, our investigator collected product labels and written material accompanying your products. In addition, we reviewed labeling on your firm’s website at www.balanceofnature.com and your YouTube channel at www.youtube.com/user/balanceofnature1. The inspection and our review of your product labeling revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.
What could have prompted such a warning? The big no-no that supplement companies play close to the line is whether their ads or labels make “drug claims” that define the supplement as a drug, something that is explicitly forbidden. Here's the FDA's definition:
The FDA defines a drug, in part, as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Did Evig make drug-like claims? Oh, yes.
Here is a smattering (there are many more) of labeling violations cited by the FDA in 2019.
- "Do you have an itchy, sore, or scratchy throat? Sprinkle the contents of 3-6 Veggies capsules into a cup of warm broth, stir together and drink...When flu, cold, or allergy seasons come around double up at the beginning and throughout the season" (Treatment)
- "Diabetics: Proven safe and effective for diabetics. Studies demonstrate that polyphenol compounds found in Fiber & Spice improve insulin sensitivity leading to improved insulin function.” (Mitigation)
- • From the video posted to your YouTube channel, How to Help Overcome Relapsing MS: The name of the video constitutes a claim that your products are intended for use in the cure, mitigation, treatment, or prevention of Multiple Sclerosis (MS). (Cure, mitigation, treatment, prevention)
The company's penchant for making medical claims in 2019 did not stop there. In July 2023 the company was ordered to pay $1.1 million – $250,000 to consumers, and $850,000 (civil penalties and investigative costs). What for? Once again, illegal claims.
Balance of Nature made claims that its products could prevent, treat, mitigate, or cure serious disease conditions, including diabetes, arthritis, heart disease, fibromyalgia, and cancer. The company went so far as to recommend that customers take 12 capsules each of its Fruits and Veggies supplements if they had been “diagnosed with life threatening illness[.]” Balance of Nature also used customer testimonials to make scientifically unsupported claims that the products could treat or cure disease conditions such as lupus, ulcers, gout, congestive heart failure, Hepatitis C, and multiple sclerosis.
Press Release, Office of the District Attorney, Sonoma County, July 26, 2023
And 2023 isn't even over
Only a few days ago Evig took another hit, this time from the FDA, also for labeling violations.
In a November 16th press release, CEO Lex Howard said that the company has voluntarily (please) entered into a consent decree with the FDA and Department of Justice. The company will no longer be able to make or sell its products (mostly sold by Amazon and Walmart) until it is up to snuff with provisions of the Federal Food, Drug, and Cosmetic Act. We shall see.
A couple of laughs
Most things can be funny if you look from the right angle. Here are two. The first is a sentence in the Evig press release.
"Evig remains committed to providing the same formulas consisting of high quality ingredients to help consumers supplement their diet with fruits, vegetables and fiber in dietary supplement"
Free image : Pexels whoiswasiq
Evig seems to have made no effort at all to obey the law, and such violations are not victimless crimes. Patients suffering from diseases such as Lupus, ulcers, congestive heart failure, Hepatitis C, and Muliple Sclerosis could suffer severe consequences, thinking that Evig’s quack remedies are treating their serious diseases, and avoiding proven treatments.
Then there's this.
"In a separate complaint filed the same day, the Justice Department alleged that Premium Productions LLC and the company manager’s, Ryan Petersen, violated the act by manufacturing adulterated dietary supplements."
I don't even know what else to say, so I'll keep my mouth (uncharacteristically) shut. Especially if any Balance of Nature products are in the vicinity.
NOTE:
(1) It is no coincidence that the company is based in Utah. The ghastly 1994 DSHEA that makes all this nonsense possible was pushed through Congress by Orin Hatch (Utah), where there is (surprise) a thriving supplements industry.
Josh Bloom
Director of Chemical and Pharmaceutical Science
Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. He holds a Ph.D. in chemistry.
