Friday, May 24, 2024

Exclusive: FDA Issued Dire Warning Letter to Major Radio Advertiser Balance of Nature Last August

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If you listen to AM radio, particularly in New York, vitamin supplement Balance of Nature is a ubiquitous presence. The company blankets radio stations with short ads and really long ones, leasing time for half hour infomercials seemingly on every station.

But what you don’t know is that back on August 20th, 2019, the FDA issued a dire warning letter to Balance of Nature. Basically, this is snake oil, and it’s sold by a snake oil salesman. “Doctor” Douglas Howard is in fact not a medical doctor, but has a certificate as chiropractor. He has no actual medical training. And yet Balance of Nature is presented as a cure for many diseases and conditions.

That Balance of Nature does make outrageous claims is only part of the FDA’s warning. The other part is that the stuff doesn’t work. It doesn’t do anything. Its combination of “fruits and vegetables” is ridiculous.

Dr. Ronald Hoffman, a long time radio doctor, says on his website: “Research indicates that the benefits of whole fruits and vegetables cannot be distilled down into a pill. Many of the health effects may be mediated by the impact of substantial portions of healthy fibers and associated phytochemicals on fostering a favorable intestinal microbiome, thus affecting metabolism, immunity, and even mood.”

The FDA warns: “…the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplement…You failed to implement a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, you have not established and implemented a system of production and process controls.”

The FDA letter to Balance of Nature states that the company makes dozens of claims about its products. They are all “misbranded.” The letter reads, in sum: “Your products are not generally recognized as safe and effective…”

Included in the FDA claims in the Warning Letter are citations from Balance of Nature’s YouTube channel. Since the letter, some of those YouTube videos– which implied that their products could cure MS, among other things– have been cleaned up. But the radio shows and ads appear not have been changed. One that I caught this morning claimed “cancer is preventable.”

You’ve been warned.

Balance of Nature products expensive, of course, averaging around $50 a bottle. An apple, orange, and banana cost around $3 at fruit vendors in Manhattan.

The FDA tells Balance of Nature: “You 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, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1).  Specifically, you do not have written procedures for responsibilities of the quality control operations and you do not document any of the required quality control operations for the processes you perform, such as approval of contract manufacturers, approval of raw material suppliers, approval of formulations, and approval of labels.”

So far, there is no follow up, and the FDA has not posted an update.

 

 

Roger Friedman
Roger Friedmanhttps://www.showbiz411.com
Roger Friedman began his Showbiz411 column in April 2009 after 10 years with Fox News, where he created the Fox411 column. His movie reviews are carried by Rotten Tomatoes, and he is a member of both the movie and TV branches of the Critics Choice Awards. His articles have appeared in dozens of publications over the years including New York Magazine, where he wrote the Intelligencer column in the mid 90s and covered the OJ Simpson trial, and Fox News (when it wasn't so crazy) where he covered Michael Jackson. He is also the writer and co-producer of "Only the Strong Survive," a selection of the Cannes, Sundance, and Telluride Film festivals, directed by DA Pennebaker and Chris Hegedus.
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