[retiredguy123]

"FDA approved", "FDA cleared", "FDA authorized". These are phrases used by advertisers in thousands of TV commercials for medical devices and pills. Does anyone know what these phrases mean and why they use three different phrases? Why not make it perfectly clear to the public what the FDA has said about the products and whether or not you should buy them? Why do we need to decipher what the FDA has determined about the products? Why can't they just tell us?

[Altavia]

Beware of Marketing terms like: “FDA Registered” or “FDA Listed.” Those do not mean the FDA has approved, cleared, or authorized the product.


✅ FDA Approved – The FDA reviewed clinical evidence and determined the product is safe and effective for its intended use. (Highest level of review.)

✅ FDA Cleared – Used mainly for medical devices. The FDA determined the device is substantially equivalent to an existing legally marketed device.

✅ FDA Authorized – The FDA has permitted use under a special authorization (such as during a public health emergency) based on the available evidence.

Approved, Cleared, and Authorized each have a specific FDA meaning—they are not interchangeable.

(ChatGPT Summary Infographic)

[retiredguy123]

Thanks for the information. But, my point is that the average person watching these ads has no idea what the FDA has really said about these products. For example, what is the point of the "FDA cleared" designation? To me, it doesn't sound like the FDA has in any way endorsed the product. In my opinion, the advertisers are just using these terms to trick people that the FDA has somehow endorsed the product.

[Altavia]

Originally Posted by retiredguy123

Thanks for the information. But, my point is that the average person watching these ads has no idea what the FDA has really said about these products. For example, what is the point of the "FDA cleared" designation? To me, it doesn't sound like the FDA has in any way endorsed the product. In my opinion, the advertisers are just using these terms to trick people that the FDA has somehow endorsed the product.

Yes - just remember - the FDA does not endorse products. The FDA regulates products—it doesn’t recommend them.

In fact, the FDA discourages manufacturers from implying that FDA review is an endorsement.

These types of statements could draw FDA scrutiny if they imply an endorsement:

* “FDA endorsed.”
* “FDA recommended.”
* “Certified by the FDA.”
* “Chosen by the FDA.”

are generally misleading and may violate FDA advertising and labeling rules. They may take action for false labeling.

These are generally acceptable when accurate:

* “FDA Approved.”
* “FDA Cleared.”
* “FDA Authorized.”

A product can be considered misbranded if its labeling or advertising is false or misleading.

The FDA can take significant enforcement action if a manufacturer falsely implies that FDA review is an endorsement.

The point of FDA Cleared, most medical devices are reviewed through the 510(k) process. The manufacturer must demonstrate the device is SUBSTANTIALLY EQUIVALENT to a legally marketed (predicate) device.

I ask ChatGPT to prepare an Infographic describing that process to illustrate the complexity.



...

[OrangeBlossomBaby]

Originally Posted by retiredguy123

Thanks for the information. But, my point is that the average person watching these ads has no idea what the FDA has really said about these products. For example, what is the point of the "FDA cleared" designation? To me, it doesn't sound like the FDA has in any way endorsed the product. In my opinion, the advertisers are just using these terms to trick people that the FDA has somehow endorsed the product.

If the average person cares enough, then they can go to the FDA website and look up the product or ingredient in question.

Also wording matters. "Natural ingredients, including the FDA-approved Supercalifragilisticexpialidocious Enzyme #72" doesn't mean the PRODUCT is FDA-approved. It means that one singular ingredient is FDA-approved. The product could be total crap, or even toxic. But they'll push that one ingredient because they know there are lots of suckers who'll fall for "FDA-Approved" without checking with the source. And the source isn't the manufacturer. It's the FDA.

[blueash]

Consumer protection is not a priority at the moment. Regulators and inspectors are being fired or quitting as their roles are changed and the management of departments is seemingly serving something other than science and the public good. YMMV

[retiredguy123]

Again, the FDA should be helping the consumers to decide which products to buy. Instead, they seem to be helping the advertisers more than the consumers because of the confusing information they publish.

[Caymus]

Originally Posted by retiredguy123

Again, the FDA should be helping the consumers to decide which products to buy. Instead, they seem to be helping the advertisers more than the consumers because of the confusing information they publish.

Or just ban all adds.

Only publish the information in medical trade journals.

[Risuli]

Originally Posted by retiredguy123

Again, the FDA should be helping the consumers to decide which products to buy. Instead, they seem to be helping the advertisers more than the consumers because of the confusing information they publish.

As previously mentioned, the FDA's role is to regulate, NOT endorse.

[asianthree]

I have to explain this issue to my parents. Casually explain what their physician chooses, not listen to commercials on TV.

[OrangeBlossomBaby]

Originally Posted by asianthree

I have to explain this issue to my parents. Casually explain what their physician chooses, not listen to commercials on TV.

I don't watch commercials at all, I have an ad blocker on my browsers, and use a Facebook ad blocker on Facebook. So - nope. No ads. Even with Hulu +TV with ads - I see no ads, because I watch my TV on my computer, which has that adblocker. When I listen to YouTube videos while exercising, I press "skip" on my phone to skip the ads after the first 5 seconds to proceed to the music video.

HOWEVER - medical commercials exist to inform people of medications that exist, and a general summary of their purpose. Notice they all say "Check with your doctor to see if ABCGel is right for you."

That's the whole point. To get people to bring up the medication with their doctor, IF the patient has the illness that this medication is supposed to treat. And then, a conversation should ensue.

That's how I was able to quit smoking - because I saw a commercial for Chantix when it first came out. My doctor said I was a qualified candidate to try it. My insurance company covered the starter pack for free. I quit smoking 100% after the first week, before I ever finished the starter pack. I threw the rest of the starter pack in the trash. Been 100% non-smoker ever since, haven't even been tempted to go back to smoking.

[retiredguy123]

My pet peeve is "Balance of Nature". They have a lot of celebrities promoting the product, but if you listen carefully, they never say anything about what the product does or how it helps with anything. So, I guess they don't even need any FDA involvement at all. But, they seem to be making millions of dollars on people who will buy anything just because it is advertised by a celebrity. Go figure.

[Stu from NYC]

If I have to ask my doc if a pill we see on tv is right for me I am seeing the wrong doc.

[Altavia]

Originally Posted by retiredguy123

My pet peeve is "Balance of Nature". They have a lot of celebrities promoting the product, but if you listen carefully, they never say anything about what the product does or how it helps with anything. So, I guess they don't even need any FDA involvement at all. But, they seem to be making millions of dollars on people who will buy anything just because it is advertised by a celebrity. Go figure.

The FDA issued warning letters and a consent decree against Balance of Nature in 2023.


Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products | FDA

Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products


For Immediate Release:
November 16, 2023

Yesterday, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products until they come into compliance with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act.

The U.S. District Court for the District of Utah, Central Division has entered two consent decrees of permanent injunction against Evig LLC, of St. George Utah, and the company’s CEO, Douglas Lex Howard, as well as Premium Production LLC, of St. George, Utah, and its Manager, Ryan Petersen.

Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs. The FDA has not approved Balance of Nature products for any use, despite the company’s claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19. In addition, Evig LLC violated current good manufacturing practice (CGMP) requirements, which rendered its products adulterated dietary supplements. Evig distributes Balance of Nature dietary supplement products through Amazon, Walmart, and its own online store at www.balanceofnature.com.

Premium Production LLC and Mr. Petersen manufactured Balance of Nature products in violation of multiple CGMP requirements, such as failing to establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.

“This FDA action ensures that dietary supplements distributed to American consumers are appropriately labeled, lawfully manufactured, and prevents products that potentially put people’s health at risk with unproven claims to cure, treat or prevent a serious illness,” said Michael C. Rogers, the FDA’s Acting Associate Commissioner for Regulatory Affairs. “We previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements, and the public cannot have confidence that their products are what they purport to be. The FDA will continue to protect the U.S. public health by taking appropriate actions when companies violate the law.”

In 2019, the FDA issued warning letters to Evig LLC and Premium Production LLC after facility inspections identified CGMP violations at both companies’ facilities. The warning letter to Evig LLC also informed the company that a review of its Balance of Nature website revealed that its products as labeled were unapproved new and misbranded drugs because they were intended to cure, mitigate, treat, or prevent disease. Following the 2019 warning letters, FDA inspections showed that the firms failed to address the deviations and come into compliance with the FDA’s requirements. Based on the firms’ continued violations, the FDA pursued injunctions against the firms.

“Products intended to treat or cure diseases require FDA approval,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Dietary supplement makers also must abide by federal health and safety requirements. The Department will continue to work closely with FDA to stop the distribution of unapproved, adulterated, and misbranded dietary supplements.”

The consent decrees prohibit Evig LLC and Premium Production LLC from distributing or manufacturing products until they are in compliance with CGMP and labeling regulations. Under the consent decrees, both firms must hire CGMP experts, submit documents demonstrating compliance, and receive the FDA’s approval to resume operations. In addition, Evig LLC must hire a labeling expert to ensure their products are no longer considered new and/or misbranded drugs.

The U.S. Department of Justice filed the complaints on behalf of the FDA.


###

This case is often cited because it combined both misleading disease claims and significant manufacturing quality deficiencies, resulting in one of the FDA’s stronger enforcement actions against a dietary supplement company.

The Warning Letter

Evig LLC dba Balance of Nature - 580888 - 08/20/2019 | FDA

###

[retiredguy123]

So, 23 years later the product is going strong and making millions of dollars, and they still can't tell you what it does.