Size Genetics FDA Status – The Misleading Label that May Tip Your Scales

Jul 30, 2021 at 6:02 am

The market for men’s health thrives off credibility and reputation. This is as true for home exercise equipment as it is for supplements… and especially items denoted as medical devices. Representing your product accurately, especially in the health field where you’re often ingesting a product or placing it in regular, often intimate, contact with your body, is extremely important. People can only build trust based on the conduct of a company, and their messaging. So today we’re going to take a look at a certain company, Size Genetics, who offer a certain product, a penis extender – or penile traction device – and examine how their messaging reveals a core aspect of their business practices that you will want to know when it comes time to hit that “Buy” button.

A short summary of penis extenders. If this is your first exposure to the notion of penis extension it’s worth noting that it is a proven concept with a considerable success rate. While the same cannot be said for pills and other methods, the gradual mechanical traction to extend the penis at the cellular level has a new century of scientifically confirmed results behind it. The roots of their invention lie in the medical industry – originally the traction device was made to ensure even rehabilitation to unfortunate souls who suffered an injury or endured the need for surgery on their most precious bodily member. In fact, penis extenders are still classified for sale as “medical devices”, which is why this article is especially relevant. Traction devices delivered such successful results in their medical rehabilitation application that their further purposes were soon investigated and exploited to satisfy an age-old demand from men and women alike: “more, more, more.”

So as popularity gave rise to an industry, safety and use practices were applied and that brings us to the discussion of the FDA – a generally trusted and authoritative administration meant to rubber stamp products relating to all health and nutritional matters in the United States, including products found under the designation of the medical category. FDA Approval is a vigorous, demanding process which involves many steps of confirmation, testing, review, time, and energy – and we should hope so. It doesn’t take too much imagination to consider what happens when unhealthy or even dangerous products are released for widespread distribution on a population too busy with work to research a chain of trust on every product they buy off the shelf or from their online carts. Most people see the term “FDA” on a product and assume whatever it is has passed these strict hurdles and is safe to consume/use/administer to themselves and their loved ones.

Size Genetics is a company that knows this as well as anyone, and sure enough right on their landing page is the term:

FDA Cleared Medical Device

SizeGenetics™ is a FDA Cleared Medical Device

But FDA “Cleared” the same as FDA Approved? To be clear: No, it is not. Size Genetics trades on their knowledge that flashing a badge with the letters F.D.A. will put potential customers at ease about their product, when in reality Size Genetics’ “FDA Cleared” designation is far, far removed from the FDA’s Approval.

So, what is FDA “Cleared”? Size Genetics has basically done the bare minimum to uphold their lawful obligations to register their medical device - they paid a meagre fee to be legally allowed to sell the product they’re producing in the United States. Other than the legally-required fee they paid to register a medical device for sale, they have received no scrutiny from the FDA nor has their product line gone through any safety or quality testing from the FDA. From the FDA website concerning Device Registration and Listing:

“FDA does not issue Registration Certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered and listed. Registration and Listing does not denote approval or clearance of a firm or their devices.”

FDA “Cleared” is not a term used by the FDA in any capacity. Size Genetics is using that term to falsely imply something they know the average shopper will glance over: “our product has endured the country’s strict regulatory review process to ensure your safety and healthy use”. In fact, what they did was paid an operating fee. This is not an accolade or option for them, it’s a requirement: “Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.)…are required to register annually with the FDA” (Title 21 CFR Part 807).

So what does this say about Size Genetics? A few things come to mind. A company selling a product to a customer base who are uniquely vulnerable to certain factors (i.e. privacy, trust) is using twisted language to seemingly imply a level of certainty about their product that they have no basis to claim. They’ve made up a term “FDA Cleared” which only describes that they paid a legally-required registration fee. By the logic that this information is relevant to inform their customer of their law-abiding practices, it is curious why they didn’t also list on the landing page of their website that they paid their electric bill, shipping invoices, and taxes for the recent fiscal year.

Size Genetics is name-dropping and doing so prominently, it’s one of the biggest blocks of text on their home page. And if they’re twisting this irrelevant-to-the-customer piece of information so brazenly, it makes one wonder what other information on their site is being twisted for deception. Perhaps there is nothing exactly false on the Size Genetics website, but after encountering this – at very least – misleading information as a greeting, how are we to trust that the rest of their product description is full forthcoming with the information we are really looking for in order to make an informed decision. In fact, there are plenty more misleading statements on the Size Genetics site. It’s worth a look for yourself to see if you can find the most obvious ones. It’s worth taking a look at how Size Genetics presents their product (knowing what you know about their FDA claim) and then reading the information provided by their main competitors. Who do you trust more?

What makes this issue more of a problem is the prospect that Size Genetics is doing worse than just trading on a claim which they have used carefully crafted to lure in less scrutinizing customers – the issue is that IF Size Genetics was aware of a problem with their product then how do you think they would handle it? If parts of their device were faulty and were liable to break and even cause injury, do you think they would responsibly notify all their customers and account for a full recall and replacement? If certain state or regional laws allowed them to avoid fulfilling this obligation, on technicalities, do you think Size Genetics would do “the right thing”? The misleading behavior on their homepage to the world clearly shows how they would handle it: with deception. When buying anything, you want to have a certainty that the money you are paying is being spent in return for some value. Customers deserve fair exchange, no economy can work for long if trust between the producer and the consumer cannot be guaranteed. It seems that Size Genetics is not a good-faith business in this regard. Do you think they are the type of company to follow through with any return policies that they could find legal loopholes to get out of? Is this the type of company you think holds your best interest, as their customer, in as high a regard as their profits? In the end, is this the type of company that is likely to reward your trust, or exploit it?

It's not a small market that Size Genetics operates in. Hopefully they’re not first brand you encounter, as there are plenty of companies shooting straight about what they offer, the results you can realistically expect, and some even offer guarantees. If, after deciding like a lot of men and their partners that you want to proactively tackle an all-too common bedroom issue, and you encounter this brand you’ll want to take an especially close look at their claims. You’ll want to consider how easy it is for them to get away with telling you each bit of information about their product, because there’s a fine line between false advertising and crafting carefully misleading language, and Size Genetics has mastered the blurring of those lines. With all the other options out there, you can quickly find alternatives from companies that take on your trust more as a duty than as a trophy. It’s not easy finding solutions to some of life’s most sensitive problems, and when buying a product – one that will be making contact with your most intimate area for extended periods of time – the most important factor at the end of the day is professional trust.

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