Scam Watch: Finally Free Hair Removal System

The hair removal industry has continued to grow in recent years, thanks to newly developed treatments and technologies designed to remove unwanted hair on the face and body. While many successful hair removal options are available in a variety of treatment techniques and costs, there are also dozens of hair removal product scams out there, like Finally Free, which spout false claims of being "clinically proven," "painless" and "permanent". It's hard to know what to believe with so many choices of products and procedures on the market, but in the interests of promoting honest information about hair removal, we decided to take a look at this particular product that has rip-off written all over it.

Hair Removal Hoax

Finally Free markets itself as a permanent hair removal system that uses radio frequency waves to eliminate unwanted hair. The system can be purchased online on their "nevershaveagain" website, and comes with a choice of electric tweezers or patch applicators, which supposedly transmit radio waves into treated hairs. After applying the tweezers or patch applicator to hair for about "a minute or so," the hair will just "fall out" easily and painlessly.

In addition to the "painless" and "permanent" claims, Finally Free advertises itself to be as "equally effective" as professional electrolysis and "more effective" than laser hair removal. By further review of their posted clinical trials, we read that their independent study of the product was tested by 10, count 'em, 10 patients (most FDA Phase I clinical trials have between 20-80 test subjects). All 10 patients reportedly used Finally Free and needle-based electrolysis on a test patch of hair one time, then were evaluated weekly for 9 weeks.

There is no specific information given detailing specifics about the trials that would explain or extrapolate on their findings: we don't know the patients' ages, genders, hair types, nor do we know where the treatment was administered, or what these weekly observations entailed. We don't even know what the test patients' instructions were throughout the trial period, and what they did or didn't do during this time. The test patients could have been company employees for all we know!

At 9 weeks, Finally Free researchers claimed the results showed 60% of hairs treated once by Finally Free did not grow back. They also claimed that, by comparison, the needle-based electrolysis results showed 55.9% of hairs didn't grow back. Finally Free also reported on the higher level of pain experienced by electrolysis patients vs. Finally Free patients, and wrapped up this information to conclude that "electrolysis should never be used again since a safer equally effective alternative is available".

Why You Shouldn't Buy it (Literally or Figuratively)

When you get right down to the nitty gritty, Finally Free appears to be no more than a glorified electric tweezer set. Forget for a minute that the Finally Free Permanent Hair Removal System is listed as a scam on numerous hair removal information websites and forums, such as Hairfacts and HairTell; consumer complaints ranging from the product's complete ineffectiveness, to the company's unprofessional business tactics and inconsistency with refunds and order cancellations. By digging a little deeper, we found information from FDA rulings and reports that almost completely negate Literally Free's effectiveness and legitimacy as a hair removal product, and confirm the accuracy of these consumer warnings and rants.

Clinically Proven: False

The clinical studies listed on Finally Free's website were conducted by researchers in Denmark (we have no way of knowing if the studies were conducted or even overseen by licensed doctors), and published in a 1998 volume of the Journal of Skin Research and Technology (funnily enough, the journal's editor-in-chief is also from Denmark). In the journal’s abstract for this published study, it states that "the differences between the treatments were not statistically significant". In other words, their studies found no significant difference between the results to indicate that Finally Free is definitely more effective than electrolysis at achieving long-term hair removal.

Additionally, Finally Free’s published studies were based on trials regulated by the 1996 version of the Declaration of Helsinki; a policy set forth by the World Medical Association (WMA). The Declaration of Helsinki outlines an ethical code of principles for medical research involving human subjects, and has been revised several times since its creation. According to the ’96 version of the Declaration, Finally Free’s researchers weren’t required to do the following during their clinical trials:

• 1) Allow an unbiased investigation committee to monitor ongoing trials, have access to researchers’ monitoring information, or be presented with information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, and incentives for test subjects.
• 2) Publish or make publicly available negative as well as positive trial results. They also weren’t required to declare the sources of funding, institutional affiliations, or possible conflicts of interest in their publications.

Both of these provisions were added to the Declaration of Helsinki in 2000 when it was next revised. I’d say the absence of those requirements left some pretty big holes in Finally Free’s accountability when they published their clinical trials. So not only does this information call into question the overall ethicality of Finally Free’s clinical trials, we are left with no proven data from their studies to support their product’s claim of certain superiority over electrolysis.

Permanent: False

In 1998, the same year Finally Free claimed they were cleared by the FDA (in fact it was in 1997), The FDA began a reclassification inquiry to see whether previously cleared "electric tweezer-type epilators" should be changed from a Class III device to a Class I device. Before this reclassification ruling took place in 1998, electric tweezer devices, including Finally Free, had been cleared through the 501(k) approval process; a cheaper, quicker process that largely approved products based on their identified similarities to other previously cleared devices. In other words, Finally Free received its initial FDA clearing because it was similar to other approved hair removal devices, not because it was specifically approved for the purposes of permanent hair removal. The 1998 reclassification ruling called all of these electric tweezer devices back into question.

During the reclassification inquiry, the FDA received several comments stating that electric tweezer sets, like Finally Free, shouldn't be reclassified as a Class I device because of the products’ ineffectiveness, false promotional claims, or because of their potential safety risks. The FDA did rule that electric tweezer products would be changed to Class I devices, largely because of their low safety risk. However, these statements were included in the ruling:

• "FDA agrees with the comments that there is no body of significant information establishing the effectiveness of the device to permanently remove hair."
• "FDA acknowledges that there is no statistically significant data at this time to support promotional claims of permanent or long-term removal of hair through use of this device."

To truly be considered permanent, the FDA and most medical professionals agree that a hair removal product must accomplish this by "destroying the papilla of hair" at the root of the follicle where growth occurs. Studies also indicate that the hair itself is not an effective conductor of electricity. Thus, the claim that tweezers receiving a direct current can transmit a frequency through the hair shaft to effectively disable the root is completely unfounded. Finally Free may try to dodge the bullet by leaning on their radio frequency claim, but in truth they are just another electric tweezer scam.

Conclusion

To really achieve permanent hair removal, your best bet is still electrolysis. As one of the top methods of permanent hair reduction, laser hair removal is a close runner-up. Just remember, an at-home hair removal product that seems too good to be true, probably is. As a hair removal consumer, it’s always wise to snoop around, investigate claims and compare products; either on your own, or with the help of a hair removal professional.

References

• nevershaveagain.com
• hairfacts.com
• hairtell.com
• fda.gov/cdrh/
• wiley.com/bw/journal.asp?ref=0909-752X
• hhs.gov/ohrp/nhrpac/mtg12-00/h2000-1996.pdf

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