Men's Specialty Supplements: Guidance for the FDA
Last night was another late one at the MaxLabs US office as we gear-up for the full launch of our new supplement, but generally it was quiet. Then, at about 6:50PM ET the relative silence was interrupted by a long string of the familiar "Public Notification" emails from the FDA on adulterated male enhancement products (example pictured above). Many of the "alerts" involve products that have been the subject of of our "Supplement Alert" videos or that have been featured in our "Bad Pills" blog articles. Chinese-made brands such as bl4ck 4K pills and "Triple Green" are among the latest offenders. The US Food and Drug Administration's approach to managing the challenges with adulterated men's sexual specialty supplements is unfortunately laughable and suggests they need some no-nonsense advice.
We have spent considerable time in businesses where "compliance is King." FDA compliance in the Healthcare and Medical Device sectors is "do or die" and we believe that US-based nutritional supplement producers are, for the most part, doing a pretty good job of following the rules as well. We are familiar with the folks at the FDA and know they have good intentions, but our friends need a wake-up call. A wake-up call that would stop this mess once and for all. Here it goes: "Dear FDA, When it comes to the men's sexual specialty supplement category, you aren't policing compliant manufacturers- You are dealing with massive criminal importation of fraudulent, tainted and mislabeled pharmaceuticals."
Look closely at the red box (inset above) that mentions "international mail shipments." Also notice the US Flag and "Proudly Made in the USA" statement. It wouldn't seem that US-made supplements would have to travel by "international mail," but maybe that's too obvious? Time and time again the FDA posts such notices describing and picturing similar. Our pals at the FDA then proceed to dedicate precious time and our hard-earned tax dollars, testing these intercepted products to determine exactly what they have been adulterated with. The identified adulterants are then announced! Guess what FDA? In doing so, you aren't providing any public service other than making a shopping list for those hungry for said pharmaceuticals and driving sales for those willing to sell the adulterated products. Remember "Stiff Nights?" You made it famous with such a recall and the now-deceased David McElwee's children are fatherless because your approach is a miserable failure.
At MaxLabs US we spend considerable sums on laboratory testing of raw materials and finished goods analysis, so we know such testing is not cheap. Here are a few easy tips the FDA can follow to save OUR money on testing and curb the flow of adulterated male enhancement supplements into the U.S.:
- If it arrives from abroad and states "Made in USA"- Don't test. DESTROY!
Assess the labeling as required in the Code of Federal Regulations (CFR).
- No contact information for the manufacturer? Don't test. DESTROY!
- Non-compliant ingredient lists? Don't test. DESTROY.
- Bogus distributor and UPC ownership? Don't test. DESTROY.
- Quantity of material not consistent with label? Don't test. DESTROY.
I could go on and on, but implementing these 5 suggestions alone would curb over 95% of the fraudulent imported supplements, save millions of tax dollars annually and would actually serve to protect public health. FDA friends, the Chinese just cook-up a new brand or "series" of supplements every time you identify one as adulterated, but these "Bad Pills" could be stopped every time just by assessing these 5 things and seizing non-compliant products. The fraudulent supplements will always abuse "Made in the USA." They will always have non-compliant labeling. They will always have bogus manufacturer and distributor information. Quit testing this crap and supporting the fraudulent supplement industry. Start seizing it instead. Our video series will even provide you the Chinese manufacturers' names and locations if you are interested in doing something constructive.
In the meantime those who want to try a compliant product from an American company can try IMPRESS!