Male Supplements Are Coming Up Short / Part 2: Quality Control

Bad Pills Male Enhancement pills reviews series

Charles Kraft, R.N. is a Healthcare, Medical Device and Nutraceutical Expert.
He serves as V.P. of Functional Health at MaxLabs U.S.

 

In the first post of this series we discussed how loose enforcement of nutritional supplement standards has permitted massive fraud, particularly in the male sexual specialty category.  These supplements are experiencing record sales and ever-increasing demand, so it should be no surprise that opportunistic, fly-by-night manufacturers and product pushers have jumped-in.  Many are overseas companies not even legally operating in the United States, yet their goods are prevalent in this category.  We have specifically discussed how these unscrupulous producers are intentionally misleading, defrauding and endangering consumers on a grand scale.

Many are overseas companies not even legally operating in the United States

Deceptive labeling was revealed, with a shocking 89% of the popular supplements analyzed by MaxLabs US weighing an average of 55% less than what was stated on the packaging. Overall, 94.7% of the analyzed samples contained far less ingredient than was advertised on the packaging.  Today in Part 2 of this series we’re going to look at the variation of weight within some of these supplement brands as a quality control indicator to further illustrate federal oversight failing to adequately protect consumers.

 laboratory scales used to weigh male enhancement pills

Current Good Manufacturing Practices (cGMP) are FDA guidelines (21 CFR 111) followed by compliant supplement manufacturers that include numerous safeguards to ensure consistency of the supplements they produce.  They require production and testing of finished products in a manner that excludes the possibility of inadvertent contamination or tainting and assures the listed ingredients are precisely what's found in the finished supplement.  If a manufacturer follows these guidelines, multiple samples of the same brand supplement they produce would all contain nearly identical quantities of the listed ingredient(s).  When the capsules don’t contain similar amounts, it’s a clear sign that the manufacturer is not cGMP-compliant and does not have the accepted quality control measures in place.  In such cases the consumer isn’t getting a safe, predictable product.

When the capsules don’t contain similar amounts, it’s a clear sign the manufacturer is not cGMP-compliant and does not have the accepted quality control measures in place. 

Two or more samples were available for 12 of the men’s brands MaxLabs US analyzed.  Each sample was precisely weighed using highly-accurate laboratory scales.  As mentioned, a compliant supplement manufacturer would produce products with a weight consistent from one sample to the next.  A 3% to 5% variance is all you find with reputable products.  The reality with these bad pills is quite the opposite. Overall, these 12 sexual enhancement brands had an average variation well over 9%. This difference is roughly twice what is expected from a quality standpoint.  As if 9% wasn’t bad enough, the worst offender had a mind-boggling variation of 28.2% (around 7 times what good manufacturing practices would allow).  Keep in mind this variance in quantity across these brand’s is observed in addition to the fact the samples did not weigh nearly as much as claimed to begin with. So not only do these cheat the customer in terms of ingredient provided, they are also not filled consistently from one package to the next.  The chart below shows 5 male enhancement products with high rates of variation from package to package: bl4ck 4K, Exten Zone, Rhino 8, PowerZen and Stiff Nights.

 

Product

# of Samples

Fill Variance (%)

bl4ck 4K 6 28.2%
Exten Zone 2000 5 16.4%
Rhino 8 8000 3 14.6%
PowerZen 2 10.0%
Stiff Nights 2 9.6%

 

It should be noted that every brand listed on this chart has been recalled by the FDA at least once (recent dates noted): bl4ck 4k - 12/22/16, ExtenZone - 11/19/2013, Rhino 8 8000 - 12/22/16, PowerZen - 12/28/15 and Stiff Nights - 3/3/15.  Buyer beware when foreign manufacturers with loose quality controls dispense undeclared (and sometimes untested) active pharmaceutical ingredients.  Stiff Nights was recently implicated in the death of a Kansas City man.

What does this mean for US consumers?  It clearly shows these supplements are manufactured in sub-standard environments using non-compliant processes.  Capsules that are not uniformly filled can be the result of primitive or malfunctioning machinery or could even mean the capsules are filled manually.  Even in cases where older equipment or manual processes are used; cGMP-compliant producers would have quality assurance checks in place that prevent release of finished capsules with major variances in fill weight.  So not only are consumers getting far less than the labeled weight; it’s clear these fraudulent supplements are haphazardly slapped-together in plants outside U.S. jurisdiction without even the slightest concern for consistency.  A compliant, US-based manufacturer would never consider jeopardizing their reputation, credentials or public health by releasing products of such poor quality.

A compliant, US-based manufacturer would never consider jeopardizing their reputation, credentials or public health by releasing products of such poor quality.

The fact many of these brands have been called-out by the FDA for containing undeclared, unapproved (and often dangerous) pharmaceuticals is another tip-off compliant US-based manufacturers aren't the culprits.  These hazards coupled with the lack of quality control measures means these products aren’t just economically damaging to the consumer- they can also be life-threatening.  The risks associated with the intentional addition of pharmaceuticals to these male enhancement products (known as “adulteration”) is multiplied exponentially by this lack of consistency.  Consider that a consumer who tolerated an adulterated product at a lower level of content.  They might not be so lucky the next time, if sold a package that contains 25% more material.  Many hospitalizations and even death have been associated with adulterated dietary supplements, so it’s clear sale of these goods is not by any means "harmless" and manufacturers and retailers willing to sell such supplements are literally “playing God” with men’s lives- all in the name of making a quick buck.

 Profits drive sex pill manufacturers to sell adulterated sex pills

While the FDA frequently intercepts fraudulent supplements found in international shipments, these products need to be traced further upstream and more significant steps taken to curtail their flow.  A handful of large Chinese manufacturers are responsible for a significant portion of these dangerous, substandard and fraudulent pills.  While the FDA’s enforcement abilities are somewhat limited in this arena, it would be refreshing to see the US Attorney’s Offices take meaningful action against businesses that send their money abroad to purchase these “Bad Pills.” In addition to often containing dangerous undeclared and unapproved pharmaceuticals, being poorly manufactured and fraudulently labeled, they are almost without exception labeled as “Made in the U.S.A.”  The latter point should be of interest to the US Federal Trade Commission (FTC).

...they are almost without exception labeled undeserving as “Made in the U.S.A."                                                                                                             

All the details will be released in a January press release.  Finally, there is a US-based supplement company that’s taking quality assurance in men’s specialty supplements seriously. They are using pharmaceutical-grade manufacturing, brand name bioactive ingredients and rigorous testing protocols.  If you haven’t checked them out yet, it’s time to look at IMPRESS! Dietary Supplement for Men.

 impress dietary supplement for men

IMPRESS! is a U.S. Pat. Pend. 1600mg formulation that’s distributed by MaxLabs US headquartered in Michigan.  IMPRESS! is the most potent combination of premium bioactives ever provided in a single-serving supplement designed for male performance.  Check out their product launch video to learn more about what makes IMPRESS! the safe, effective, and trustworthy option.  Protect yourself and your wallet by choosing IMPRESS!

 

What have you observed in the supplement industry that makes you nervous? If you have any questions about any of the information we shared here, we’d love to hear from you! Please leave any questions, comments, or thoughts you may have on the supplement industry below in our comment section. You never know, your thought or idea might just inspire our next blog series!

0 comments

Write a comment

Comments are moderated