MaxLabs US / IMPRESS!® Dietary Supplement
Charles Kraft, R.N.
BACKGROUND & OBJECTIVES
Dietary supplements marketed for male sexual enhancement in the United States can be broadly categorized into two groups based on the products’ suggested dosing regimen. One group of these supplements is generally packaged in boxes or bottles with labeling that suggests the supplement be taken daily on a routine basis.
The second group, we refer to as the “single-serving” category, is predominantly found on retail display cards and are intended for periodic consumption on an as-needed basis prior to sexual activity. This research project focuses on the single-serving category of male enhancement products (examples of evaluated products below).
Robust demand has fueled introduction of many brands found to be adulterated with undeclared active pharmaceutical ingredients, some of which are banned and/or untested chemicals. The FDA has issued many warnings on the risks of taking these tainted products and published literature confirms they result in thousands of hospitalizations each year.
The tragic alleged death of a Kansas City man after taking one of the recalled (and studied) brands further underscores the perils to public health.
Data from the FDA Medication Health Fraud page reveals 355 recalls of supplements from the “Sexual Enhancement” category from March 2007 through December 2016. It should be noted each of these actions appears the result of testing for adulterants- an expensive, time-consuming process. Supplement manufacturers’ responsibilities extend well-beyond providing consumers finished goods that are free from harmful, undeclared chemicals.
This study evaluated 39 popular brands of single-serving male enhancement products and applied a broad matrix to determine if fraudulence (that should potentially preclude sale of these brands in the U.S.) extends past adulteration and into other more easily assessed compliance and consumer protection concerns.
Under current FDA guidelines, 95% of the 39 assessed brands would be considered unfit for sale in the U.S. by virtue of gross non-conformance to established labeling and quality indicators.
The overwhelming majority of these products show numerous traits indicating they are fraudulent by design- listing impossibly-high net weights, providing erroneous distributor information and misrepresenting country of origin among the findings.
ELEMENTS OF ANALYSIS
Compliance with FDA Labeling Requirements
- Net weight of content / ingredients
- Identification of ingredients
- Distributor Information- Name and complete address
- Country of origin
- Stated vs. actual ingredient weight
- Weight variance from sample-to-sample
- Presence of misleading information
Labeling | Net Weight of Ingredients
- 6.6% List No weight for content
- Regulation violated: 21 CFR 101.105(a)
Labeling | Use of "Implied Weights"
- 65% display misleading numbers (in thousands) listed on the package
- Numbers portrayed as MG weights on websites and by store clerks
- These numbers are greater than actual weight in 100% of samples
Yellow circles show examples of "Implied Weights" on Supplements
Labeling | "Impossible Weights"
- 68.9% claimed weights impossible for the provided capsule size
- Up to 5 times capsule capacity claimed in some cases
Capsules known to have capacity of about 900mg (botanical extracts)
Supplements claiming to contain 1100mg & 3000mg
Weight | Actual vs. Listed
All samples were weighed on a precision laboratory scale in 3 phases. 1) Capsule weighed unopened, 2) Content of capsule weighed and 3) Empty capsule weighed. Empty capsule weight obtained to ensure any residual content was not sufficient to take capsule beyond it's normally expected (empty) range.
- 88.5% of samples weighed an average of 55.3% less than label claim.
- 95% of the samples weighed less than stated on the label.
Weight as a Quality Indicator
It would be expected that multiple samples of a single brand would be of approximately the same weight. Five brands for which multiple samples were obtained had weight variation across specimens ranging from about 10% to as high as 28.2%. The lowest end of this range is more than twice what would be considered acceptable by a compliant manufacturer.
These products are not produced under the strict quality control that would be expected from FDA-compliant manufacturing.
Label Compliance | Contact Information
The Fair Packaging and Labeling Act (FPLA) is administered by the FDA when it comes to dietary supplements. The FPLA requires each package of these products to bear a label on which the name and place of business of the manufacturer, packer, or distributor is listed along with a complete mailing address (per 21 CFR 101.5).
- 97.4% (n=38) of the 39 brands do not provide the required address
- 15.2% (5) brands list no manufacturer or distributor
Research of Listed Distributors
The fact all but one of the brands did not comply with FDA address requirements prompted an investigation of the provided distributor names. The 39 brands listed a total of 30 different distributor names. A juris doctorate-trained legal researcher investigated pertinent government records to determine whether the distributors are legally operating business entities and discovered the following:
- 94% of the listed distributors are unregistered, fictitious businesses
Research of UPC Code Owners
UPC Ownership: The 39 individual “brands” were marked with a total of 40 unique UPC codes. Ownership of each UPC code was determined utilizing the industry standard GS1 UPC database.
- 2.5% (n=1) of UPC codes is invalid / assigned outside the United States.
- 5% (n=2) of the UPC codes return no ownership information.
Of the 37 remaining UPC codes for which ownership information was returned by the GS1 database; the information reveled a total of 20 owner entities. Research of the listed UPC owners via state business entity records reflect the following:
2.7% (n=1) of the UPC codes is registered to a Canadian entity with no website.
2.7% (n=1) of the UPC codes is registered to an individual in Seattle, WA.
5.4% (n=2) of the UPC codes belong to businesses that deny using the codes.
85% (n=17) of the UPC codes belong to entities for which no current data exists.
Country of Origin
Country of origin is important since Americans pay more for U.S.-made products to support the economy and attain higher quality product, along with the implied expectation of FDA oversight. 92% of the studied sexual enhancement products stated “Made in the USA” on the package or carried other indications of domestic origin such as an American flag.
U.S. production of most of these products cannot be proven and would be highly improbable given the fact it would be nearly impossible to conceal large-scale, non-compliant operations from view of authorities for the length of time these products have circulated. Chinese manufacturers including: Shenzhen Jinyuanquan Trading Co., Guangzhou Dongyao Trade Co. and DEX International Trading (HK) Co. export these deceptively-labeled brands in bulk and advertise them openly with over 66% of the studied brands appearing on the “Made-in-China” and “Alibaba” trade portals.
Chinese manufacturing also aligns with the FDA’s documented interceptions of adulterated sexual enhancement pills in international mail shipments. These Chinese-producers publish product descriptions, often with pictures of their packaging invalidly adorned with the American flag. Unfortunately, the fraudulent imports comprise most (and in some cases, all) of the supplement offerings at many U.S. retail outlets we visited. In addition to providing a fraction of the labeled content and no accountability, abuse of the “Made in the USA” label is yet another misleading marketing tactic being used on American consumers.
Fraudulent Chinese-made products dominate the U.S. single-serving male sexual enhancement supplement category, representing the majority of units sold at many retailers across the country. As this analysis clearly demonstrates, these pills do not comply with many of the most basic standards- Standards most US-based producers treat as "Bibles" that dictate their day-to-day operations.
Additionally, it is clear they endanger public health, but unnecessarily so. Simply screening inbound products for appropriate country of origin markings would alone curtail over 2/3 of these fraudulently-labeled products without incurring the time and expense of laboratory testing. Consumers and compliant U.S.-based supplement makers like MaxLabs US would appreciate it.
The 39 brands tested include:
72HP, alpha man extreme, bl4ck 4K, black 3K, BLACK LION, BLACK MAMBA 2, BLACK MAMBA 7K, BLACK MAMBA PREMIUM, BLACK PANTHER #1, BLUE Diamond, COCKSTAR, DIAMOND EXTREME 2000, DIAMOND EXTREME 4500, DIESEL FUEL, Exten Zone 2000, Exten Zone 3000, Exten Zone 5000, ExtenZone 2000, EXTREME MAMBA, FURY, Galaxy, MOJO RISEN, NITE RIDER, One More Knight, PowerZen, RHINO 11 BLACK 7000, RHINO 7 Platinum 5000, RHINO 8 8000 Platinum, RHINO THRUST, RHINO-V5, RSE7EN, S.W.A.G., STEEL, STIFFNIGHTS, SUPER PANTHER 7K, TITAN, TRIPLE GREEN, X MONSTER, xplozion and XXX Zone Platinum.
Sponsored by IMPRESS!
All results on file at MaxLabs US
Full graphed results with retailer, pricing data and other details will be released soon.
1. Emergency Department Visits for Adverse Events Related to Dietary Supplements, Geller, A, et. al., N Engl J Med 2015; 373:1531-1540. October 15, 2015.
2. Potts Law Firm. (2016). Settlement Reached over Death Alleged from Arousal Pills. [Press release]. Retrieved from http://www.prnewswire.com/news-releases/settlement-reached-over-death-alleged-from-arousal-pills-300340417.html
3. United States Food and Drug Administration. (2016). Tainted Products Marketed as Dietary Supplements_CDER [Data file]. Retrieved from http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.