Men’s Single-serve Specialty Supplements
Men’s single-serve sexual enhancement supplements are abundant in the United States and have become fixtures at the counters of brick and mortar stores, convenience stores and are widely available from many on-line outlets. Retailers report male enhancement supplements are an incredibly profitable category with steadily-increasing demand. With this demand in mind, MaxLabs US (Washington, MI USA) initiated a national competitive analysis to assess feasibility of developing and introducing a disruptive product to this space. A broad comparative matrix was established and applied to dozens of product samples. Findings indicate 100% of the samples examined are non-compliant, fraudulent or mislabeled in some manner.
61 single-serve men’s sexual enhancement supplements were obtained from convenience/fuel outlets, adult novelty stores and on-line merchants across the United States during the months of June and July of 2016. Samples from each outlet and the accompanying receipt were cataloged upon arrival at MaxLabs US and sealed in labeled zip-closure bags that were subsequently placed in locked room temperature storage. Analysis included assessment of: Country of origin, supplement facts panels (SFP), business entity and UPC ownership status, weights and measures, expiration dates, lot numbers, FDA recall status, label compliance and relative value of content.
Weights & Measures- Tested samples were all of encapsulated dosage form (capsules for oral ingestion). Capsule sizes were verified via measurement of cap diameter and overall closed length using UltraTech® No. 1433 Calipers (General Tool, Secaucus, NJ). Weights of the intact (locked) capsules, their content alone and the emptied capsules were obtained utilizing calibrated M-prove® precision balances (Sartorius, Gottingen, Germany). Results were compared to the specifications of leading capsule manufacturersiii and a size for each sample was determined accordingly.
83.6% of capsules (n=51) were Size “00.” Capacity range ~900 to 910mg (at 1g/ml density).
13.1% of capsules (n=8) were Size “0.” Capacity ~680mg (at 1g/ml density) 3.3% of capsules (n=2) were other sizes including European standard sizes.
Note: One deformed sample measured as “00” but deformity resulted in out of range wt. (over).
4.9% of samples (n=3) had weights suggesting dense (pharmaceutical) content.
6.6% of samples (n=4) listed no weight of content whatsoever.
65.6% of samples (n=40) had secondary, implied weights (as high as 8,000mg).
68.9% of samples (n=42) listed weights physically impossible for the capsule size.
88.5% of samples (n=54) weighed, on average, 55.3% less than label claim.
Quality Assurance Indicator / Uniformity of Capsule Fill- 94.7% of the samples (54 of 57) that provided a weight on the SFP contained less material than stated which should be of concern to value-minded consumers. For brands of which multiple samples had been obtained, the range of content weights was graphed to evaluate the consistency of their manufacturing operations. There were 12 brands for which two or more samples were available. Variation across the 12 brands was observed to range from 1.2% to 28.2% (with an average 9.2%).
Snapshot of five tested supplements with the highest percentage variance across the samples:
|Product||# of Samples||Fill Variance (%)|
|Exten Zone 2000||5||16.4%|
|Rhino 8 8000||3||14.6%|
Even the best performing of these five products has a variation that’s more than 3 times what would be considered acceptable in a GMP-compliant nutraceutical manufacturing environment. This data could infer these products are produced under crude conditions and potentially filled via manual processes as opposed to automated encapsulation machinery. This variability is particularly troubling given the propensity of some manufacturers to incorporate undeclared pharmaceuticals and in such cases dangerous supratherapeutic dosages could be inadvertently prepared in the absence of effective quality control measures.
i www.capsugel.com, “Capsugel_ConiSnap_Sizing_Information” Capsugel, n.d. Web.
ii www.capsuline.com, “empty-capsule-size-chart” Ajix, Inc., n.d. Web