Page 116 - JSOM Winter 2024

safe and not subject to review for safety by the FDA prior to mitigate symptoms became available, and the FDA sent out
being marketed. Any dietary ingredient marketed in the U.S. many warning letters. Over the last few years, the FDA has
after 15 October 1994 would be considered a “new dietary in- identified new categories of tainted products in products mar-
19
20
gredient” (NDI) and must be reviewed by the FDA; however, no keted for arthritis, pain management, or as sleep aids. The
authoritative list exists for dietary ingredients marketed as a DS FDA’s list of tainted products continues to grow.
before 15 October 1994. Therefore, manufacturers and distrib-
utors are responsible for determining if an ingredient is a NDI. 5 To build on this concept of quality, we completed the analyses
of at least 125 products marketed for brain health, weight loss,
Because of current FDA regulations, an almost never-ending and immune health. As shown in Table 1, only 25% of the
assortment of ingredients appear in DSs. In the U.S., DSs can labels accurately listed the ingredient content, at least quali-
be sold without any evidence of safety or efficacy, and many tatively. This means that 75% were misbranded. In addition,
thousands of products are available to American consumers product analyses identified hidden ingredients in 44 products.
through online and “brick-and-mortar” venues. Unsafe DSs Thus, 35.2% of the products were adulterated. 10–13,21
are sometimes hard to identify as there is limited to no re-
search on some DS products and ingredients. Additionally, DSs TABLE 1 Dietary Supplement Product Quality: Select Analyses
can be contaminated or adulterated; some contain prohibited No. (%) of
or potentially dangerous substances. Moreover, the FDA only No. (%) of products with
requires manufacturers to report serious adverse health events No. of products ingredients
resulting from DS intake; there is no requirement to report Type of dietary products with accurate detected but not
minor adverse events. supplement tested labeling listed on label
Cognitive performance/ 24 3 (12.5) 18 (75.0)
brain health
Although the FDA does what it can within the scope of the
law, the military is a prime target for predatory DS marketers. Immune health 30 13 (43.3) 9 (30.0)
These marketers know that Servicemembers want to be at the Weight loss/fat burner 30 5 (16.7) 7 (23.3)
tip of the spear for muscle strength, body composition, and Select products asked
physical and cognitive performance; essentially, Servicemem- about through OPSS’s
Ask the Expert Portal
6–8
bers want an edge. To achieve this edge, Servicemembers are (pre-workout, weight 41 11 (26.8) 10 (24.4)
more likely than civilian counterparts to use different types of loss, male enhancement,
DSs, especially combination products, proteins, amino acids, body building)
3
and less safe DS products. Notably, a substantial proportion Total 125 32 (25.6) 44 (35.2)
of Servicemembers (18%) report one or more adverse events OPSS = Operation Supplement Safety.
from DSs over 6 months, especially when combining products
and using prohormones. 9 Questionable and Non-DS Ingredients
Our analyses have detected performance-enhancing or cogni-
Many companies make outrageous claims and directly market tion-altering substances contained in categories of ingredients
to military members. They make statements that appeal to the or specific ingredients marketed as DSs. The emergence of these
military, such as “military grade,” “supplements designed for substances has posed challenges in terms of detection, enforce-
soldiers,” and “inspired by the real heroes, made for everyone.” ment, and education. Importantly, such products are more likely
Likewise, many manufacturers will send products purchased to cause harm than confer any performance or health benefit.
to any location in the world for free. Two critical concerns Some of these substances, including selective androgen receptor
include the quality of products marketed and the ease of ob- modulators (SARMs), peptides, tianeptine, and delta-8 tetra-
taining products with questionable and non-DS ingredients on hydrocannabinol (THC), are discussed in further detail below.
and around bases.
SARMs
SARMs were designed to activate androgen receptors in a very
Problematic Products
tissue-selective manner to promote anabolic effects without the
Product Quality unwanted side-effects of a more global modulator. Although
The likelihood is high that various DS products promoted to SARMs are often marketed as DSs or sold “for research use
Servicemembers and the public are adulterated, misbranded only,” they are unapproved drugs. These products often have
(labeled in violation of statutory requirements), or contami- no warnings on the labels, which may lead a consumer or Ser-
nated. 10–18 For example, the Department of Justice announced vicemember to believe the products are safe. Importantly, al-
on 12 January 2024 that a Texas Company pled guilty to though several SARMs are in preclinical and clinical phases
distributing misbranded DSs. The company, 5 Star Nutrition for patients with muscle wasting, breast cancer, or osteoporo-
LLC, agreed to a $4.5 million forfeiture. The company had sis, to date, no SARM has been clinically approved. 22
locations on or very close to key military installations, and
some may still be on bases in 2024. This is very concerning to Despite being unapproved drugs, SARMs are readily available
the public at large. online, both as ingredients in DSs and as research chemicals.
Some websites market these unapproved products for “research
Other products have repeatedly been shown to be misbranded use” or “research purposes only” but describe them with lan-
or adulterated. The FDA compiles categories of tainted prod- guage clearly targeting bodybuilding or performance- enhancing
ucts found to contain hidden ingredients not listed on the la- effects. In addition, the bottle may be designed to look like a
bel. Initially, problems were noted with bodybuilding, sexual DS while including labeling such as “Research Facts” (Figure
enhancement, and weight loss products. However, during the 1), “Research Chemical,” or “disclaimers” such as “not for hu-
COVID-19 pandemic, many products to boost immunity or man consumption.” Of concern is that when these compounds

114 | JSOM Volume 24, Edition 4 / Winter 2024