Page 134 - JSOM Winter 2018

2018 when more than 90,000 products are on likely the mar- The former means acknowledgement of the notification with-
ket. Currently, the Natural Medicines’ database has at least out objection, but does not mean approval. The “Objection”
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130,000 product listed and this is not exhaustive. typically means the information submitted to the FDA by the
manufacturer did not “provide reasonable assurance that the
Although the FDA is responsible for information on product ingredient does not present a significant or unreasonable risk
labels, the Supplement Facts Panel, and promotional materials of illness or injury” or that the identity of the NDI was not
distributed at the point of sale, the Federal Trade Commission adequately characterized. Importantly, the law does not say
(FTC) oversees claims in advertising. For example, marketing “reasonable certainty,” as is required by the food safety com-
on the Internet, television, social media, and the like is over- munity and the concept of “generally regarded as safe” sub-
seen by the FTC. Over the past 10 years, several reports have stances. But, based on the Objection, a product containing the
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found that consumers are not well informed about the safety NDI is not supposed to be introduced to the consumer market,
and effectiveness of DSs and may have difficulty interpreting and the FDA could consider it an adulterated food. Introduc-
product labels. 12–14 In other words, clear deficits in consumer ing it into commerce could be a prohibited act and the product
knowledge regarding DS regulation and effectiveness have could be subject to seizure. Announcement of the NDIN is
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been identified. Without a basic understanding of the regula- made public after 90 days, so they can be tracked. 18
tory framework of DSs and potential concerns, SOF medical
personnel can neither guide nor effectively advise Operators, Once a DS is on the market, the burden of proof is on the FDA
who could be exposed to unnecessary risks without expert to demonstrate the DS poses an unreasonable health risk.
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guidance. Although most SOF units do have performance di- Because the FDA can restrict or remove a DS only after it is
etitians, the nuances, gray areas, and subtleties make navigat- clearly shown to be unsafe, it cannot act swiftly to protect
ing the topic difficult. Following are some key and important the public. In fact, it may take years after a product has been
regulatory points to be aware of. marketed and harm has occurred before it is finally removed. 20

First, DSHEA provided the authority to establish Good Manu- Another important regulatory tidbit relates to the distinct
facturing Practices (GMPs) for manufacturing products, which roles of the FDA and the FTC. As noted, oversight of DSs
means controls for production and processing must be in place falls under FDA’s general authority, whereas the FTC protects
and consistent, and raw materials and finished products must the public against deceptive advertising. Unfortunately, very
be tested. 15–17 Dietary supplements are also included under the few consumers know to which agency they should report con-
adulteration provisions, which means FDA can take enforce- cerns, so concerns may go unreported, yet both agencies need
ment actions against products not meeting GMP requirements. to be in the loop for learning about DSs of concern.
In addition, all DS manufacturers are required to register their
facility with the FDA. Although all DS manufacturers are re- Concerns and Risks Related to DS
quired to follow the FDA current GMP regulations and FDA
does inspect manufacturing plants, well more than half of Quality Control, Hidden Ingredients, and
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the inspections are issued a “list” of all conditions they ob- Tainted Supplements
served and believe may constitute violations of FDA-related Despite clear regulations, quality control for DSs may
Acts. In fiscal year 2017, each “list,” on average, contained range from nonexistent to very high; contamination, adul-
more than five problem areas: two common violations were teration, false labeling, and incomplete labeling are not un-
not establishing “product specifications for identity, purity, common problems. 16,21–34 The FDA does maintain a webpage
strength and composition of finished dietary supplement,” titled “Tainted Products Marketed as Dietary Supplements,”
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and/or not following “written procedures for quality control with sexual enhancement and weight-loss products being the
operations.” There is no way FDA can begin to inspect all fa- primary categories of concern on that page. Tainted, in this
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cilities, yet more than half of those inspected (if not more) are case, could be simply contamination or intentional adultera-
not in compliance with GMPs. Since 2011, no more than 36% tion. When the amounts of the ingredients are high (in mil-
of the total inspections received a classification of “No Ac- ligram levels), it is more likely adulteration, but when the
tion Indicated”; the remaining were classified as either “VAI: amounts are trace, it is probably contamination. Regardless,
Voluntary Action Indicated” or “OAI: Official Action Indi- the FDA webpage makes the following statement: “This list
cated,” wherein regulatory and administrative actions would only includes a small fraction of the potentially hazardous
be recommended. products with hidden ingredients marketed to consumers on
the internet and in retail establishments. FDA is unable to test
Second, all DS firms are required to submit serious adverse and identify all products marketed as dietary supplements on
events (AEs) to FDA. Although the product label must pro- the market that have potentially harmful hidden ingredients.
vide a contact telephone number to report the serious AE, and Even if a product is not included in this list, consumers should
reporting of AEs is mandatory for manufacturer, it is almost exercise caution before using certain products.” 35
impossible to know if companies are in compliance with this
requirement. Product categories have been found to be “tainted” with hid-
den prescription medications, nonprescription medications,
Third, DSHEA provided some minimal “premarket review” unapproved drugs, and/or Class 1 scheduled drugs. The lit-
for any new dietary ingredient (NDI) that was not on the US erature suggests that 15% to 25% of DSs touted to increase
market before 1994. The NDI notification process requires physical performance may contain banned or prescription
a manufacturer to submit a notification (NDIN) of any new drug ingredients that are not listed on the label. 24,36-39 Table
dietary ingredient to the FDA at least 75 days before market- 1 provides a listing of some of the many ingredients found in
ing. The FDA then has 75 days to respond, but they only supplements that were not on the label and can potentially
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respond with an “Acknowledgement” or an “Objection.” compromise military readiness.

132 | JSOM Volume 18, Edition 4 / Winter 2018