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Home » The Underregulated Health Supplement Industry
Supplements

The Underregulated Health Supplement Industry

adminBy adminJune 7, 2025Updated:June 7, 2025No Comments4 Mins Read
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Health supplements are a growing industry. Finding quality supplements to promote good health while minimizing harmful side effects is crucial, and seeking professional guidance is also recommended.

Be wary of supplements that purport to treat diseases or conditions; such promises are usually false and could potentially pose significant health risks.

Dietary supplements are a booming business

Even with limited oversight from the FDA, an unprecedented variety of supplements are being sold to consumers: herbs, amino acids, enzymes, concentrates and extracts. This uncontrolled industry puts consumers at risk by leading them down false paths about what their supplement intake means for them – potentially misguiding and harming their wellbeing in ways unintended by unfounded beliefs about these dietary aids.

Supplement businesses face fierce competition to secure their profits, with product offerings, distribution channels and pricing strategies all playing key roles in driving revenue growth. Furthermore, fast shifting consumer trends pose additional obstacles to their profitability.

Scott Dicker, Senior Director of Market Insights for SPINS, observes that consumers increasingly seek products made with natural ingredients. Beauty and mood support products such as ashwagandha and L-theanine have proven especially popular. Sports nutrition and meal supplement categories have seen growth due to an emphasis on healthy living and fitness.

They aren’t regulated by the FDA

Dietary supplements are not subject to FDA regulation in the same manner as drugs; therefore, they cannot make claims that they treat or cure diseases. Instead, dietary supplements may be marketed with structure/function claims such as “calcium builds strong bones” or “fiber keeps you regular.”

The FDA regulates dietary supplement production through Current Good Manufacturing Practice (CGMP), similar to pharmaceutical GMP but less stringent. These regulations mandate that all individuals involved with its development and production be held accountable for its ingredients, labeling accuracy and overall safety.

When receiving reports of illness or injury caused by supplements sold in the U.S., the Food and Drug Administration can stop selling them until further investigations can take place. They can send warning letters to manufacturers that violate these rules; and, if their responses do not satisfy the FDA, mandatory recalls can also be implemented as necessary to protect consumers from potentially hazardous ingredients.

They aren’t regulated by law

Dietary supplements don’t undergo the same rigorous safety testing requirements that pharmaceuticals do; rather, they’re treated more like food than drugs by the FDA and do not fall under their regulation as closely. That said, if one becomes unsafe they can still be removed from sale.

Dietary Supplement Health and Education Act of 1994 (DSHEA) establishes an outline for supplement regulation that is less stringent than drug legislation. For instance, supplements must not contain anything that poses any risk of illness or injury when taken as directed on their labels, and manufacturers are required to notify FDA if any harm results from using their product.

Supplements should not make claims that they treat or cure diseases; rather, they can reduce risk. Furthermore, supplements cannot include any substances considered active ingredients of other products (i.e. medications and drugs).

They aren’t regulated by science

Before any medication can be sold in the US, it must undergo extensive clinical trials and premarket approval processes. Unfortunately, supplements don’t go through this same rigorous approval process and many can even be sold without evidence of safety or efficacy – leading to potentially misleading marketing practices; for instance, some supplements are advertised as treating fatigue, stress and anxiety without providing evidence thereof; this has caused misdiagnosis which may prove fatal.

Although the FDA does not require pre-approval of health claims for supplement advertising, they are still regulated under truth-in-advertising laws and by the FTC’s requirements of credible scientific evidence for information about supplements. Before beginning taking supplements it’s a good idea to discuss them with both your physician and a dietitian in order to avoid false hopes that could interfere with receiving proper medical care.

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