SERIOUS GAPS in Supplement Safety – Examples and Proposed Solutions

US vitamin, mineral, herbal, and dietary supplement regulations are over 25 years old. In 1994, the Dietary Supplement Health and Education Act (DHSEA) created a new category, dietary supplements .

Even This Law No Longer Adequately Protects the Public. The 1994 market of a few thousand products and 4 billion dollars grew to tens of thousands of supplements worth over 40 billion.

Now commonly called supplements , they raise concerns over new biological or herbal ingredients, most of which, despite DHSEA requirements, are not reviewed by FDA . Our country has a similar situation. Not considered drugs, supplements avoid rigorous premarket testing.

Loopholes, legal and linguistic ambiguity, and poor industry compliance allow most new ingredients without FDA safety assessment. This Oversight Failure Has Enabled Market Growth. Since 1994, 75 thousand new supplements entered the market, but FDA recorded required safety data for fewer than 250. No system determines how many new safe ingredients are in tens of thousands of products.

Striking Examples of Safety Risks

The risks are illustrated by a pharmaceutical stimulant added without FDA investigation to hundreds of exercise and weight-loss products , 1,3-dimethylamylamine (DMAA). Department of Defense (DOD) experts feared hemorrhagic stroke and sudden death. DOD banned stimulant sales on bases. Under pressure, FDA took an unusual step, banning 1,3-dimethylamylamine (DMAA) nationwide.

Manufacturers responded by reformulating products with new stimulants. They replaced DMAA with synthetic versions of herbal ingredients not traditionally consumed together and a new aegeline, higenamine, and caffeine combination, without FDA notification or safety data. A year after launch, OxyELITE Pro was linked to severe hepatitis affecting 69 people: 32 hospitalized, 3 requiring liver transplants, and 2 dead.

Companies claimed exemption from DSHEA safety notifications. The law exempts ingredients “used in the food supply in a form not chemically altered for food.” Intended for rare use, wording was unclear. It did not cover new chemicals, combinations, or synthetics, but FDA apparently allowed exploitation without safety submissions.

The Loophole Became the Exemption That Swallowed the Law. Manufacturer-friendly food safety experts developed an approach certifying unconventional new ingredients as “generally recognized as safe.” They Turned the Supplement into an Energy Bar or Drink. After a few months in the “food supply,” manufacturers claim the ingredient can be sold in supplements at any dose.

Reform appears overdue. For the first time, Congress members, many manufacturers, and scientists agree changes are needed for public safety.

We propose reviewing all new ingredients and effective systems monitoring every supplement. New dietary ingredient law is designed to ensure safety of newly introduced components.

Fortunately, stakeholders agree this loophole should close and all new ingredients receive FDA review before sale.

Our solution addresses inherent tensions between consumer safety and balancing interests. Practical reform should include three basic principles .

• First, manufacturers should submit every label so FDA can track products. Mandatory submission increases transparency and strengthens DSHEA enforcement. FDA could assign each a unique barcode or quick response (QR) code to track manufacturing problems and confusion.
• Second, manufacturers should submit basic safety data for every new ingredient. Ingredients should, for example, clearly specify citrus-derived bioflavonoids. Regardless of origin, other new ingredients require safety evidence before sale.
• Finally, mandatory listing and screening require aggressive enforcement to meaningfully protect consumers. New law must clarify FDA responsibilities and provide adequate structural and enforcement funding.

Meaningful DSHEA reform can create modern regulation providing access to safe vitamins, minerals, herbs, and supplements.

What Are Turkey's Herbal Product and Supplement Regulations?

In Turkey, herbal product preparation and marketing assessments follow the separate regulations of the Health Ministry and Ministry of Food, Agriculture and Livestock, formerly Agriculture and Rural Affairs, through different practices . In Turkey, food supplements are the responsibility of the Ministry of Food, Agriculture and Livestock. Under simplified applications, manufacturers or importers rapidly obtain permissions to market products.

Herbal products overseen by this ministry have no mandatory analysis requirement. Conversely, the Health Ministry's 6 October 2010 “Traditional Herbal Medicinal Products Regulation” assigned it licensing for traditionally used medicinal plant preparations with protective or therapeutic effects. Boundaries remain unclear. A medicinal plant product can be licensed as a drug in pharmacies while another from the same plant is sold as a supplement in a shopping center without oversight. Some supplements are also sold in pharmacies, but this does not guarantee safety. Approved by the agriculture ministry, they do not fully meet pharmacy-product requirements and are sold through company–pharmacy agreements. Pharmacy sale therefore does not assure full quality and efficacy.

Conclusion

Our press frequently reports concerns about supplements, slimming, dietary, and sexual performance products. The issue is not just unregulated production: safety largely rests on manufacturers' claims without drug-like oversight. This neglected market grows daily, aided by poor monitoring, nearing a public health problem. Patients often use products without telling doctors. We increasingly see drug–drug, drug–food, and drug–supplement interactions. When treatment underperforms, we wonder whether undisclosed supplements caused it. Supplement safety must be taken seriously here too; regulation can ensure safe access to vitamins, minerals, herbs, and dietary supplements.