Summary

At least 40% of today’s synthetic compounds are inspired by plants used in medicine for thousands of years.

According to the World Health Organization (WHO), a solid 40% of prescription drugs and over-the-counter medications are based on plants that have been used in medicine for centuries. Drug companies study plants and create synthetic versions to secure patents that prevent competition and protect premium prices for as long as 20 years. Companies using natural plant materials are handicapped by patent law that considers natural materials to be “common knowledge”, or in the public domain.

There are no FDA-approved dietary supplements or vitamins

Despite the belief that drugs approved by regulatory agencies are safer, some of today's most widely-used and trusted drugs weren’t developed in pharmaceutical labs and were never FDA approved. When the FDA was formed, new regulations were not applied to aspirin to avoid disrupting access crucial for pain and fever relief. There are no FDA approved dietary supplements despite the science now supporting their importance in treating conditions like arthritis (glucosamine chondroitin, omega-3 fatty acids), anemia (B12 and iron supplements) and insomnia (melatonin).

Some of the most popular medications are not FDA approved

Low-dosage aspirin for preventing heart disease is the only FDA-approved use of aspirin. After approval in 1985, it was widely prescribed by physicians to reduce the risk of cardiovascular disease (CVD) in people age 60 or older whether they showed signs of risk or not. In April 2022, the US Preventive Services Task Force issued guidance against using low-dosage aspirin for heart disease prevention, indicating that the risk of bleeding far outweighed “little to no benefit observed in patients receiving low-dosage aspirin to prevent CVD”.

FDA approval is not a guarantee

Regulatory approvals are often based on very little data relative to the patient population size and length of expected use. For low-dosage aspirin, with a patient population about the same size as chronic pain sufferers, it took 37 years after FDA approval to gather the data indicating that it didn’t do much for heart disease, but introduced unnecessary risk of bleeding and stroke. This is just one example of how limited data handicaps regulators and clinicians in the regulatory approval process. Sensational cases like Oxycontin underscore another weakness. The data that the FDA uses to make critical safety and effectiveness rulings can be fatally flawed since it’s produced, selected and submitted by drug companies rather than by unbiased third parties.

Choosing quality supplements

In 1994, Congress passed The Dietary Supplement Health and Education act granting the FDA broad powers to establish regulatory standards for dietary supplements such as vitamins, amino acids, herbs, botanicals, organ tissue and more. Given the range of products encompassed by the law, FDA regulations are broad and ambiguous. Laws strictly prohibit making therapeutic claims without clinical data, but there are no standards or requirements for purity, ingredient sourcing, dosage or testing -- or for collecting field data like the 37-years of patient information needed to understand the risks and benefits of low-dosage aspirin.

Makers take advantage of a lack of regulatory specifics to lower standards for product quality, consistency and purity. Consumers often believe that all products are alike, so price becomes the most important purchase criteria. People are unaware that a lack of testing standards means that a product’s potency can vary 20% or more from batch to batch.

Choose makers that work harder to set standards for consistency with multiple labs and organic chemists across the country that verify tests for product potency, purity and safety. Look for published reports on their web sites. 

Be sure makers use natural plant materials rather than synthetics to formulate products. Since this category of products are not FDA approved, be sure ingredients are generally recognized as safe (GRAS). Ingredients with GRAS status from the FDA are commonly consumed as food. Data submitted by organizations like the Flavor Extract Manufacturers Association (FEMA) submit exhaustive test data demonstrating that ingredients such as beta caryophyllene, concentrated flavor extracts from natural fruits, herbs and vegetables, can be safely eaten by people without drug interactions or negative side effects.

Although dietary supplements may not work the same way for everyone, be sure they’re safe by looking for this information published by reputable makers.