In 2015, the global market for brain-health supplements was estimated to have a value of $2.3 billion, and the market was predicted to grow to $11.6 billion by 2024. That’s a huge amount of money being spent on supplements that claim to boost brain health and function. Unfortunately, supplements are subject to very little oversight to be sure they can actually do the things they claim to do or to guarantee that they’re safe.
Brain-Health Supplements Make Bold Claims
The nutrition-store shelves are full of dietary supplements that make extreme claims about their ability to improve brain health and function, most of them not backed up by real, rigorous science.
- Ginkgo biloba is often said to improve attention, memory, and other brain function, but research aimed at substantiating these claims has been inconclusive.
- Huperzine-A, a chemical derived from moss, may aid memory in Alzheimer’s patients, but little research has been conducted to see if it does so in healthy people.
- Docosahexaenoic acid (DHA), a fatty acid found in fish oil, is important for basic brain health, and some marketing claims that it boosts learning power, too.
- Acetyl-L-carnitine may also improve memory function in Alzheimer’s patients, but there is no data that shows it improves memory in healthy brains.
- DMAE (2-dimethylaminoethanol) is said to increase levels of the neurotransmitter acetylcholine in the brain. There’s a lack of data that proves that it aids brain function, however.
How Supplements are Regulated
In 1994, the U.S. Congress enacted the Dietary Supplement Health and Education Act (DSHEA), which offered a new definition of dietary supplements and differentiated them from drugs. The DSHEA essentially classifies dietary supplements as foods rather than drugs and exempts them from most of the development and approval process to which drugs are subject.
The DSHEA does provide some restrictions for supplements, including:
- Dietary supplements must contain one or more ingredients that are considered dietary, such as vitamins, minerals, herbs, or amino acids.
- Supplements can’t contain any ingredients that have “a significant or unreasonable risk of illness or injury” when used as directed. However, it’s left to the manufacturer to determine the risk, or lack thereof.
- Supplements must be accurately and completely labeled in terms of their ingredients, and they must be identified as dietary supplements.
- The supplement’s label must contain a disclaimer that says the Food and Drug Administration (FDA) has not evaluated its claims of effectiveness.
How Supplements are Not Regulated
Because the FDA requires that supplements be based on dietary ingredients, they are often are built on substances that have not been proven to have any medical effect. Critics sometimes point out that supplements contain largely inert ingredients that are “as close to air and water as possible.”
The DSHEA, however, removes the regulatory requirements meant to ensure that drugs are effective and safe, leaving supplements significantly unregulated.
- Supplement manufacturers are not required to conduct clinical trials designed to test and prove the effectiveness of supplements, nor are they required to do testing to prove that the supplement is safe.
- The FDA can remove a supplement from the market only after the agency has proven that the supplement poses a significant health risk to users.
How Prescription Drugs are Regulated
In contrast to supplements, prescription drugs are subject to a lengthy approval process before they can be prescribed and sold to the public. The process typically takes about 10 years from its initial stages to introduction of the drug on the market.
- The initial phase of the process involves identifying a potential new drug and determining its correct dosage, ideal administration, and potential effects.
- Preclinical studies (often conducted in vitro or on non-human subjects) are conducted to determine if the drug is safe.
- Clinical trials are conducted in several phases to study how the drug works in human recipients.
- After a drug is proven safe and effective, the FDA reviews the research to judge whether the drug can be introduced to the market.
- After the drug is approved and introduced to the market, the FDA conducts post-market reviews to make sure that the drug is safe after it’s in widespread use.
The video below summarizes what a new drug has to go through before it can be legally sold in the U.S.: