Dietary supplements, from vitamins and minerals to herbal products, are widely used by millions of people to support and improve their health. But are supplements actually safe? 

Although the FDA does not approve supplements in the same way they do pharmaceutical drugs, they play an active role in overseeing the quality and safety of these products to protect consumers. 

How Does the FDA Regulate Supplements?

Unlike prescription drugs, which undergo rigorous FDA approval before reaching the market, dietary supplements are regulated differently under the Dietary Supplement Health and Education Act (DSHEA) of 1994. According to DSHEA, dietary supplements are categorized as food, not drugs. This means that supplement manufacturers are responsible for ensuring their products are safe before they hit store shelves — not the FDA.

The FDA’s role is more focused on post-market regulation. This involves monitoring products after they are available to consumers. While they don’t pre-approve supplements, they take action when a product is found to be unsafe or if its labeling is misleading.

What the FDA Does to Ensure Supplement Safety:

1. Manufacturing Standards
   The FDA sets strict manufacturing standards for dietary supplements under Good Manufacturing Practices (GMPs). These regulations ensure that supplements are produced consistently, safely, and are free from contaminants. GMPs cover everything from ingredient sourcing to the final product’s packaging. Manufacturers must verify that their products contain the ingredients listed on the label and that those ingredients meet certain purity and strength standards.
   
   
2. Labeling Requirements
   Dietary supplements must be clearly labeled with ingredients, serving sizes, and nutritional information. Misleading claims, such as products that promise to “cure” or “treat” diseases, are prohibited. The FDA also requires a disclaimer that the product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease. This is an important distinction from pharmaceutical drugs, which must demonstrate safety and efficacy before FDA approval.
   
   
3. Adverse Event Reporting
   If a consumer experiences a serious side effect from a dietary supplement, the FDA encourages them to report the adverse event through the MedWatch program. Supplement manufacturers are required by law to notify the FDA if they receive reports of serious adverse events linked to their products. The FDA reviews these reports and can take action if a product is determined to be harmful.
   
   
4. Recalls and Enforcement
   When a supplement is found to be unsafe, misbranded, or falsely advertised, the FDA has the authority to take enforcement actions. This can include issuing warning letters, mandating recalls, or seizing products from the market. For example, supplements that are contaminated with harmful ingredients or those found to contain undeclared prescription drugs are often recalled. Additionally, the FDA collaborates with the Federal Trade Commission (FTC) to ensure that advertising claims made by supplement companies are truthful and not misleading.
   
   
5. New Ingredients and Safety Monitoring
   Supplement companies are required to notify the FDA if they plan to introduce a new dietary ingredient (NDI) that wasn’t marketed before 1994. They must provide evidence that the ingredient is safe for consumption. However, the FDA doesn’t directly approve these ingredients but reviews the safety information provided by the manufacturer. The FDA also monitors ongoing research and scientific developments to keep up with emerging safety concerns in the industry.

Are Supplements Approved by the FDA?

The FDA doesn’t pre-approve dietary supplements like it does to pharmaceutical drug products, but the FDA does take a hands-on approach in ensuring the safety of supplements by setting manufacturing standards, monitoring manufacturing and labeling processes, to ensure the safety of supplements once they are on the market. 

The supplement industry is also governed by other regulations like the Fair Packaging and Labeling Act, which mandates honest and transparent labeling practices.

Since supplements don’t go through the same FDA approval process as pharmaceutical drugs, many people mistakenly believe that supplements are unregulated, which is not entirely true. 

How to Choose Safe Supplements

As a consumer, here are a few tips to ensure you’re choosing safe, high-quality supplements:

• Look for Third-Party Testing: Choose supplements that have been tested by third-party organizations like USP, NSF, or ConsumerLab. These groups verify that the product contains what it claims without harmful contaminants.
  
  
• Check for FDA Warning Letters: You can visit the FDA’s website to see if any warning letters have been issued to supplement manufacturers for safety or labeling violations.
  
  
• Research the Brand’s Reputation: Stick to established brands with transparent labeling and a good track record in the industry. For new brands, make sure they are manufactured in a FDA approved facility following Good Manufacturing Practices (GMPs), go through 3rd party testing, and are free of contaminants like the ones on this list.
  
  
• Consult Your Doctor: Always talk to your healthcare provider before taking a new supplement, especially if you’re pregnant, nursing, or taking prescription medications.

BEST supplements are formulated with the most effective, science-backed ingredients out there, and nothing else. No fillers, no false promises, and no B.S.

Just the right doses, delivered the right way, with results that actually matter.
Because your BEST health starts with the BEST standards. And we’re here to deliver both. 

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.