Dietary supplements are becoming more widely used in the promotion of health and longevity. The widespread adoption of supplements and vitamins has brought forward many questions that consumers have about the quality and safety of nutritional supplements.
Here’s the scoop on the FDA’s role in the regulation of the vitamin and supplement industry.
What Is The FDA?
The FDA is the governmental agency that is in charge of overseeing the safety of foods and drugs that are produced and sold in the United States.
The agency also ensures the safety, efficacy, and security of veterinary drugs, biological products, tobacco products, medical devices, cosmetics, and products that emit radiation.
When you hear about a product being recalled on the news due to safety concerns, it’s most likely the FDA that issued the recall.
The FDA plays a vital role in consumer safety in many industries, but while they are tasked with enforcing regulations and laws, they don’t play a role in approvals for every industry that they regulate.
The vitamin and supplement industry is one of those industries that is regulated by the FDA, but uses private independent research laboratories to confirm safety and purity.
Why Aren’t Vitamins Approved By The FDA?
The FDA doesn’t play a part in the approval of vitamins and supplements because they aren’t categorized as drugs.
The FDA guidelines state that drugs are for the treatment, prevention, or mitigation of diseases. Clinical trials on humans are required to show that a pharmaceutical drug is safe and effective before the FDA allows drugs to be approved. Drugs must also be manufactured in safe environments and packaged to meet strict labeling standards.
Vitamins and supplements have been classified by the FDA to be for nutritional purposes only, so the approval process is not required, but the FDA regulates both finished dietary supplement products and dietary ingredients.
How Does The FDA Regulate The Vitamin And Supplement Industry?
The FDA is the enforcement and regulatory agency in charge of overseeing the supplement and vitamin industry.
What a company can claim about a product is regulated by the FDA. The agency defines and enforces what vitamin brands can say about their products and can enforce safety standards through prosecution, fines, product recalls, and consumer warnings.
To help the agency regulate the vitamin industry, the FDA has put in place Good Manufacturing Practices (GMPs) for companies to follow. Through inspections and product testing, the FDA determines if products are Generally Recognized As Safe (GRAS) and can force the removal of products that are found to not meet health and safety standards.
Why Was The FDA Created?
In the early 20th century there was little to no regulation or enforceable laws regarding food or drugs.
After many people were sickened or died from using products that were unsafe, public pressure mounted and politicians finally took notice. Congress passed the Food, Drug, and Cosmetic Act in 1938 after hundreds of children were sick and many died after using an experimental medicine a year earlier.
What Is The Food, Drug, And Cosmetic Act?
The 1938 law established quality standards for food, drugs, medical devices, and cosmetics manufactured and sold in the United States. The law also unveiled federal oversight and enforcement policies of these standards.
Food and drugs are categorized separately in the law, with drugs requiring more regulations and scrutiny from the agency than food products.
Because the agency considers supplements and vitamins to be for nutritional purposes only, they fall under the category of food for the agency’s approval processes.
Supplements And Vitamin Claims
The legalities of what vitamin and supplement companies can say about their products are dictated by the Dietary Supplement Health and Education Act of 1994 (DHSEA).
Supplements and vitamins categorization as “food”, means they’re subject to strict guidelines about what they can claim to treat, cure, diagnose, or mitigate.
Insinuating, implying, or otherwise stating that a supplement or vitamin cures a disease is a claim that would be red-flagged by the FDA.
A disclaimer is mandatory for dietary supplements if they make any claims about affecting the structure and/or function of the human body. So sometimes you’ll see warnings on labels that may fall under this category.
How Do I Know My Vitamins Are Safe?
The best way to know that your vitamins and supplements are safe and effective is to find a trusted brand that has GMP certification.
GMP certification means the manufacturer follows a strict set of protocols and procedures to ensure every batch of supplements are consistent and free from contaminants. The certification lets consumers know that the products they’re buying are manufactured under a strict set of guidelines and have passed a third party testing and validation process.
With GMP certification and by purchasing a brand like Manna that you know and trust, you can rest easy knowing that your supplements and vitamins are independently screened for purity and efficacy.For more information on Manna and how liposomal vitamins and supplements can provide enhanced absorption, click here.*