Introduction
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is a crucial legislation for anyone in the supplement business. It changed how dietary supplements are regulated and marketed in the United States. This guide simplifies the act into a more digestible format so supplement business owners can easily understand their obligations and the opportunities within the law.
Key Takeaways for Supplement Business Owners
DSHEA provides a framework that balances consumer access to dietary supplements with safety and information. As a supplement business owner, understanding and complying with DSHEA is crucial for operating legally and successfully in this space. This act empowers you to support your customers’ health and wellness while demanding responsibility in manufacturing, labeling, and marketing your products.
- Freedom to Market: You can sell dietary supplements more freely, but you must ensure your products are safe, and your claims are supported by evidence.
- Labeling Requirements: Your product labels must be clear, truthful, and compliant with DSHEA guidelines.
- GMP Compliance: Your manufacturing processes must meet the standards to ensure product quality and safety.
- Innovation Opportunity: New dietary ingredients can be brought to market, but you must first demonstrate their safety to the FDA.
What is DSHEA?
DSHEA is a 1994 law that sets the standards for dietary supplements. Before this act, supplements were regulated more strictly, similar to food additives or drugs. DSHEA provides a separate regulatory framework, recognizing their unique status.
DSHEA definition
- Short Title: The act is officially known as the “Dietary Supplement Health and Education Act of 1994.”
- Purpose: To regulate dietary supplements less stringently than drugs, acknowledging their role in nutrition and health promotion.
What DSHEA Recognizes
- Nutrition and dietary supplements play a crucial role in health and preventing diseases.
- Supplements can reduce the need for costly medical procedures by supporting health and wellness.
- Consumers deserve access to supplements and information to make informed health choices.
Definitions Of Dietary Supplement Under DSHEA
- Dietary Supplements are products intended to supplement the diet, containing one or more dietary ingredients (vitamins, minerals, herbs, etc.) and not considered conventional food.
DSHEA Compliance
Safety and Regulation
- The FDA must prove a supplement is unsafe before it can be removed from the market, shifting the burden of proof away from the manufacturers.
Labeling and Claims
- Supplements must be labeled correctly, including listing all dietary ingredients.
- Claims about nutritional support must be truthful and not misleading, with a disclaimer that the FDA hasn’t evaluated the claim.
New Dietary Ingredients
- Supplements with new ingredients (not sold in the US before 1994) must be reviewed by the FDA for safety before marketing.
Good Manufacturing Practices (GMPs)
- Supplements must be produced quality, ensuring they are safe and contain what their labels claim.
Literature and Information
- Providing scientific literature related to supplements at the point of sale is allowed as long as it does not mislead or unfairly promote a specific brand.
