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DSHEA: An Overview

Is the Supplement Industry Regulated?

YES. The federal government regulates the manufacturing, distribution, and advertising of dietary supplements in the United States.

How is the Supplement Industry Regulated?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 was passed in response to a massive outpouring of support in favor of dietary supplements from individual citizens as well as the dietary supplement industry. Its passage established certain foods as dietary supplements, removing them from the categories of drugs, foods, and food additives, and creating a new regulatory framework for supplements. DSHEA, and rules based on DSHEA, define how a supplement can be manufactured, and outline what can and can’t be said in connection with the sale of a supplement. More specifically, DSHEA clearly distinguishes supplements from approved pharmaceuticals, and limits the type of health claims that can be made about supplements.

DSHEA Creates a Framework for the Regulation of Dietary Supplements as Follows:

  1. Definition of a “Dietary Supplement.” Dietary supplements are defined as products intended to supplement the diet. They contain vitamins, minerals, herbs, amino acids, or other dietary ingredients, as well as concentrates, extracts, or any combination of these types of ingredients. They may be offered in a wide range of forms (capsules, tablets, liquids, powders, bars, etc.) but may not be marketed for use as a conventional food.
  2. Safety Standards. Dietary supplements are considered unsafe if they present an unreasonable risk of illness or injury under the conditions of use recommended on the label. The FDA has the authority to take a variety of enforcement measures against manufacturers whose supplements are unsafe or not in compliance with mandatory Good Manufacturing Practices (see more below). These enforcement measures include inspections that can result in voluntary compliance, voluntary recalls, warning letters, seizures and injunctions, criminal actions, and joint enforcement actions with the Federal Trade Commission (FTC).
  3. Good Manufacturing Practices. Good Manufacturing Practices (GMPs) are a comprehensive set of rules that manufacturers and distributors of dietary supplements must follow under DSHEA. GMPs regulate the manufacturing process from the very first stages of production through the completion of the final product. Among many other requirements, manufacturers must engage in monitoring throughout the entire production process to maintain adequate quality control. Manufacturers must test (or have tested) raw ingredients and finished products for identity, purity, strength, composition, and limits on contamination.
  4. New Dietary Ingredients. If a company plans to sell a completely new type of dietary supplement ingredient, also known as a New Dietary Ingredient (NDI), it must submit evidence to the FDA of its safety, and cannot market the ingredient for another 75 days. This is different than “premarket approval,” whereby the FDA must approve the supplement before it is sold. With NDIs, the supplement can automatically be sold after the company submits its evidence to the FDA and after the 75 day window has passed. However, if the FDA finds that the supplement is a safety hazard, it can take action against the manufacturer, including removing the product from the market.
  5. Health Claims. DSHEA heavily regulates what manufacturers, distributors, and marketers can say about a supplement on the bottle and in advertising. These rules cover what information must be on the product label, such as a detailed supplement facts panel that declares the types and amounts of ingredients in the bottle. The rules also cover what cannot be said, such as statements that a supplement can cure or treat a disease.

Why Do Some People Say the Supplement Industry is Unregulated?

Given that the above regulatory requirements are in place (and many others), it is clear that the federal government does closely regulate the supplement industry. Yet the myth persists among some in the public, in the media, and in academia that the supplement industry is unregulated. Why is this?

  • Oftentimes, people simply aren’t aware of all of the rules that are in place to regulate supplement manufacturers, distributors, and marketers. Other times, the supplement industry gets singled out, when in fact there is no perfect regulatory system. When it comes to the food system, for example, the FDA and other government agencies have to balance the cost of regulation against the cost of restricting access to food items for consumers. It is not uncommon for food products to be recalled due to adulteration or contamination, although no one would claim that the food system is unregulated.
  • Another reason is the fact that the FDA does not pre-approve supplements before they are sold. People sometimes interpret this as an absence of regulation, even though there are many legally binding rules covering NDIs, manufacturing quality and safety, and health claims. While it is true that NDIs can automatically come onto the market after 75 days, this fact alone does not mean that all the other rules, including the FDA’s authority to seize unsafe supplements, don’t exist.
  • In general, the FDA often doesn’t have the resources to comprehensively enforce the law. This explains, in part, why there are some companies that fail to follow federal regulations and escape the FDA’s notice until it is too late. These companies reflect poorly on the supplement industry as a whole and help support the notion that the supplement industry is unregulated, when the truth is that the industry is regulated by many federal laws and rules, and most major companies do have rigorous quality control measures in place.
Source: FDA

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