How Does the FDA Regulate the Supplement Industry?


So, you’ve decided to go into the growing supplement industry. The Federal Drug Administration regulates food and drug products including supplements. However, how they regulate is different than either food or prescription drugs.

FDA Regulation

In 1994, the Dietary Supplement Health and Education Act went into effect to regulate the supplement and vitamin industry. FDA approved vitamins must meet certain safety and labeling guidelines. The FDA also regulates the facilities the supplements and vitamins are manufactured within. Consumers and other industry professionals can report misbranded or adulterated products to the FDA. The agency then follows up on the product. Adverse effects and complaints are also reported to the FDA for follow up. Taking the time to thoroughly read through and follow the industry guidelines the FDA uses can save you money and time later.

Industry Information

The Federal Drug Administration has a bunch of information for industry professionals that are invaluable for those just starting out. Before creating your own private label supplements, it is a good idea to know exactly what the FDA requires of your firm. Before creating labels, you need to know who you plan to use to manufacture the product, the ingredients and any company information you want to include. The agency provides guidance, forms and applications necessary to get started and stay compliant.

Dietary Labeling

One of the key items the FDA regulates are the labels on the products. The label must include information on the company, health claims, ingredients and nutritional content. Each of these items has its own guidelines for what to include on your own label. Trans fat is a requirement since July 2003 for any amount over 0.5g. The nutritional labeling must be included as with any food product. Dietary ingredients, chemical preservatives, daily values, expiration dates, antioxidant claims, artificial flavors and colors, extracts and additives are examples of some things to include on your supplement label.

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Health Claims

Health claims are part of the labeling guidelines. Types of health claims include “good source” claims, “healthy” claims, “more” claims, “Lite” or “Light” claims, “antioxidant” claims and implied nutrient content claims. The labeling guidelines for health claims focus on how they are listed on the label such as type size and location. A disclosure statement is required when you make any claim about the nutrient content of your product. The FDA requires a daily value of 20% for any nutrient with a “high” health claim attached to it. Other health claims have their own minimum and maximum restrictions for their claims.

Application Process

To become certified to manufacture or distribute your supplements, you must complete the application process. For those not needing clarifying information, the process of applying is fairly simple and quick. The additional document section of the application process is the ideal place to upload facility inspections along with any not clearly defined substances or ingredients. Make sure before applying that all the documents are in order including following the labeling guidelines. The sooner you can apply and be approved, the sooner you can start making money on selling your supplements.

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