Dietary Supplement Labeling Guide: Understanding Claims, Labels and Regulations

 

Dietary supplements are in high demand, and businesses offering or planning to offer any of the following will need to meet the strict claim, FDA label requirements for dietary supplements:

• Botanicals
• Herbs
• Minerals
• Protein bars
• Other supplements

Health and nutrition are big business, and while regulations are strict, they’re not as stringent as over-the-counter or prescription drugs. The following dietary supplement labeling guide will outline the requirements that all products deemed “dietary supplements” will need to meet to legally be sold in the United States.

Additionally, consumers can use this same information to better assess the products on store shelves and make informed, educated decisions during the purchasing process.

Claim Requirements and Regulations

Supplements in the United States are not permitted to make claims that they can:

• Cure a certain disease
• Treat a disease
• Prevent disease

However, there are other claims that can be made to help the consumer better understand the benefit that a potential supplement may offer.

Health Claims

First and foremost, the supplement can show that there’s a link between a substance or food contained in the supplement and a health condition.

For example, a calcium supplement cannot say that it cures osteoporosis. However, the supplement may mention that it can lower the risk of osteoporosis if the product contains enough calcium.

It’s important to note that there needs to be a proven link between any health claims made and ingredients in the supplement.

Structure/Function Claims

A structure or function claim refers to how the supplement affects functions or structures in the body. An example of a structure/function claim is as follows:

• Calcium helps build strong bones
• Antioxidants help neutralize free radicals

These claims relate to specific ingredients in the supplement that lead to these structure or function benefits rather than the supplement as a whole.

Nutrient Content Claims

Nutrient content claims refer to the level of a specific nutrient in a supplement. These types of claims must be accurate and cannot be exaggerated.

For example, it’s acceptable to claim a supplement with 200 mg of calcium is “high in calcium.” A supplement with 12 mg of vitamin C may be labeled as a “great source of vitamin C.”

Other Types of Claims

Supplement claims can often be outrageous, and many consumers do not realize that the following claims on supplements are not regulated by the government:

• • All-natural: The term “organic,” is regulated by federal government. However, the term “all-natural” is not and can be anything. The “all-natural” term is often used as a selling point, although there is no official definition for it.
  • Pharmaceutical strength: Similarly, the term “pharmaceutical strength” is not regulated and there is no official definition for this term. In other words, it is a term used simply for marketing purposes.

 

 

Labeling Requirements and Regulations

In the Dietary supplement labeling guide, Dietary supplements must include multiple label areas and very specific information to meet guidelines. The four main areas that must be included are:

1. 1. Daily value (DV): The daily value (DV) indicates how much of a specific mineral or vitamin is within the supplement with respect to the recommended nutritional requirement of the average individual.

 

1. 1. International unit (IU): Vitamins and other ingredients may be required to have the international unit (IU) measurement included. Vitamin D, for example, would have this unit on the label. The IU is an important form of measurement for an active substance with respect to its biological effect.

 

1. 1. MG / MCG: MG refers to a milligram or one-thousandth of a gram. MCG refers to a microgram or one-millionth of a gram. Milligram (MG) and Microgram (MCG) can both be listed for important vitamins and minerals.

 

1. Serving size: The serving size recommendation must be present on the supplement’s label and must reflect the size based on the product. One tablet or one scoop of a supplement, for example, will suffice. Alerting the consumer to maintain adequate serving sizes can reduce the risk of adverse side effects.

Labels should be reviewed prior to mass printing to ensure all required information is present.

FDA  Dietary Supplement guide and Requirements

 

Are Dietary Supplements Regulated by the U.S. Federal Government?

Yes. The Dietary Supplement Health and Education Act (DSHEA) was established in 1994 by Congress to build a regulatory framework for the labeling and safety of supplements.

Now, supplement manufacturers are also required to follow the industry’s Good Manufacturing Practices (GMPs), which include ingredient testing.

One important thing to note is that, unlike prescription and over-the-counter drugs, supplements covered by the Act do not need approval from the FDA before being marketed to the public. The primary exception here is for products that introduce new dietary ingredients, as market reviews and other information are required for safety.

Is the Advertising of Dietary Supplements Regulated by the U.S. Federal Government?

Yes. Dietary supplement advertising is regulated by the Federal Trade Commission (FTC). Promotional and advertising materials sent via mail fall under U.S. Postal Inspection Service regulations.

How Do Regulations Differ for Supplements and Drugs (Prescription and Over the Counter)

Regulations differ greatly between supplements and drugs, and that’s because supplements are labeled as food products – not drugs.

Drugs, whether prescription or over the counter, must undergo several clinical studies to measure their:

• Safety
• Effectiveness
• Interactions
• Appropriate dosages

The FDA must then review the data and authorize the use of the drug before it can even be marketed to the public.

Unlike drugs, supplements do not have to undergo testing with the FDA, nor does the FDA have to authorize the use of supplements before they are marketed.

That said, the FDA does have the authority to remove supplements from the market if it finds them to be unsafe for consumers.

What is the American National Standard for Dietary Supplements?

The NSF/ANSI 173: Dietary Supplements is the American National Standard. The Standard helps verify that the label matches the product’s contents. Testing is also conducted to check for unsafe levels of contaminants, such as pesticides, herbicides, and heavy metals.

Help with FDA label requirements for dietary supplements

If you have doubts about handling FDA label requirements for dietary supplements, Cosmereg can assist you in each step. For more information just contact us.