The Most Recent Dietary Supplement Regulation Is The DSHEA

In the past, dietary supplement regulation was done by the FDA exactly how they would regulate a food. These regulations were to ensure the safety and wholesomeness of the product and that misleading labeling was corrected. The Food and Drug Administration evaluated the safety of each new ingredient introduced, including anything found in a dietary supplement, as instructed in the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). That has now changed.

At this time, the country is bound by a new act. Signed in 1994 by President Clinton, the Dietary Supplement Health and Education Act of 1994 (DSHEA) became the guidelines for dietary supplement regulation. This amendment to the FD&C Act includes several provisions specifically focused on dietary supplement regulation. These changes have allowed dietary supplements to be put on the market without the pre-market safety evaluations that are required of food ingredients, whether they are new food ingredients or old ones being used in a new way.

They are required to meet other safety provisions, though. The specific provisions of the DSHEA are as follows:

Definition of dietary supplement

As found on the FDA’s website with an overview of the dietary supplement regulation (DSHEA)

A dietary supplement is:

1 a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

a. a vitamin

b. a mineral

c. an herb or other botanical

d. an amino acid

e. a dietary substance for use by man to supplement the diet by increasing the total daily intake.

f. or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.

2 intended for ingestion in pill, capsule, tablet or liquid form.

3 not represented for use as a conventional food or as the sole item of a meal or diet.

4 labeled as a “dietary supplement”.

5 a product such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).”

Safety

Within the DSHEA, an amendment to the adulteration provision of the FD&C can be found. It states that dietary supplements can be considered adulterated if the ingredients included present “a significant or unreasonable risk of illness or injury” when it is used based on labeling instructions. When a new ingredient is found in a dietary supplement, it may also be considered adulterated if adequate information cannot be provided that shows that it has no unreasonable risks of illness or injury. The Secretary of HHS is also permitted to declare a dietary supplement or new dietary ingredient poses a threat to public health and safety.

Literature

The DSHEA states that “third-party” materials, like articles, book chapters, scientific abstracts, and other publications, may be made available by retail outlets of dietary supplements.

These documents:

1 cannot be false or misleading.

2 cannot be used to promote a particular brand of dietary supplements.

3 should be displayed with other materials.

4 should be displayed away from the dietary supplements.

5 cannot have other information, like product promotions, attached.

Nutritional support statements

The DSHEA allows manufacturers to place support statements on labels of their dietary supplements, but the dietary supplement regulation is in place preventing them from claiming to diagnose, prevent, mitigate, treat or cure a specific disease. So, the label cannot state “cures cancer”. Appropriate health benefit claims that have been substantiated can be placed on dietary supplement labels, along with the statement, “This statement has not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure, or prevent any disease.” Nutritional support statements do not have to be approved by the FDA before they are placed on a label, but the FDA does need to be notified when a statement has been placed on a label within 30 days.

Ingredient and nutrition information labeling

The DSHEA has a dietary supplement regulation that states a dietary supplement must bear labels listing any ingredients and the total quantity of said ingredients. It mush also state that it is a “dietary supplement”. If the product contains herbal or botanical ingredients, the label needs to state where on the plant the ingredient is derived from.

All ingredients in a dietary supplement must be listed on the label, even if they do not have any established daily consumption recommendations. If the ingredient is not found in the product in any significant amount, it need not be listed.

New dietary ingredients

If a dietary supplement is marketed in the United States with a new dietary ingredient, it must be an ingredient that has been present in the food supply and has a history of use. The FDA must be notified 75 days before a manufacturer markets a product using a new dietary ingredient. To be approved, the supplement must be determined that it “will reasonably be expected to be safe”.

Good manufacturing practices

(GMPs)

The FDA is granted the authority through the DSHEA to create GMP regulations that will govern preparation, packing, and holding of dietary supplements so that safety will be assured. Public comment sometimes helps develop GMPs.

Commission on dietary supplements.

A committee must be formed, as a stipulation of the DSHEA, to “conduct a study and make recommendations on the regulation of label claims and statements for dietary supplements and procedures for the evaluation of the claims”. This commission will be made up of 7 members appointed by the president.

For complete details for the dietary supplement regulation DSHEA, visit the FDA website. You can also view the (TGA) Australian Therapeutic Goods Administrations dietary supplement regulation, which provides information concerning those who reside in Australia.

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