Episode 1: Introduction to Dietary Supplement Manufacturing

We want to start with some background on the difficult issues that surround dietary supplements and the big picture regulatory requirements in managing a properly functioning dietary supplement program.

Definition of a Dietary Supplement

According to the FDA, “A dietary supplement is a product intended for ingestion that, among other requirements, contains a “dietary ingredient” intended to supplement the diet”. Dietary supplements are edible or drinkable products that provide specific nutrients including minerals, vitamins or other active ingredients to the consumer.

Like a drug, these active ingredients must be present in a specified quantity that meets FDA standards for accuracy and safety. Similar to a food, all other ingredients found in the product must be also listed for the customer.

Dietary Supplements are not Drugs

Dietary Supplement regulations in the United States are complex and somewhat controversial. The primary aspect that makes dietary supplements regulations difficult to manage for both manufacturers and regulators is that many of these vitamins, minerals, and plant or animal derived substances have purported traditional medicinal, spiritual or healing properties, but a dietary supplement is not a medicine.

The Dietary Supplement Health and Education Act (DSHEA) considers dietary supplements to be foods, unless the product can be defined as a drug.

Dietary Supplement Advertising and Labeling

Because dietary supplements are not medicine or drugs, none of these potential medical benefits are allowed to be advertised on any dietary supplement.

Where claims connecting dietary supplements with medicinal properties are made on product packaging, websites, or other marketing materials, regulators will act quickly to remove those products from the marketplace, which can be costly and disruptive to dietary supplement businesses.

If you have started, or are considering beginning production of dietary supplements, we very strongly recommend that a regulatory review of the labels and advertisement be conducted prior to your first sale.

Free Manufacturing Master Record Checklist Download

If you would like to discuss having Kellerman Consulting write and implement your food safety and quality management system program, contact us for a free consultation.