Dietary supplements

Dietary supplements are regulated by FDA and subject to FDA rules such as facility registration, GMP & labeling requirements, and claim restrictions.

What is a Dietary Supplement?

A dietary supplement is a product intended for ingestion that is intended to supplement consumers’ diets through the inclusion of vitamins and minerals; herbs and other botanicals; amino acids; enzymes and probiotics; and concentrates, metabolites, constituents, extracts, or the combinations of any dietary ingredient from the preceding categories.

Dietary supplements

What Rules Must Dietary Supplements Follow?

Facilities that manufacture, process, pack, or hold dietary supplements or dietary ingredients for consumption in the US must register with FDA before beginning operations. To ensure GMPs are followed, FDA conducts routine inspections, monitors the marketplace, examines imported supplements and ingredients for identity, purity, quality, composition, and reviews new dietary ingredient notifications.

Dietary supplements

Why Choose TAG as Your Dietary Supplement Safety Consultant?

The expansion of TAG’s extensive experience and expertise from food and beverage to dietary supplements means we can help your business ensure the safety of your products and the regulatory compliance of your operations – from manufacturing to marketing. TAG can provide consulting services whether your products come in the form of pills, tablets, capsules, gummies, softgels, liquids, or powders.

What We Offer

Having experience with both large and small dietary supplement manufacturers, TAG has the expertise to work with you to ensure that the dietary supplements you manufacture or distribute are not adulterated, misbranded, or otherwise in violation of federal law.

TAG helps businesses:

File for FDA facility registration or New Dietary Ingredient notification
Understand & comply with labeling requirements
Adhere to nomenclature for unique ingredients
Safely use structure/function claims
Review marketing and social media claims
Liaise with government officials
Respond to regulatory notifications and warning letters (FDA, FTC, Health Canada, etc.)

TAG is the go-to consultancy firm for dietary supplement businesses. Our experience can help you ensure the safety of your products and compliance with regulatory requirements to help you keep your business running effectively and successfully.

We understand your business and what it takes to be successful.