Keep your dietary supplement facility
compliant.
Import and market dietary supplements safely with Registrar Corp. Our team of regulatory professionals is dedicated to helping you get and maintain compliance.
Services
Registrar Corp specializes in food, beverage, and dietary supplement compliance. Our dietary supplement services include facility registration and renewal, label and ingredient review, Prior Notice submission support, and Master Manufacturing records review.
We leverage decades of combined team and industry experience to help domestic and international dietary supplement manufacturers navigate compliance. Our food compliance and safety services range from FDA and GACC facility registration to Prior Notice support.
FDA Registration
Keep your dietary supplement facility registration up to date. We offer quick and affordable facility registration, renewal, and DUNS number assistance. We can also assist with our U.S. Agent representation services and access to our MyFDA platform so you can maintain compliance easily.
Label and Ingredient Reviews
FDA requirements for dietary supplements change constantly—Registrar Corp can help you keep up. Our label and ingredient review services include in-depth reviews of your product labels, a detailed report of recommended changes, ready-to-use graphic files of compliant labels, and one-on-one guidance from our regulatory specialists.
Prior Notice
Protect public health by submitting mandatory advance notice for every imported shipment. Registrar Corp works with you to gather and provide additional documentation, meet strict submission guidelines based on your shipment’s transport method, and navigate Prior Notice submission software systems. You can also file multiple Prior Notices with our secure and efficient Prior Notice Express service.
Master Manufacturing Records
Firms manufacturing dietary supplements must write and implement Master Manufacturing Records (MMRs) for each unique formulation and batch size. MMRs identify manufacturing process steps and stages to help manage consistency in the components, quality, labeling, and packaging of each supplement batch. Our food safety specialists will review your facility’s MMRs to assure ongoing FDA compliance.
Other Services
Registrar Corp supports dietary supplements facilities with timely adverse event report forwarding by acting as your U.S. contact. We also offer detention assistance for shipments that have been delayed and held by FDA.
Get and maintain compliance with Registrar Corp.
With our industry experience and team of specialists, your dietary supplement facility is in safe hands.
Frequently Asked Questions
A product intended for ingestion that also contains a dietary ingredient intended to supplement the diet, such as vitamins, minerals, herbs or other botanicals, amino acids, enzymes, and live microbials (probiotics). They can be sold in many forms, pills, tablets, capsules, gummies, soft gels, liquids, and powders, or even types of food, such as teas or bars, as long as they are not advertised as food or a meal item.
A dietary ingredient must fall into one of the categories below:
- Vitamin
- Mineral
- Herb or botanical
- Amino acid
- Dietary substance used to supplement the diet by increasing the total dietary intake
- Concentrate, metabolite, constituent, extract, or combination of ingredients from the categories above
A new dietary ingredient is a dietary ingredient that was not marketed in the United States before October 1994.
FDA regulations require all dietary supplement labels to include a:
- Product name
- Statement that product is a dietary supplement or equivalent term that replaces “dietary” with the product dietary ingredient, such as “iron supplement” or “herbal supplement”
- Manufacturer, packer, or distributor’s name and place of business
- Supplement facts panel nutrition label
- List of other ingredients
- Net quantity of contents
- Domestic address or domestic phone number for reporting serious adverse events to the manufacturer, packer, or distributor
No. Any product sold as a dietary supplement and marketed as a treatment, prevention, or cure of a specific disease or class of diseases meets the FDA’s definition of a drug and is subject to drug regulations.