Quality Smart Solutions ensures your labels meet DSHEA and 21 CFR codes of federal regulations. We review your labels, advise on structure-function claims, prepare a substantiation dossier (if required), and file a premarket notification with the FDA. We guide your products to market and help you stay compliant with the FDA Dietary Supplement Regulations.
Dietary supplements are health and wellness products that contain dietary ingredients, including minerals, vitamins, herbs, amino acids, botanicals, and other categories of ingredients that can be used to supplement diets. The forms of dietary supplements include but are not limited to tablets, powders, capsules, gummies, and liquids. The supplements are used to improve health, used for the prevention of ailments, and for the maintenance of overall wellness.
Based on the CRN Consumer Survey on Dietary Supplements conducted in 2019, 77% of Americans consume dietary supplements. The majority of both are males and females, aged 18+ years. Among the age groups, adults between the ages of 35 – 54 years old share 18% consumption, the highest usage of dietary supplements. Consequently, the nutritional supplement industry is witnessing massive growth, primarily in vitamins and protein supplements.
The FDA governs dietary supplements in the USA. FTC governs the marketing and advertisement of dietary supplements. Failure to comply with the dietary supplement regulations can result in an FDA warning letter, FTC fines, stop sale, recall, and potential litigation. If you export dietary supplements to the United States it may result in entry refusal and the U.S. Customs and Border Protection Agency detaining your goods. As a manufacturer, importer, or distributor of dietary supplements and dietary ingredients, you’re solely responsible for assessing the safety and labeling of your products. You must ensure products adhere to all the requirements of FDA and DSHEA regulations. Here is a list of requirements to keep in mind for your dietary supplement.
You must follow the labeling requirements, such as nutrition labeling, ingredient labeling, and nutrient content, health claims, dietary supplement packaging regulations, etc.
Having a ‘Supplement Facts Panel’ is mandatory for every dietary supplement to be marketed in the USA. The panel must have all information required by FDA.
According to the Federal Food, Drug, and Cosmetic Act, the FDA must be notified within 30 days of your dietary supplement first being marketed in the USA.
The FDA and FTC require health claims about the safety of your dietary supplements that must be supported with reliable scientific evidence.
We have reviewed a wide range of Dietary Supplement Product Labels, including but not limited to the following.
Our team consists of professionals who have extensive experience with dietary supplement label reviews, preparation of health claim substantiation dossiers, supplement facts panel creation and filing 30 day dietary supplement notifications with the FDA
Our US regulatory specialists will review your label, Supplement Facts Panel (SFP), Structure-function claims, and give suggestions to meet labeling requirements and ensure SFP is in the correct format
Our officers will assist you in creating Supplement Facts Panel with adequate attention to the box, font, thickness, etc., and ensure it strictly adheres to the required format and remain print-ready.
We will empower you to prepare dossiers for supporting the efficacy and safety of your dietary ingredients according to the standards of evidence as described in the Federal Act.
Do not worry about structure-function claim notification as our specialists will assist you in preparing the structure-function claim notification and submitting it through mail or electronically.
Our US Regulatory experts will help you register or renew your food or dietary supplement facility with FDA. We make the entire registration and renewal process simple and cost-effective
We cater to all criteria required to serve as a US agent. With expert knowledge and extensive experience, we can answer every question the FDA may have in case of an emergency.
As per FSMA regulations a qualified individual must who is a US representative who ensures the manufacturer follows and practices cGMP. A comprehensive FSVP plan is in place to ensure import requirements are met.
If you are shipping dietary supplements into the United States a Prior Notice must be filed before arrival. An FDA confirmation with a bar code must accompany most dietary supplements at the port of entry.
We determine if your ingredient is a New Dietary Ingredient, prepare a full dossier for a New Dietary Ingredient Notification, request for FDA pre-submission meeting, and address any questions asked by the FDA.
Proven Expertise. Companies that have put their trust in us to become FDA-compliant.
FDA regulations require that certain information appears on dietary supplement labels. Information that must be on a dietary supplement label includes:
For assistance with Dietary Supplement labelling, please reach out to our friendly staff.
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