Frequently Asked Questions

We specialize in helping customers Customize and Manufacture vitamin supplements delivered in tablet or capsule form. 

Yes, QSM can manufacture unflavored powder products in bulk, however, we do not manufacture flavored or bottled powder products at this time.

QSM offers Custom Supplement manufacturing and packaging services for your dietary supplement brands. Our Packaging services include bottling and labeling for capsule and tablet-type supplements. 

No, QSM only offers custom formula Supplement Manufacturing

500K Bulk Capsules

500K – 1 Mil Bulk Tablets (depending on the number of ingredients in the formula)

QSM aims for the highest quality of products to provide to all customers, and we achieve this by complying with all FDA regulations regarding Dietary Supplements.

Yes, you can bring the Supplement Facts panel from any other competitor or you can bring your new formula to QSM.

Yes, QSM can provide all of the documentation needed for you to sell your supplement on Amazon.

Yes, QSM encourages everyone to visit, so we can put a face to our customers and create an even better relationship.

Yes, QSM is GMP Certified, FDA Registered, and Organic Certified.

No, QSM does not offer samples for custom formula products at this time. Samples of your product will only be available at the end of the production run.

QSM determines the lead time based on the availability of ingredients and the manufacturing process involved at the time the order is placed.

QSM will provide an Order Confirmation that will include the estimated time of delivery, Product Specifications that include all of the details of the order, the Supplement Facts needed for labeling, and the Certificate of Analysis for the Finished Product that includes all of the test results.

QSM will ensure that every formula is kept private by having you sign our Non-Disclosure Agreement (NDA) prior to sharing any formulas with us. 

No, but we can refer you to a contractor that has a background in dietary supplements that can assist with designing your label at a reasonable price.

Yes, QSM can print the product label for you and the pricing will be included in the quote.

No, QSM does not assist with arranging international shipping. We will help assist your shipping broker to get the product out the door. Please confirm the required paperwork for your country prior to placing your order. Each country’s requirement for imports is different.

Good Manufacturing Practices (cGMP) FDA Title 21 CFR Part 111 USDA Organic Regulations,7 CFR Part 205.

Dietary Supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients; a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for human consumption to supplement the diet by increasing the total dietary intake, a concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above. (21 U.S.C. 321)

QSM follows FDA regulations and guidelines that are set in place to dictate how Dietary Supplements are labeled and ensure the correct information is being given to consumers of the Dietary Supplements.

a) The statement of identity (name of the Dietary Supplement)

b) The net quantity of the contents statement (amount of the Dietary Supplement)

c) The Nutrition Labeling

d) The Ingredients List e) The name and place of business of the manufacturer, packer, or distributor. (21 CFR 101.3(a), 21 CFR 101.105(a), 21 CFR 101.36, 21 CFR 101.4(a)(1), and 21 CFR 101.5)

The Purchasing and Quality Department verify that all ingredients are approved for the use in Dietary Supplements via the certificate of analysis and other documents provided by the supplier.

Yes, all supplier or customer supplied materials received at the QSM facility must be received from a source that has been previously qualified by the QSM Quality Manager via the Supplier Qualification procedures established.

No, a best-by date is given for all Dietary Supplements unless the appropriate stability studies have been performed for the product to indicate an expiration date.

The name and quantities of Dietary Supplements ingredients present in the product, the “serving size” and the “servings per container”. (21 CFR 101.36(b))

a) A single easy-to-read type style.

b) All black or one-color type printed on a white or neutral contrasting background.

c) Upper and lowercase letters, except that you may use all uppercase lettering on small packages (small packages having a total surface area of 12 square inches or less).

d) At least one point leading and letters do not touch. (21 CFR 101.36(e))

Yes, testing of raw materials and finished product are sent to a third-party lab. The test results are generally a 7-day turnaround. The cost of testing is the responsibility of the customer.

The material microbial testing limits are determined from the guidelines given by the National Sanitation Foundation (NSF), American National Standard for Dietary Supplements (ANSI), and American Herbal Products Association (AHPA).

No, this must be done by the supplier so the agricultural process can be traced and QSM requests the documentation at the time of purchase.