How to create your own nutritional supplement line
How much does it cost to manufacture custom formulations?
Custom manufactured supplements is our specialty.
We are a manufacturing facility and we supply nutritional supplement companies with their own line of custom manufactured supplements and private label products in their own formulas. Having your own products it also means that you decide what is the right value and the right consumer price.
Obviously, creating your own formulas has it’s unique cost price. It requires a minimum production run, and because prices fluctuate wildly for raw ingredients, it’s impossible to know exactly what your costs will be. Let us work up the price for you. We work with our clients to achieve their desired price target. It is important for us as it is for you that you are happy with your products.
As we do not sell directly to consumers, you enjoy manufacturing prices for high quality supplement products.
How do I pay for my custom formulated products?
Payment terms are included in the written proposal.
As part of our proposal, we don’t just offer a price proposal. We also offer to work with you in producing your desired formulations and as part of it, discuss payment terms.
It is important for us to be clear up front about the cost of the project and what form(s) of payment we can agree on. As customary, we will include payment due dates. Also, deadlines for the deposit, final payment, guarantees, royalties, etc. While many invoices state that payment is “due upon receipt of invoice” and/or “within 30 days of receipt,” we can also agree on a specific date.
It is important that it is communicated that the projected cost are based on information we have on hand. Or provided by you, and the final amount is subject to change if anything alters the project requirements.
Do I have to pay an initial deposit?
There is an initial deposit for your custom formulations and private label projects.
Initial deposit is customary. Contract law states that something of value has to pass between two parties before a contract can be considered valid.
We are developing and producing your own custom formulas. These formulas will be proprietary to you and you will have ownership of them. Therefore, we are requiring a deposit before we start your project. This is industry standard. The company is investing raw ingredients and man hours of our scientist to work on and develop the formula that you are looking for before we can commercially produce it.
After the deposit payment cleared the bank the project officially starts on the clock.
Custom production complete, shipping & delivery – what do I do next?
Before shipping & delivery, you get the final invoice.
We receive the prof of payment and the products are readied for shipping & delivery to you.
In order to import the goods, you will receive the Original documents necessary for US Customs, FDA clearance and for your records. Also, you will receive a copy of the Test Certificates for your product batches and also for your records. These documents are used to provide prof of purchase and ownership of the goods.
We will assist you in guiding you in ensuring that you do get established with the FDA. We will also assist you in guiding you in establishing an account with a Freight company.
What do I need to do to ensure I receive my custom formulation supplements?
Importing shipments of supplements, vitamins requires two steps to be done during the production time.
In importing shipments that contain dietary supplements it is necessary that you the importing company has contracted an agent who will assist in the importing process. Therefore, the two main steps which needs to get done are:
a) The FDA listing requirements are done concurrent with the production. We will advise and give you guidance on how to get it done.
b) A Freight Forwarding account is established who is the Agent representing you in the importing process. We will assist you in acquiring an account from a Freight Forwarding company with expertise in importing FDA listed products. When the product shipment arrives to a US Port of Entry, the Freight Forwarding company will submit all the necessary documentation to US Customs Authorities for Customs Duty payment and to the FDA.
FDA Certificate of Registration, how exactly do I acquire it?
CustomNutra works with Registrar Corp in achieving all of our clients compliance with the FDA Certificate of Registration.
The U.S. Bioterrorism Act requires any facility that manufactures of supplements that may be consumed by humans or animals in the U.S. to be registered with the U.S. Food and Drug Administration (“FDA”). Registrar Corp will properly register your facility or facilities with FDA and issue the FDA Certificate of Registration.
First of all, along with your registration, you will also receive a number of additional benefits:
• Certificate of Registration Issued by Registrar Corp: Provides confirmation of your facility’s registration to industry
• Registration Updates: Registrations must be updated within 60 days of a change in required information Prior Notice: Three free Prior Notice filings each year for products you may import
• Detention Assistance: Communication with FDA on your behalf to seek the release of a detained shipment
• DUNS Assistance: Obtain a DUNS number or update an existing DUNS record
• FDA Compliance Monitoring-We monitor your facility for FDA Inspections, Warning Letters, Import Alerts and Refusals, and alert you if there is any change published by FDA at no cost.
Furthermore, facility registration within 24 business hours and provide your Certificate of Registration within 72 business hours.
In addition to the requirement to register your food facility, the Food Safety Modernization Act of 2011 (“FSMA”) introduced additional food safety requirements for food facilities. Under FSMA, food facilities are required to write and implement Food Safety Plans. Many facilities have food safety programs such as HACCP, ISO 22000, or BRC. Writing and implementing a FDA Food Safety Plan is a new and different requirement.
Consequently, Registrar Corp can assist you with other FDA requirements. Therefore, could be and not limited to supplement labeling, prior notice, detentions, HAACP, and Mock FDA Inspections.
Do you have FDA Establishment Registration for your company?
Establishment certifications are required by law and required by regulatory agencies.
Our own Establishment Certifications are available upon request. Therefore and by law with certain exemptions, any establishment engaged in the manufacture, repacking, or relabeling dietary supplement products for commercial distribution is required to register with FDA.
In addition the FDA Establishment Registration is required within 5 days of introducing product into commercial distribution.
All registered establishments must list all of the products they produce for commercial distribution under their own labeler code. Therefore this also includes API manufacturers, other bulk manufacturers, contract manufacturers, repackers, and relabelers.
Our production Establishment is registered and it is audited regularly by the US FDA.
Are there specific FDA regulations on supplements?
FDA regulations on vitamins and dietary supplements?
Raw ingredients, vitamins and dietary supplements fall under FDA regulations, under the Dietary Supplement Health and Education Act (DSHEA) 1994. New ingredients (post 1994) to be added into dietary supplements need to go through the New Dietary Ingredient Notification (NDIN) process.
Dietary supplements include products such as vitamins and minerals, herbal products, amino acids and enzyme supplements. Albeit having requirements on labels and product safety, FDA relies more on post-market surveillance for dietary supplements, unless the product contains non GRAS (Generally Recognized as Safe) substances or new ingredients. FDA generally begins regulation after supplement products enter the market.
There are three categories of claims for dietary supplements in the U.S.:
(a) nutrient content claims with terms such as “high”, “free” and “reduced” indicating the level of key nutrients;
(b) structure/function claims describing the effect of a dietary supplement on the structure and function of body. It cannot imply any effects of the dietary ingredient on disease or condition.
(c) health claims, which needs approval from FDA describing a relationship between an ingredient and a disease or health-related condition.
Facing growing regulatory needs from the dietary supplement industry that has more than quadrupled in the last two decades, FDA announced in December 2015 the creation of the new Office of Dietary Supplement Programs (ODSP), previously a division under Office of Nutrition Labeling and Dietary Supplements.
Do you offer marketing resources to your distributors?
Marketing resources to guarantee your custom formulation success.
We offer marketing resources in terms of product knowledge for CustomNutra distributors.
Upon request, we can assist you in acquiring full Marketing Services. This is a service we offer for our clients which is a separate service agreement. As a result, it is in collaboration with our partners and it is not part of the Custom Formulation product agreement.
Marketing involves everything you do to get potential customers and to sell your product. The more you succeed, the more we succeed. With that, there are more individuals benefiting from high quality custom label formulated vitamins and dietary supplements. It is a win-win situation for everyone.
In addition, we are assisting our customers with product knowledge. Also, will also be guaranteeing that your product labels are also according to the FDA requirements. As a result, it will be making the product compliant for bringing a dietary supplement to market.
How long will it take for me to get my order?
How long will my project time be?
Project time for custom formulation, private label products is unique and therefore it depends on a number of factors that can add time into the project such as :
-do you have a product formula ready for production?
-do you have on hand art work files and logo for your private label?
-does your product requires special packaging which requires molds to be produced, etc?
-does your formula contain ingredients which are not in our list of stock ingredients and requires special sourcing and handling?
Therefore, the general rule is that as soon as we have on hand the necessary ingredients and custom packaging materials we can have your product ready within weeks. In conclusion, an estimated time frame is confirmed as the time of the proposal.
Could I see a sample of my label and packaging before it is bulk produced?
Private-label packaging is our specialty.
Private-label packaging it means that your company logo, product art work, the labels, your product packaging and product specific bar-coding are produced after agreement, specifications and current regulation. An initial sample is sent to you for your approval.
After sign off on each individual item the bulk production of all of your private label nutritional supplements can begin.
a) First of all, all individual formulas are agreed upon. Therefore, the private-label supplement facts panel sheets, sent to you for approval and after sign off on them the bulk production of the products can begin
b) The art work for labeling and packaging is produced with identification bar coding all after specification. The samples are then sent to you – you approve and sign off on them and bulk production can begin
Are supplement packets available in recyclable bulk packaging?
All supplement packets are also available in larger multi-serving containers.
Supplement packets contain a custom formulation product which is formulated to effervesce (fizz). This only happens when mixed with water. These specially formulated supplements are either in larger multi-serving container or in daily doses of supplement packets. The multi-serving container products are a slightly different formulas. It is not possible to provide that same effervescent formulation in a multi-serving container. Products in multi-serving container don’t fizz on contact with water. This is due to the moisture from the air negatively affecting the product packaged in the multi-serving container.
These formulations offer specific support for nutritional needs. The supplements deliver essential nutrients supporting your specific health and wellness goals. The multi-serving container was designed with the environment in mind and the 30 packet carton was designed for convenience and on-the-go use.
We will work with you in designing your custom formulations and we will give you professional guidance. However, the final choice is yours. You have the choice of a larger multi-serving container if it is possible.
What is your procedure for designing the custom formulation, private label artwork?
This is the procedure for designing the custom formulation, private label artwork:
- For custom formulation projects, CustomNutra will provide you with templates specific for your product label and custom design-
- You create your own label based on these templates –
- If you already have your existing label, just send us the source files for those labels. We provide you with a link to upload the files –
- CustomNutra team will provide you with a hard copy of the label sample in 7-15 days. It is sent by FedEx to you for approval
- After you have received the artwork sample and approved the sample, you sign off on it and we keep that as the master file of each labels
- At this point we can begin mass production printing.
What happens after I confirm that I want to go ahead with your product proposal?
Custom formulation project success for you and for your company is our goal.
A custom formulation project proposal is the core document. It helps you understand and for us to outline what has to happen. The project proposal is unique to each project. The format is basically the same, and we follow a basic outline.
Therefore, we will give you the answer to: What’s the problem you’re trying to solve?
Also, the answer to the question: What is the time-frame, what are the deadlines and how do you plan to meet them?
After we receive the written confirmation, a projected launch date is set. Next we roll out the steps of the project. A project manager is assigned to your project and he will be your point of contact. We will work closely with you as it is necessary to get your approval at several different stages of the production process.
We will outline what has to happen to get your products into your warehouse and ready for distribution and of course listed with the FDA.
Can you tell me exactly, what is your sales process?
Here is our transparent sales process, step by step:
- After learning about your company and your product goals you will receive a quote within 24 hours
- After your confirmation, a projected is created and a launch date is set
- Contract for the Sale of Goods is presented, deposit is made
- After the payment cleared the project steps are activated
- You will get an overview of the raw ingredients, packaging, labeling requirements
a) First of all, all individual formulas are agreed upon. Therefore, the supplement facts panel sheets, sent to you for approval and after sign off on them the bulk production of the products can begin
b) Furthermore, art work, labeling, packaging and bar coding after specification gets produced. Also, samples sent to you – you approve and sign off on them and bulk production can begin
c) Consequently, testing is done. In addition, the documents are sent to you for your records.
- As a result, the production schedule is confirmed.
- FDA registration requirements and filing requirements are done
- Freight Forwarding account is established and activated
- Production is done and final Invoice is issued for payment
- After payment cleared the products are shipped to you with all the documents necessary for the US Customs and for your records
Can I hire a professional third-party to perform inspection on my behalf?
Absolutely! You can hire and send a third-party inspector to our facility.
By sending third-party skilled professionals to our facility with your product requirements and criteria in hand, you can receive a timely and detailed report of your goods next to all of our facility production updates.
Few problems are more frustrating than those that affect product quality. And when it comes to reassurance and peace of mind, some importers opt to hire a product inspector to check the quality and status of orders before they ship.
There are some real advantages if you deem it necessary to have your shipment inspected. The main concerns are that there are integrity risks present in almost every supplement suppliers manufacturing scenario. Including product inspection, logistics and other aspects of supply chain management.
In addition, we will make every effort to assist your hired inspector.
MSG-free custom formulation supplements?
All of our products are MSG-free.
We require proof from all of our suppliers that their raw material is MSG-free. We do not accept raw materials that contain MSG. CustomNutra does not add MSG to any of our products during the private label manufacturing process.
What Is MSG?
MSG occurs naturally in ingredients such as hydrolyzed vegetable protein, autolyzed yeast, hydrolyzed yeast, yeast extract, soy extracts, and protein isolate, as well as in tomatoes and cheeses. FDA requires that these products be listed on the ingredient panel. The agency does not require the label to also specify that they naturally contain MSG. Foods with any ingredient that naturally contains MSG cannot claim “No MSG” or “No added MSG” on their packaging. MSG also cannot be listed as “spices and flavoring.”
Is there sugar, fructose or high fructose corn syrup in CustomNutra products?
No, NEVER any fructose or high fructose corn syrup.
We purposely avoid using fructose or high fructose corn syrup in our products because of the health concerns associated with fructose consumption.
You will notice that some of the leading supplement brands ignore this important point. They include fructose in their products—but not CustomNutra.
Table sugar which is sucrose, from sugar cane or sugar beets is made up of fructose and glucose. High-fructose corn syrup (HFCS), on the other hand, is derived from cornstarch, which consists of a chain of only glucose molecules.
High-fructose corn syrup is a common sweetener in sodas and fruit-flavored drinks. In addition, research has shown that high-fructose corn syrup is chemically similar to table sugar. Controversy exists, however, about whether the body handles high-fructose corn syrup differently than table sugar.
Regarding sugar, check the label on each product for that answer. However, we do everything we can to NOT add any sugar to our supplements. If a sweetener is necessary, we prefer to use natural sweeteners such as stevia and Monk Fruit (Luo Han Go).
Is it safe combining supplements?
Before combining supplements, people should consult a health care practitioner.
Dietary supplements vary in the nutrients they provide, as well as in the dosage of included nutrients. In combining supplements, it is important to check that the daily amount taken of each particular nutrient does not exceed safe levels.
Certain supplements may interact with each other. There is competition within the gut for the absorption of different minerals. A large dose of one mineral might decrease the absorption of another. Therefore a multivitamin and/or mineral product is best for all-round supplementation. This is because they are designed to deliver nutrients in the right balance.
Opt to take multivitamins. It is recommended choosing one that provides no more than 100 percent of the daily value of each nutrient.
If your doctor prescribes a dosage higher than the daily value of a particular nutrient, disclose any other vitamin and herbal supplements that you take so that problematic combinations can be avoided.
Do CustomNutra supplements contain any aspartame or artificial sweeteners?
No artificial sweeteners. CustomNutra only uses natural sweeteners.
The majority of sugar substitutes, artificial sweeteners approved for food use are artificially synthesized compounds.
Furthermore, artificial sweeteners are regulated by the U.S. Food and Drug Administration (FDA). The FDA has only approved six artificial-sweeteners for use in the products we buy: Saccharin, Acesulfame, Aspartame, Neotame, Advantame and Sucralose. Especially relevant, some of these substitutes claim to be safe, during their production they are still processed and refined. We all respond differently to each of these sweeteners and they have a complex effect on your body and brain. In conclusion, all of these will have the same negative impact.
Natural sweeteners can be used effectively in moderation to provide the sweetness that most people crave. Every living creature is designed to run off of a simple sugar called glucose.
Custom formulation nutraceuticals, are these products tested at all?
Private label nutraceuticals manufactured in our facilities are tested by an independent third party accredited testing facility SGS.
Yes, every batch of private label nutraceuticals that are manufactured by CustomNutra have random samples tested by an independent third party testing facility, SGS. Although this third-party is free to do any test they chose to run, the three most common tests are a test for heavy metals, a toxin test and a microbial test. The entire batch is destroyed in the event that a product fails even one test.
Private label nutraceuticals and custom formulations produced at our facilities are tested during and at the end of each production. Documentation is available upon request which is proprietary to your products.
Furthermore, our in house labs performs testing per product and by production batch. SGS performs final production test on each batch produced.
In addition, the on site lab tests all raw ingredients used before any kind of production. Therefore, specific type of testing may take place during the production process as needed.
As a contract vitamin manufacturer we assume full responsibility. Our QC department approves and releases products to market for our wholesale vitamin suppliers and our supplement companies. The approval is based on our stringent quality standards.
Can I take your supplements while pregnant or nursing?
Pregnant or nursing mothers should consult a health professional before using any supplements.
Pregnant or nursing mothers have more intense nutritional needs than pregnant mothers. During pregnancy, mothers need to consume enough nutrients. This is to meet their increased needs as well as those of their growing baby.
Take the supplement your doctor recommends. Follow his or her advice about taking any other supplements or herbal products.
Nursing is an extremely nutrient-intensive job. For healthy breast milk and adequate breast milk production, it’s important to meet your body’s nutritional needs.
Doctors often recommend that women who are breastfeeding also continue taking prenatal vitamins after delivery. Tell your doctor about any supplements you are already taking. Including, herbal or botanicals as to protect yourself against taking too much. Scientists have not determined the possible risks for your baby of taking most herbal or botanical supplements. Prenatal vitamins can serve as a further supplement to lactating women who need plenty of nutrients to make breast milk.
Also, tell your doctor about any other medicines you are taking to see if there could be interactions of your supplement with these medicines.
Can I mix supplements with my medications?
Please consult with your health professional the question of taking supplements with medications.
Taking supplements with medications, depending on the medication involved, the results can be serious.
Follow the instructions on each product label. If using water, most people prefer to put the water into a cup first. Then, pour the powder supplements into the cup and mix.
Remember to mix your powder product with water. If not, the label on the CustomNutra product will no longer represent exactly what you are consuming. This is because you will be adding other things.
If you mix the CustomNutra powder product with juice, you will be consuming a significant amount of SUGAR from the juice. This is along with the nutrients in the CustomNutra supplements.
When you take prescription or over-the-counter (OTC) medications, do you take also a vitamin, mineral, or other dietary supplements?
Have you considered whether there is any danger in mixing medications and dietary supplements?
Therefore, it could be, says Robert Mozersky, a medical officer at the Food and Drug Administration (FDA). “Some dietary supplements may increase the effect of your medication. Other dietary supplements, may decrease it,” he says.
Certain dietary supplements can change absorption, metabolism, or excretion of a medication and therefore affect its potency. “You may be getting either too much or too little of a medication you need,” Mozersky warns.
“The bottom line is, before you take any dietary supplement or medication—over-the-counter or prescription—discuss it with your health care professional,” Mozersky says. Remember these tips:
- Every time you visit a health care professional’s office, bring a list of all the dietary supplements and medications you are currently taking. Include the dosages and how many times a day you take them. Some people find it easiest to throw all their dietary supplements and medications in a bag to bring to the medical visit.
- If you’re thinking of adding a dietary supplement to your daily routine, call your health care professional first, and let him or her know what other supplements and medications you’re taking.
- Also tell your health care professional if your health status has changed, particularly if you are pregnant, breastfeeding, or have had any recent illnesses or surgery.
Can I drive after taking Vitamin Zzzz with melatonin?
No, you should not drive or operate heavy machinery after taking melatonin.
This supplement contains many ingredients each which influence a different part of the sleep/wake cycle to ensure that you can fall asleep naturally, and experience a restful sleep. This product contains just a hint of melatonin which naturally promotes sleep.
This hormon plays a role in your natural sleep-wake cycle. Natural levels of this hormone in the blood are highest at night. Some research suggests that melatonin hormon supplements might be helpful in treating sleep disorders, such as delayed sleep phase, and providing some relief from insomnia and jet lag.
This hormon is generally safe for short-term use. Unlike with many sleep medications, with melatonin you are unlikely to become dependent, have a diminished response after repeated use (habituation), or experience a hangover effect. However, due to the increased subjective sleepiness after administration of this hormone, caution should be exercised when under the influence of this hormone.
It would be unusual to take Vitamin Zzzz more than once per day. If you feel you need to take it for more than seven consecutive days, check with your health care provider.
If you’re considering taking melanin-hormone supplements, check with your doctor first — especially if you have any health conditions. He or she can help you determine if it is right for you.
Can children take vitamins and dietary supplements?
Always consult your pediatrician before giving children’s vitamins and dietary supplements to your child.
Children’s vitamins and dietary supplements are important elements of the total nutritional requirements of your child.
A multivitamin or dietary supplement cannot replace a healthy diet. It can only fill in nutritional gaps. Because the human body itself is unable to produce adequate amounts of many vitamins, they must be obtained from the diet with the minerals. Not all children eat a balanced diet. These deficiencies can interfere with their growth and development. The body needs these vitamins and dietary supplements in only tiny amounts, and in a balanced diet they are usually present in sufficient quantities.
Thus, as a young adult, supplements are rarely needed. Some kids eat a diet that restricts particular foods due to food allergies. Some eat a vegetarian diet. Children that eat diets that lack certain foods may be at greater risk for nutritional deficiencies. Not all vitamins are created equal, so it’s important to know what you are getting when selecting a vitamin.
CustomNutra products are formulated for adults and they are a custom supplement formulation for adults.
Are your products Non-GMO?
We choose to source only from suppliers that provide raw materials that do not contain GENETICALLY MODIFIED ORGANISMs. Also, we do not source from suppliers that provide blends partially containing GENETICALLY ENGINEERED INGREDIENTS. We require verifiable proof of Non-GMO certification before we even consider doing business with a supplier.
Studies by leading industry research groups consistently show that consumers not only want to avoid GMOs in their supplements, but also actively seek out GMO free claims. Key reasons, half or more of natural shoppers say they buy non-GMO. The main concerns are about safety, increased availability where they shop, becoming more aware of the GMO issue. One in five consumers surveyed actively consider the Non-GMO mark to avoid consumption of GMOs. 50% of people surveyed in North America try to avoid GMOs in the food they are consuming. 72% say that it is important to avoid GMOs when shopping, and 40% are looking for GMO free claims on labels. 92% of American consumers think GMO supplement and all foods should be labeled as such.
Are your products gluten free?
All of our products are gluten-free.
We require proof from all of our suppliers that their raw material is gluten-free. CustomNutra does not use gluten during the manufacturing process of our products.
What Is Gluten?
Gluten is a mixture of proteins that occur naturally in wheat, rye, barley and crossbreeds of these grains. It helps foods maintain their shape, acting as a glue that holds food together. A gluten free diet is essential for managing signs and symptoms of celiac disease and other medical conditions associated with gluten. A gluten free diet is, however, popular among people without gluten–related medical conditions.
In August 2013, the Food and Drug Administration issued a final rule that defined what characteristics a food has to have to bear a label that proclaims it “gluten–
Are there any artificial dyes in CustomNutra products?
No artificial dyes are used in our production.
CustomNutra supplements contain only natural ingredients and no artificial dyes.
Artificial dyes are being added to our foods, skin products, bath products, etc. at an alarming rate. Somehow the rate is increasing even though studies are linking these dyes to a number of disorders. Everything from cancer to hyperactivity in children. The risks can be deadly, and the benefits: a more appealing product to draw consumers in, to make a sale.
Under the Federal Food, Drug, and Cosmetic Act,all color additives and new uses for listed color additives must be approved by the FDA. This has to be done before they may be used in foods. The FDA requires food manufacturers to list all ingredients on the product label. With the ingredients used in the greatest amount first, followed in descending order by those in smaller amounts. The label must list the names of any FDA-certified color additive. Synthetic color additives, also known as certified colors, are required to undergo batch certification. This is a process in which the FDA analyzes a representative sample of each batch of the color additive. This is to ensure it meets the required identity and specifications before it can be used.