Custom Formulation

High Quality Custom Formulation

Custom Formulations

What is a Custom Formulation?

Custom Formulation begins with an idea. There are thousands of different types of the same supplement, or what seems like the same supplement. So many formulas are available that you may be considering creating your own “custom version” to break through with the next ‘best thing’. That process is called “Custom Formulating”. Once the idea has been formed, you may wonder ‘now what?’. How to move forward is the hard part. To find some direction, you will need to consider the following questions:

  • Is your idea, just an idea and are you aware of the implications regarding FDA compliance, quality controls, and laboratory testing requirements? These factors should be considered to determine if your idea is even viable.
  • How will you differentiate your new product from that of the competition?
  • What is the value proposition (your secret recipe) of why is this worth the investment?
  • What form will this new supplement be consumed in? (i.e.: tablet, softgel, powder, tablet, etc.)?
  • What will a serving size look like?
  • What does the market currently look like in the same space as far as pricing is concerned?
  • How long will it take to become profitable with this new formulation?
  • How long will it take to get produced?
  • Does your current manufacturer have the ability/capability to produce it?
  • What testing will you need to confirm the claims outlined on the label or packaging of your new formulation?

Then What????

Once you know the answers it is time to get started, but how? The best solution is to contact your manufacturer of choice and ensure that they can take on your project. Ask about their quality systems, lead times, ability to produce new formulas, number of years in business, and whether or not they are FDA registered and periodically inspected.

Once you have chosen the right partner, your new supplement has begun to take form. By then you will have ensured that the right ingredients are being sourced and that testing is being done. You will also have decided on the form or type of the supplement to offer, and will have discussed turn-around times from your manufacturer. The next step, which may not seem so important at first, is elaborating the labeling and packaging. The packaging must be attractive and stand out next to the competition; if not, you risk getting lost in a wide sea of other average-looking supplements.  

High Quality Custom Formulation

Toll Manufacturing vs Contract Manufacturing

Contract manufacturing agreements

Toll Manufacturing vs
Contract Manufacturing

Though they are very similar, in practice are very different. In this article the differences will be brought to light and made to be understood. We will also talk about the similarities.

First things first though: choosing the right manufacturer to do the work is key. When choosing a manufacturer check out our post here for questions you should be asking.

Now that you know the questions you should ask when choosing a manufacturer let’s get started. Let’s begin with the literal definitions of Toll Manufacturing and Contract Manufacturing.

Toll Manufacturing – When a company provides its raw materials or semi-finished goods to a third-party service provider (The manufacturer). That provider, has a specialized infrastructure to complete the job and provides the service of manufacturing processes for the company using the materials/components for a fee.

Contract manufacturing agreements

Contract Manufacturing – When a third-party company hired to produce the goods provides the manufacturing process/service as well sources all the raw materials and packaging components. Contract manufacturing creates a supply-chain vendor for a branded, private label or custom-made product. The contract manufacturer is responsible for making the product to the client’s exact specifications and meeting the delivery time requirements.

In conclusion, the two processes are very similar, but their differences are substantial. Substantial because raw material sourcing is an integral part of the process affecting timely manufacturing, delivery of finished product and cost.

Which service is right for you? It all depends on how you decide to source your materials. If you want an easier “one-stop-shop” type of process, then Contract Manufacturing is the way to go. If you prefer to  source your own raw materials and/or packaging materials, then Toll Manufacturing is the answer.

What are Excipients?

excipients
excipients

What are those "Other" Ingredients (Excipients)?

You are a health-conscious person, you eat organic, exercise daily, try to get enough sleep, and you take vitamins and supplements. You read labels because you care about what goes into your body. As you are reading your vitamin and supplement labels, you may see some curious ingredients, such as Magnesium Stearate, Stearic Acid, and Cellulose. You may wonder, “What could these be? These “other ingredients” are also known as excipients. What is an excipient and why are they in my organic vitamin and supplements?

An Excipient is….

Any component other than the active ingredient(s) that is present in a dietary supplement or pharmaceutical medication. These are substances that contribute to functional and structural characteristics to various forms of dietary supplements, without necessarily delivering any significant nutritional benefit. Excipients simply make it easier to maintain the integrity of the supplement during and after production.

How??

Excipients aid in the manufacturing process, assist in product formulation, and serve as carriers, fillers and anti caking agents for the main/active ingredient(s). Excipients may also be used to enhance the finished product’s appearance, stability, and bioavailability. Protecting, supporting, and enhancing stability improves overall safety and function of your supplement.

What are some examples of Excipients and their functions?

  • Stearic Acid, Cellulose – Binding agents that help keep tablets together and add volume to capsules.
  • Silica – Anticaking agent/Moisture Absorber: Prevents foods/powders from caking or sticking together in clumps, helping them flow smoothly. This may help ensure a product’s shelf life, protect against the effects of moisture.
  • Magnesium Stearate – Flow Agent – It helps prevent supplement ingredients from clumping together and sticking during the manufacturing process.

In conclusion...

Excipients are commonly used in pre-workouts and many powdered products, as well as most capsule and tablet formulas. Excipients allow for manufacturing equipment to operate smoothly and without jamming. Excipients also help safeguard the integrity of the supplements during and after production. And, in general, excipients do not contribute any significant nutritional benefits.

Supplement Labeling – Does Anything Go?

FDA Labeling Guidelines
FDA Labeling Guidelines

Supplement Labeling – Does anything go?

We have all purchased a health supplement from the store, whether it be your daily multi-vitamin or any other supplement. You peek at the label and see a wealth of information. It all looks great, but is that all there is to the label? How did the manufacturer decide what to put on it? Are there any rules regarding what can be displayed, or can anything be listed? As it turns out, the FDA has a hand in regulating how the label is laid out and what information must be on each label.

It started with “The Nutrition Labeling and Education Act of 1990” which amended the Federal Food, Drug, and Cosmetic Act (the act) in several important ways. Most notably, by requiring that most foods, including dietary supplements, bear nutrition labeling.

There are in fact five label statements required on containers and packages of dietary supplements.

These are:

  1. The statement of identity (name of the dietary supplement).
  2. The net quantity of contents statement (amount of the dietary supplement).
  3. The nutrition labeling.
  4. The ingredient list.
  5. The name and place of business of the manufacturer, packer, or distributor.

Supplement Bottle Label

The FDA regulates both finished dietary supplement products and dietary ingredients. The DSHEA states:

“Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.”

What if my label is incorrect?

The Federal Trade Commission does have a role in the regulating Dietary Supplement Advertising, and the label of your supplement is considered a part of that. The Federal Trade Commission (FTC) has broad authority to regulate dietary supplement advertising. With overlapping jurisdiction to regulate the labeling and advertising of foods, over-the-counter drugs, medical devices and cosmetics, FDA and FTC have worked out a memorandum of understanding (MOU) pursuant to which the FTC has primary responsibility for regulating advertising and FDA for regulating labeling.

Now that you have learned the requirements of what belongs on a label, you can contact Health Genesis Corporation and our team of professional graphic designers to take the added pressure off of you.

Organic and All Natural

organic and all natural
organic and all natural

Organic and All Natural

What’s the difference between organic and natural? Isn’t “All Natural” just as safe and healthy as Organic? Unfortunately, “All Natural” is not the same thing as “Organic” and comes with no guarantees. “Natural foods” are often assumed to be foods that are minimally processed and do not contain any hormones, antibiotics, or artificial flavors. In the US, however, neither the FDA nor the USDA have not engaged in rulemaking to establish a formal definition for the term “natural”. Therefore, food manufacturers often place an “All-Natural” label on goods containing heavily processed ingredients.

Organic Rules

Let’s talk “Organic”: When a product is labeled “Organic” or “Certified Organic”, there are legal regulations that must be followed in order to place that label on the packaging. Only organic guarantees no toxic synthetic pesticides or herbicides, or chemical fertilizers that are used in production; and no antibiotics or growth hormones are given to animals. Organic producers and processors are also are subject to rigorous announced – and unannounced – accreditation inspections by third-party inspectors to ensure that they are truly producing and processing organic products

What does “USDA Organic” mean on a supplement or food Label?

When you see the USDA organic label on a bundle of bananas, for example, you can trust that the fruit was grown on organically-certified land that promotes biodiversity as to not waste natural resources. USDA Organic products are also considered Non-GMO (Non Genetically Modified).

Organic Certified

Products that have a 100% organic label only contain 100% organically produced ingredients, excipients and/or processing agents. To obtain a “Certified Organic” label approval, products must be comprised of at least 95% organically grown/produced ingredients, with an exception to salt and water.

Certain products that possess at least 70% organic certified content may be certified as “made with organic ingredients” but are not allowed to bear the USDA Organic seal. These products may list certain approved conventional ingredients alongside the organic ones.

So, there is a difference!

So, as we see, there is certainly a difference between “Organic” and “Natural”. However, this does not necessarily mean that products labeled “Natural” are not good products. It simply means that products bearing the USDA Organic seal or displaying “Made with Organic” certification, have undergone processes that rely on natural substances and physical, mechanical, or biologically based farming methods to the fullest extent possible.

Health Genesis Corporation has a full line of USDA Organic Supplements certified by EcoCert ICO and CCOF that are available for private label. We also offer certified organic raw ingredients and manufacture private label organic supplements according to the highest standards of quality and to our clients’ exact specifications.

Looking for a Contract Manufacturer?

Health Genesis Contract Manufacturing

Contract Manufacturing

Here's a checklist of questions and steps you should go through before selecting one

Are you looking at selecting a contract manufacturer for the very first time? 

There are a few things that you should ask yourself and the representative of the company that you are requesting the information from. You do not want to hire a fly-by-night company but rather one that is well established and capable of providing quality products and services for you

You don’t want to hire a fly by night company but rather one that is established and capable of providing a quality product for you.

Do they perform everything they say they do?

  • Do they perform the manufacturing themselves, or are they a middleman that farms the work out to a real manufacturer? Any certifications? Is the company FDA inspected and/or USDA Organic Certified? What other Global or National Certifications do they hold? What do these certifications mean?

Insist on a tour of their facility/building.

  • Again, are they truly a manufacturer or a middleman outsourcing the work? There are dozens of ghost companies posing as manufacturers and they are simply reselling products and services. Request a tour of their facilities; serious manufacturers will be more than happy to take you on a tour and show off their equipment, personnel and quality systems. It is something that manufacturers are normally proud of.

Is it difficult to speak to a live person?

  • The manufacturer you want to work with is one that answers the phone and responds to emails and texts promptly. If you are constantly leaving messages or being ignored by email or text, you can expect to continue to be ignored during the manufacturing process. You can also expect to be ignored when there are delays or when things might go wrong with your order. Choose a manufacturer that will always respond to phone calls, emails or texts, and one where you don’t always have to be leaving messages with a receptionist or an answering service.

References

  • Are they willing to give you references? Ask for them. Good manufacturers are proud of their work and are willing to have you speak to other happy customers who can share their experience

Check how long their company has been doing business online.

  • How long have they been in business? Check business licenses, online reviews (Remember no company has only perfect reviews), do some digging.

Do they have liability insurance with their company name on it?

  • If they do not have product liability insurance, then you do not have any coverage from them!

What other services do they offer?

  • Contract Manufacturers should be making your business easier, not more difficult. Does the manufacturer provide one-stop shop services, such as private label, contract manufacturing, toll manufacturing, co-packing, logistics, storage, inventory management, graphic/label design, label printing, FDA compliance assistance, Amazon services, among others.

At Health Genesis, we are a one-stop shop for science-based products that are backed by rigorous research. Our mission is to harness nature’s power to heal and sustain and share its bounty with our clients. Development, production, and quality are the cornerstones of what we do. Every client from the distributor to end consumer deserves the utmost in quality, consistency, and care. We take pride in making products that cover a wide scope of applications at the most competitive prices.  

At Health Genesis we exude enthusiasm. This evolves from knowing that we are helping to develop the highest quality health supplement products in the industry. Our team consists of people who are natural explorers – passionate about the healthful ingredients found in nature and are committed to finding the most pure and effective combinations that promote wellness. We thank you for your interest in working with us and always look forward to exceeding your expectations.

Health Genesis Corporation