Is Your Amazon Account at Risk?

Lief Labs is here to help protect your inventory and support a safe and compliant brand. Lief goes above and beyond to make sure you are informed and your brand is successful in every possible way. Our team is ready to work with you to build a brand that is not only innovative, sustainable and marketable, but that equally adheres to cGMP (current Good Manufacturing Practice) regulations, so your inventory and Amazon account will stay protected! Get started now with Lief’s free GMP Starter Kit! This guide will help educate you by providing examples of documents, procedures and regulations that you can use on your path to cGMP compliance.

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What does it mean to be non-GMP compliant?

By being non-GMP compliant, you put your brand at the mercy of repercussions such as recalls and Amazon account shutdowns, should the FDA deem your products unsafe for consumers. Such repercussions put inventory at risk which could lead to tremendous financial losses. Additionally, brands involved in non-GMP compliant cases are left with a poor reputation, loss of customer confidence and possible criminal prosecution.

Inside the GMP Starter Kit

1

Make sure your CMO is cGMP Compliant

2

Ensure your company contributes to the safety of consumers

3

Prepare your company if there is a recall

Working with Lief

When you work with Lief, you will have access to our exclusive in-house flavor specialists. These specialists will work with you to craft the most premium custom flavors imaginable to give your products the distinction they need in a crowded market. Lief offers a complete turn-key solution for all of your contract manufacturing needs to better streamline your operations. With the highest quality certifications, a knowledgeable product development team and industry experts, Lief excels at building brands that exceed industry standards, while maintaining compliance. Working with Lief is so seamless, you will feel that we are part of your company!

10 Mistakes to Avoid when Formulating a Supplement

1.) Starting Product Development without Market Research

Before entering the product development stage, it’s critical to the formula’s success that you take the time to conduct market research. Specifically, you should identify your target demographic and audience type. This information will help establish the basis around which your formula is created and ensure it appeals to the right consumers.

2.) Formulating without Goals or Intention

Without knowing what the purpose of your supplement is, the formulation process will prove itself challenging. It’s important to have a clear understanding of the supplement’s end goal and the benefits it will provide the consumer. Decisions regarding ingredients and quantities will all stem from the intentions you set for the supplement before it is formulated.

3.) Not staying up-to-date with FDA Regulations

The FDA regulates which raw materials are banned. The last thing you want to do is complete the formulation process just to find out later down the line that a raw material used in your formula is banned. Review these regulations before finalizing a formula to ensure your supplement is in the clear. The FDA also keeps an “Advisory List” for materials that haven’t been banned but don’t appear to be lawful and should be avoided. You can find both lists here.

4.) Determining Certifications after Formulating

To avoid having to re-formulate, decide on which certifications you want your supplement to claim before entering the formulation process. Depending on the certification, there will be regulatory obligations that your formula will need to abide by.

5.) Ignoring Potencies and Label Claims

Potencies and Label Claims can get complicated. However, it’s vital to understand that most ingredients are not 100% pure. With potency testing, the concentration of active ingredients can be measured for accurate content claims.

For example, magnesium citrate is only 14% active magnesium. To hit label claim of 100mg magnesium, ~715 mg of magnesium citrate would need to be put into the formula.

6.) Not reviewing FDA Daily Value Regulations

The FDA regulates the daily values for vitamins and minerals. When you formulate a supplement designed to account for a percentage of a person’s daily value of a nutrient, it will have to coincide with what the FDA determines a person’s daily value of that nutrient is. When the FDA makes adjustments to these values, your formula will need to adjust too.

7.) Selecting Flavors that don’t compliment Formula Actives

Flavoring your supplement is one of the most exciting steps in formulating. However, problems can occur when your flavor choices don’t compliment the natural flavors that already exist in your formula’s actives. Use the natural flavors from ingredients to your advantage and choose additional flavors that will compliment them.

What to avoid (Example): Formulating a Vitamin C supplement, which has a natural citrus flavor, and choosing to flavor for a coconut taste.

8.) Forgetting to add necessary Excipients

Although excipients will not provide any beneficial value, including them in a formula can provide other values to a supplement. This includes contributing to the consumer’s experience by enhancing aesthetic, taste or form. By utilizing excipients in an effective and conscious way, you can increase the quality and performance of the supplement.

Excipients are tremendously helpful in instances such as using magnesium stearate to ensure an even fill weight to meet label claim or using calcium silicate to stop a product from clumping.

9.) Lacking Patience in the Formulation Process

Although formulation is not the longest process in the grand scheme of creating a supplement, make sure to give it the quality time it deserves. The average time to formulate a supplement is two weeks, however, be accepting that it may take longer to reach your desired results.

10.) Formulating a supplement with no distinction

Last but not least, it’s important to implement distinction in your supplement’s formula. By establishing a unique selling proposition, you can better position your formula and standout in the market. There is a time and place for stock formulas, however, distinction in formulation is often what will set a supplement apart from its long list of competitors and drive its sales.

To learn more, contact your sales representative at:

28903 Avenue Paine
Valencia, CA 91355
United States

+1-661-775-2500

LIEFLABS.COM

©Copyright 2020 by Lief Organics. All Rights Reserved. Disclaimer: The information provided by Lief Labs on our website and in the GMP starter kit is for general informational purposes only. The information on the website and the GMP starter kit do not constitute legal or other professional advice. All information on Lief Labs’ website and in the GMP starter kit is provided in good faith, however we make no representation or warranty of any kind, express or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any information on our website, the GMP starter kit, and/or the links provided. Lief Labs is not liable for any damages arising in contract, tort or otherwise from the use of any information on our website or in the GMP starter kit. Because your business has its own unique needs, you should consult with legal counsel experienced in FDA and regulatory matters.