The Importance of FDA Compliance in Private Label Supplement Manufacturing

What is a Private Label Manufacturer?

A contract manufacturer is another term that is more frequently used in the industry to describe a private-label supplement maker. The manufacturer creates dietary supplements in stock formula private label form, which is prepared to receive your company's label.

All the product studies, formulation, ingredient procurement, mixing, and manufacturing were completed by the private label manufacturer. The item is available for purchase by a brand in two different forms: bulk delivery form or pre-bottled and prepared for their packaging line to attach your label to the item. A turn-key private label maker may help print your brand label, package the item for consumer sale, and even offer order fulfillment services to ship your consumer sales to them.

What classifies a product as a supplement?

Let's begin by outlining just what the FDA regards as a dietary supplement. A dietary supplement is, in accordance with the regulation's definition, at least one of the following:

"A mineral, vitamin, herb, or another botanical; an amino acid; a dietary item used by humans in dietary supplementation by raising the entire dietary intake; or a concentrate, metabolite, constituent, extract, or mix of any ingredients listed above."

Your product must have a supplement label that complies with FDA regulations if it falls under any of those headings.

FDA Compliance:

Natural offers the testing and verification to fulfill the most recent needs and ingredient validation, having knowledge of the complexities of FDA laws or FDA compliance for supplements.

All of the requirements for private label production are welcome, and we are pleased to assist. We offer a wide range of services, including anything from powder filling to encapsulation to bottling. We're here to take care of all of your production requirements, paying special attention to the little things. If you work with Natural, you are assured that your dietary supplements are produced and packed according to industry standards.

Are supplements regulated by the FDA?

The FDA is a federal organisation in charge of policing goods used by the general public for health-related reasons, including prescription medications, cosmetics, food items, tobacco, nutritional supplements, and even medical gadgets. These industries are subject to slightly different FDA regulations and roles.

The FDA is an agency of regulation that sets the standards for what statements supplement manufacturers can make about their goods. For instance, since supplements fall under the category of food items, they must adhere to rules regulating labelling and manufacture even if the FDA doesn't regulate their sale.

FDA mandates Good Manufacturing Practises (GMPs), which are enforced by inspections and give authorities the authority to prosecute, confiscate, and remove products that do not comply with standards or are deemed harmful in order to assure safety.

Individual dietary supplement products cannot be sold without an FDA licence. The Dietary Supplement Health and Education Act, which was passed in 1994, only allows dietary supplement companies to market goods containing ingredients that are either currently found in the food supply or were previously used in dietary supplements. Very stringent labelling standards, such as the statement of identification, statement of net quantity of contents, nutritional statistics, list of components, and business information, were included in this statute. In order to safeguard consumers from fraud, the first two elements on this list are ostensibly necessary. They help paint an accurate depiction of a product and its maker.

What else can we do to ensure the safety of dietary supplements?

Due to the lack of FDA oversight and the abundance of dietary supplement manufacturers, it can be challenging to identify which brands to believe in. Since FDA audits for GMPs are infrequent, it is essential to check for Third-Party certifications that guarantee the company is adhering to both the high criteria of the certifications and the GMPs established by the FDA.

FDA laws might be challenging to understand, which is just one of the reasons why private labelling supplements greatly reduces stress.

Regulations for FDA Supplement Labelling:

The front label panel and the informational panel are the two places on product packaging where supplements are commonly labelled. The side that customers are likely to view while they browse the store is the front label panel, which is what is on display on the shelf. The more technical details, like supplement facts, ingredients, and the name and address of the producer, are all contained in the information panel, which frequently sits just to the right of the front panel. The FDA mandates that a supplement label provide five different types of information.

The formal title of the supplement is Statement of Identity. Usually, the front label panel of a product will have this information prominently displayed.

Net Quantity of Contents Statement:

This statement specifies the quantity of the product that is contained in the container. On the front panel, it is often listed just underneath the claim of identification.

Nutrition Labelling:

The nutritional information on a supplement's label is its main component. 

Ingredient List:

Immediately below the supplement information is a list of all the ingredients used to make the supplement.

Name and Location of Business of the Manufacturer, Packers, or Distribution: The name, town, state, and zip code of the individual or company who produced, packaged, or distributed the nutritional supplement are listed in this section. Usually, this section is included immediately after the ingredient list.

Takeaway:

The FDA does not approve certain food brands, just as it does not approve specific dietary supplements. Instead, all nutritional substances that have been approved must adhere to rigid guidelines.

The FDA does keep a close eye on the production and labelling of nutritional supplements and inspects businesses to make sure they are operating in accordance with the law.

Manufacturers of supplements are in charge of adhering to FDA rules, and using private-label supplements can make this process much simpler for your business.

Natural have successfully implemented ISO 22000:2018 standards and are now in compliance with them.