How Does FDA Private Label Products Work?

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Private label dietary supplements or PLDs are dietary supplements that are manufactured and distributed by a separate company rather than by the company that markets them under the brand name of a licensed pharmaceutical manufacturer. Under private label supplements the Federal Food Drug and Cosmetic Act (FDCPA), all dietary supplements must be regulated in a similar way to medications. Private label supplements do not meet this legal requirement, nor do they need to be under the jurisdiction of the FDA. As private label products, there is no control over the ingredients or the purity of the formulations, making them potentially more dangerous to consumers than the regulated pharmaceuticals they often resemble.

When a company chooses to use a private label supplement as opposed to a regulated supplement, they are not necessarily jeopardizing their business. In many cases, a supplement manufacturer will contract with an experienced third-party lab to produce an effective supplement. By working with a third-party company, the chances of having contaminated ingredients in the formulation are eliminated, making for a safer supplement. However, in other cases, the lack of FDA oversight allows the private label supplement manufacturer to use ingredients in ways not currently allowed by the FDA. While these supplements may be safer than unregulated supplements, there is not enough evidence to suggest that they are as effective as regulated products.

An increase in the use of prescription medications has led to an increase in the number of products on the market that are not regulated by the FDA. In many instances, companies that produce these non-FDA products can be found online, offering a wider range of private label supplements to consumers. The lack of regulations surrounding dietary supplement products allows them to include any ingredient that they choose, including potentially harmful substances. While it is illegal to sell nutritional supplements containing undeclared ingredients, many health claims can be made in advertisements, making it easy for consumers to believe that the supplement is providing them with health benefits not found in the product. While the FDA requires that manufacturers of prescription drugs are held to the same rigorous standards as those of diet and weight loss supplements, dietary supplement products can bypass this regulation in order to boost their sales.

Many dietary supplements that are not governed by the FDA also do not require any type of licensing or registration. This is great for consumers because it means that there is no way to know which companies have tested their private label supplements for contamination or effectiveness. Even with this lack of regulation, consumers have to take precautions when purchasing dietary supplements, making it important that companies make sure that they are selling top quality products. Many products carry a label that says they are “generally recognized as safe” or “natural.”

While both FDA and private label supplements generally have high quality ingredients, it is important to remember that even top quality products cannot be sold in stores unless they meet strict guidelines. All dietary supplements must go through a lengthy process before they become available for purchase. Although companies can list ingredients on packaging, most products undergo multiple steps in the manufacturing process. Soft gels are some of the main products that go through this long process, where high-end natural ingredients are combined with other chemicals and then turned into a solid form. While these supplements can be effective, they often fail to meet the requirements of the FDA and are banned from sale altogether.

The most effective way to ensure that you buy private label supplements that will pass FDA requirements is to work with a reputable contract manufacturer. A contract manufacturer will create a bottle with all of the right labeling and guarantee that all products will pass all FDA inspections. In addition to creating effective packaging, these contract manufacturers can also ensure that their products are accompanied by detailed written instructions on how to use them. When you work with a contract manufacturer to produce FDA-approved products, you get peace of mind that your health is in good hands.

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