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GMP: As Good As It Gets (Part 1)

May 1, 2023

MT Brands has always been proud of the fact that we are a GMP, HACCP facility, fully certified by the SGS.

Sounds impressive, right? But what exactly do those acronyms even mean? And why should a distributor or consumer of our products care?

HACCP SealGMP SealIn order to understand how crucial these factors are to a manufacturing and co-packing facility like ours, check out our four-part series that addresses the following questions:

What is the Role of the FDA?

Most people take for granted the food they eat or the medications they take. They simply trust that the products are safe to consume, not giving the manufacturer any thought before taking a bite of their apple or swallowing a couple pills for their headache.

But where does this blind trust come from? The U.S. Food and Drug Administration (FDA).FDA Graphic

In the backs of all our minds, we know there are strict rules regulating food and drug manufacturers and that companies must comply if they want to stay in business. We can’t possibly ensure their compliance on our own, so we have placed our collective faith in the FDA to do so on our behalf. This gives us peace of mind and the freedom to ingest whatever we like without constantly having to worry, knowing that the FDA has it covered.

However, food and drugs are not the only things that the FDA regulates. In fact, it is estimated that about 20 cents of every dollar we spend is on a product regulated by the FDA.

General product categories include:

  • Food and Beverages
  • Drugs
  • Cosmetics
  • Veterinary Products
  • Tobacco Products
  • Biologics
  • Medical Devices
  • Electronic Products (that give off radiation)

Dietary Supplement Regulation

So the FDA is involved in many of the products that you use every day, from your toothpaste and shampoo to your microwave oven. But what about the dietary supplements you take?

The FDA does have a major role in the regulation of the dietary supplement industry. Although technically considered food by the FDA, dietary supplements are intended to add to or supplement the diet, making them different from conventional food. They are also not considered drugs, as they do not treat, diagnose, cure, or prevent diseases. Therefore, dietary supplements are covered under a separate set of regulations than either food or drug products.

The FDA regulates the processing, manufacturing, labeling, and packaging of dietary supplements.  This is required by the Dietary Supplement Health and Education Act (DSHEA), an amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act.

Yes, even more acronyms, and these are especially important ones because they are the law.

This legislation requires dietary supplement companies to have evidence that their products are safe and that the label is not false or misleading.  The FDA may pursue enforcement actions against any company or product that is found to have safety issues, manufacturing violations, or improper marketing practices.

Although MT Brands products are not dietary supplements and we are not registered with or regulated by the FDA, we do adhere to Title 21 of the Code of Federal Regulations, particularly Parts 210 and 211. These codes outline the agency's current Good Manufacturing Practices (GMPs or cGMPs).

While some companies may fear or even hate the FDA, we at MT Brands believe that those are the types of companies that should be avoided. We understand that the FDA is absolutely vital for consumer safety and protection. We agree with their mission, comply with their guidelines, and respect their authority completely.

Coming Up NextComing Up Next sign

DSHEA authorized the FDA to establish GMPs for dietary supplements. Find out more about GMPs in Part 2 of our series.

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