The Food and Drug Administration (FDA) regulates the safety and efficacy of drugs and medical devices sold in the United States. The FDA also oversees the manufacturing process of these products.
The FDA has recently become concerned about the security of the drug supply chain. They believe that there are too many instances of counterfeit drugs being sold in the U.S., including weight loss supplements.
What Is the drug supply chain security act?
In March 2011, Congress passed a law called the “Drug Supply Chain Security Act (DSCSA)”. This new law requires manufacturers who take prescription medications for sale in the U.S. to follow certain guidelines for their product quality control processes. These include:
• Ensuring that all raw materials used in making the medication come from legitimate suppliers.
• Making sure that finished goods meet specifications before they leave the factory.
• Keeping records on how each batch is made so that if something goes wrong with one batch, you can identify someone did not follow correctly which steps.
• Testing every unit produced by your facility to ensure compliance with federal regulations.
• Having an effective system in place to prevent counterfeiting.
• Providing documentation showing that your company complies with this legislation.
Are weight loss products drugs?
No. Weight loss products such as dietary supplements are regulated differently than pharmaceuticals. Pharmaceuticals must go through rigorous testing before the FDA approves them. Dietary supplements may contain ingredients that help people lose weight but don’t require approval by the FDA. Instead, supplement makers only need to prove that their products aren’t harmful.
The DSCSA applies to any manufacturer who makes prescription medicines for sale in the U S. It covers both over the counter and prescription weight loss products. However, some companies have already taken action to comply with the DSCSA. Others will need to do more work to be compliant.
Does the drug supply chain security act applicable to weight loss products?
The Food & Drug Administration, which regulates food and medicine in the US, says that the DSCSA applies specifically to “prescription” drugs. But what exactly makes up a prescription drug? According to the FDA’s website, a prescription drug is anything intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.
So, while weight loss products like diet pills might fall under the category of “dietary supplements,” they’ve still considered prescription drugs because they’re meant to treat diseases.
The Drug Supply Chain Security Act requires that certain information regarding the manufacture of prescription drugs be maintained in order to track where the drugs came from and whether they met quality standards. Manufacturers also need to keep records of when batches of drugs left their facilities and how many units we manufactured during each production run.
If your weight loss product contains active ingredients like ephedra, caffeine, green tea extract, chromium picolinate, yohimbine hydrochloride, etc., then yes, your product would fall under the purview of the DSCSA because those substances might cause health problems. If your product doesn’t contain any of these ingredients, however, then it wouldn’t qualify as a drug. It would instead consider your product a food or beverage.
So now we know why the DSCSA was created. The law exists to protect consumers against counterfeit medications. And since most weight loss products sold today are actually foods rather than actual prescriptions, the DSCSA shouldn’t affect them at all. This means that even though manufacturers of weight loss products should take precautions to make sure their products are safe, there isn’t much else they can do about fake versions of their own products.