FDA Approved Stem Cell Supplements: Does The FDA Approve Stem Cell Supplements?

No, the Food and Drug Administration doesn’t approve stem cell supplements. And while there are no FDA approved stem cell supplements in the market, that doesn’t mean the agency isn’t part of their regulation.

The FDA regulates stem cell supplements by inspecting companies that market stem cell supplements with how compliant they are to run their facilities. The FDA also requires organizations to ensure that their products are safe before they market them for consumption. But the FDA does not directly approve any supplements at all. That's why you need to understand what makes a supplement useful, so that you don't accidentally choose one that may harm you or your family.

Cerule’s StemEnhance ULTRA is a stem cell supplement that meets these standards. The stem cell supplement is backed by clinical studies and extensive research. It is also safe and has been well-received by its consumers, especially in terms of efficacy, reliability, and compliance.

Does The FDA Approve Stem Cell Supplements?

The FDA doesn’t approve stem cell supplements in terms of their safety and effectiveness. Stem cell supplements, which are categorized as a dietary supplement, can be marketed by companies even without a notification from the agency.

The FDA, however, requires companies that manufacture stem cell supplements to submit a pre-market safety notification 75 days before marketing those with specific “new dietary ingredients.” This also only applies to dietary supplements that didn’t get marketed in the United States prior October 15, 1994.

Meanwhile, stem cell supplement companies must make sure that their products are safe. These items must likewise comply with quality and labeling requirements.

Other aspects the FDA is also inspecting are how these companies’ facilities are being run and managed. Whenever adverse events are reported or public health concerns intensify surrounding the safety of a dietary supplement, such as stem cell supplements, the FDA may take action.

What exactly does the FDA do?

The FDA protects public health by ensuring the safety, efficacy, and security of:

  • Human and veterinary drugs
  • Biological products
  • Medical devices
  • Food supply
  • Cosmetics
  • Products that emit radiation

The FDA is also responsible for regulating the tobacco products’ manufacturing, marketing, and distribution. This responsibility intends to protect the public health, while also reducing tobacco use by minors.

Another significant role the FDA is involved in is in the country's counterterrorism ability. It does its part by making sure the food supply’s security, along with encouraging the development of medical products. The latter ensures that the country can respond accordingly when there’s emerging deliberate and natural public health threats.

What stem cells are FDA approved?

Stem cells that are approved by the FDA are stem-cell based products that comprise blood-forming stem cells or hematopoietic progenitor cells obtained from cord blood. These can be used in the US and are approved only for limited use by the patients.

Bone marrow is also used for treatments. However, the FDA rarely regulates its use.

As of 2022, here’s the list of diseases treated by stem cells:

  • Spinal muscular atrophy (SMA)

  • Damaged cartilage

  • Melanoma

  • Large B-cell lymphoma

  • Mantle cell lymphoma

  • B-Cell ALL

  • Prostate cancer

  • Other cancer types

  • Damaged cartilage

  • Receding gums

  • Damaged cartilage

  • Leber congenital amaurosis

  • Specific types of facial wrinkles

Meanwhile, there’s not a list of FDA approved stem cell clinics. The reason behind this is that there are no clinics which are approved by the agency.

Why is the FDA against stem cell therapy?

The FDA isn’t against stem cell therapy. The agency only has safety concerns for unproven stem cell treatments. Accordingly, unproven stem cell therapies can be especially unsafe, ultimately for those who haven’t sought opinions from healthcare practitioners before the procedure.

Other concerns raised by the FDA relative to unproven stem cell treatments include:

  • Reactions from administration sites

  • The cells’ ability to move from placement sites then change to inappropriate types and multiply

  • Cells’ failure to work or thrive as expected

  • Introduction of new tumors

When stem cell-based products are used in ways that are unapproved, a slew of judicial and administrative actions are bound to be placed by the FDA against the manufacturing companies.

Where can providers go for more information about FDA regulation of stem cell products?

Providers can go to the FDA’s official website for more information about its regulation of stem cell products.Some of the crucial information you’ll find on the site includes stem cell uses and the FDA regulation, FDA-approved products derived from stem cells, safety concerns for unproven stem cell treatments, and the actions of the agency against unapproved stem cell products. The FDA site also features advice for consumers who consider stem cell therapies as an option.

What is the best stem cell supplement?

  • Resveratrol

  • Spirulina

  • Quercetin

  • Astragalus root

  • Glucosamine/chondroitin

  • Blueberry powder

  • L-carnosine

  • Curcumin/turmeric

  • Green tea extract

  • Leucine

  • Glycine

  • Vitamin C

  • Fisetin

What supplements increase stem cells?

Supplements that increase stem cells include spirulina, quercetin, and astragalus root. Other supplements that may boost stem cells are:

  • Decreasing sugar intake
  • Decreasing calories
  • Staying active and introducing an alternative, health-based lifestyle
  • Cessation of smoking
  • Reduction of alcohol intake
  • Avoidance of harmful products

Do stem cell supplements work?

Stem cell supplements may work, but their efficacy will depend on several factors, such as the overall health of the consumer, the severity of the condition, and the consistency of the intake.

As stem cell supplements are typically advised to be taken when one undergoes a stem cell treatment or therapy, it is imperative that you consult with a healthcare professional first before taking this route.

What are stem cell supplements good for?

Stem cell supplements are good for consumers who have just undergone stem cell therapy or treatment. These supplements may promote the benefits that are already established and associated with specific stem cell therapies or treatments.

There are several stem cell supplements as well deemed to promote the productivity of mesenchymal stem cells in the human body. According to studies, these supplements may improve the effectiveness, while fostering healthy environments in which they can thrive and remain healthier for a longer period.

As with any other stem cells, the more effective they are, the more health gains are up for grabs.

Does Medicare cover stem cell therapy?

Stem cell therapy under Medicare is covered. But there are caveats, as with any other coverages. For instance, the insurance company only covers certain cancer types or bleeding disorders like sickle cell disease.

Likewise, Medicare covers two types of transplants that use stem cells—autologous stem cell transplantation and allogeneic stem cell transplantation. In addition, the only FDA-approved stem cell therapies are for the following conditions:

  • Blood disorders

  • Immune system disorders

  • Cancers

As for whether Medicare covers stem cell injections, the company may cover them as long as the injections are approved by the FDA.

Does any insurance cover stem cell therapy?

A few insurance companies now cover stem cell therapies. Accordingly, some firms already cover those that involve stem cell procedures, featuring bone marrow aspiration concentration (BMAC).

Whenever you’re not sure whether the therapy or treatment is covered, it’s best that you get in touch with your insurance provider for confirmation.

Currently, no major insurance companies cover stem cell therapies.

Conclusion

Stem cell therapies and treatments have already been proven to come with many benefits, such as pain relief, increase in functionality, more range in motion and flexibility, prevention of nerve damage, and a lot more. And while these are welcome developments, the international medical community, along with its consumers, is still universally on the fence.

The same can be said with stem cell supplements. No doubt these stem cell capsules, as additives, may help you maximize the benefits of a stem cell treatment or therapy. But like the latter alternatives, these supplements still need a lot of research and convincing.

Cerule’s StemEnhance ULTRA stem cell supplement is one product that reminds us how far stem cell research has already gone, in terms of progress and innovation. And one that also ultimately meets the FDA standards.

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