As Americans, we rest assured that the products we put into our bodies are safe. From the foods and beverages we consume to the cosmetics we use to the medications we take, the US Food and Drug Administration (FDA), an agency of the federal government, regulates and oversees the development and production of many of these products. The FDA has broad regulatory authority to monitor products and may issue recall notices when warranted or public safety is threatened.
Interestingly, the rules for dietary supplements are not as stringent. While the FDA does follow up on issues related to supplements, they do not have oversight for testing or regulating supplements. This places much more responsibility on the supplement producer/manufacturer to ensure the purity of their products and the safety of their customers.
In light of these facts, you may be wondering how the quality of your mushroom powder supplement stacks up to other products on the market. With so much responsibility for product safety squarely on the manufacturer’s shoulders, as a well-informed shopper, you will want to take safety into account when choosing a supplement.
Read on for specific suggestions regarding assessing mushroom supplement quality.
Regulations for Supplements
For the products over which the FDA has jurisdiction, excluding mushroom supplements, the agency does not conduct its own testing. Instead, manufacturers are required to submit data from in vitro (laboratory) testing and in vivo (animal and human) clinical trials. The FDA reviews the data and if the benefits outweigh the risks, they grant approval. The products in the following categories are subject to these requirements:
- Blood, vaccines, and biologics
- Animal and veterinary products
- Medical devices
- Radiation-emitting devices
- Tobacco products
The requirements for dietary supplements, however, are markedly different. The FDA does not review dietary supplement products for safety or effectiveness before they are marketed. Therefore, it is up to the manufacturers and distributors of dietary supplements to make sure their products are safe before they go to market.
So what regulations must they follow? There is a requirement to produce quality supplements that do not contain contaminants or impurities. They must also be labeled properly. These requirements are outlined in the FDA’s current Good Manufacturing Practice (cGMP) for Supplements, a document that is regularly updated with specific guidelines for safe manufacturing, packaging, labeling, and storage practices.
Ensuring Optimal Mushroom Supplement Quality
Here are the major steps we take to make sure our customers receive the highest quality products.
Ensuring Product Purity
To ensure that each of our mushroom species is identified properly and cultivated in its ideal growing conditions, we employ expert mycologists (scientists who study yeasts, mushrooms, and other fungi) to supervise the process. In this way, we can provide the purest product and our customers receive exactly the mushroom species they intend to purchase.
Maintaining Control of the Growing Process
Though many functional mushroom species usually grow on decaying wood in forests around the world, collecting them in nature is both impractical and potentially dangerous to our customers.
- Meeting the demands of our customers, while maintaining safety, would not be possible if we didn’t take into account the environment in which our mushrooms are grown. In some countries, regulations on growth environments aren’t as tight as they are in the United States, creating the potential for an issue of a toxic environment.
- Since fungi are nature’s decomposers and recyclers, mushrooms absorb and accumulate many nutrients from their environment. Unfortunately, they may also accumulate environmental toxins and pass those on to people who consume them.
For these reasons, Om chooses to cultivate and grow all of our mushroom species in our climate-controlled and highly-regulated, indoor farm in Carlsbad, CA. In this environment, we use filtered air and water and pure organic oats as a growth medium. This way, our mushrooms are free from environmental toxins, bugs, and pesticides, and they are completely safe.
Controlling the Supply Chain
Some functional mushroom companies source their mushrooms exclusively from China. They may even suggest that only mushrooms from China have any real value. By contrast, Om chooses to control the supply chain and the process from start to finish; all mushrooms are grown locally. By owning the process and not relying on imported mushrooms, we can ensure consistency from batch to batch, a claim not all mushroom supplement companies or brands can make.
Committing to Transparency
Om is committed to exceeding minimum labeling requirements and providing customers with complete and accurate information. We tell you exactly what parts of the mushroom you are getting and where they were grown, so you can make informed decisions. Product labeling is subject to FDA cGMP guidelines. For supplements, that means the labels must contain the following information:
1) the name of the dietary supplement
2) the amount of the dietary supplement
3) the nutrition labeling
4) the ingredient list
5) the name and place of business of the manufacturer, packer, or distributor
Since our products are not marketed as drugs, they have not been through the laboratory testing and clinical trials that would earn FDA approval. For this reason, when we make a specific health and wellness statement about the benefits of using mushroom supplements, we use this symbol (‡) with the disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease” to remind customers that our products are functional food supplements, not FDA-approved drugs.
Seeking Third-Party Certification
When the grower/manufacturer maintains control of the process from start to finish and submits their production process, facilities, and products for third-party testing, they clearly have their customers' best interests in mind. By monitoring and regulating every stage of the cultivation and manufacturing process, Om puts our customers first.
Our consumers can be doubly sure that the highest quality control standards have been observed. In addition, each of our products/processes receive these third-party certifications:
- US Department of Agriculture Organic
- Non-GMO Project Verified
By adhering to strict quality standards and obtaining these third-party certifications, Om can assure our customers that our mushroom supplement quality is unparalleled. Our products are suitable for vegan diets and are keto- and paleo-friendly.
Taking Our Responsibility Seriously
As a producer of dietary supplements, we at Om Mushrooms take our responsibility very seriously. The products we bring to the market are the highest in mushroom supplement quality. By controlling every step of the cultivation, dehydration, milling, packaging, and labeling process ourselves, we are able to adhere to the strictest quality standards. We go one step further by seeking third-party testing and verification. In doing so, we provide our customers with products we can stand proudly behind. Our commitment to transparency helps our customers make informed decisions as they select mushroom powder supplements for optimal health benefits.
Om Mushroom supplement quality is second to none. From controlling the entire cultivation, milling, and packaging process to acquiring third-party endorsements, we at Om ensure that our mushroom powder products are organic, kosher, non-GMO, gluten-free, and prepared under the Current Good Manufacturing Practices outlined by the FDA. To take advantage of the benefits of our exceptional, functional mushroom products, shop now or subscribe to save!
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