What does FDA certification really mean? Unpacking the Labeling Behind Supplements.
Maybe you saw the words “FDA certified” on a company’s website or in a commercial promoting a product or treatment. Some marketers may say their products are “FDA approved”, but how can you know for sure what that guarantees, and what it doesn’t? What does an FDA certification really mean? Let’s unpack the labelling behind …
Maybe you saw the words “FDA certified” on a company’s website or in a commercial promoting a product or treatment. Some marketers may say their products are “FDA approved”, but how can you know for sure what that guarantees, and what it doesn’t? What does an FDA certification really mean? Let’s unpack the labelling behind supplements.
The FDA assumes the crucial responsibility of safeguarding public health by overseeing the regulation of a wide array of products. These include human drugs, biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products emitting radiation.
While not all products are subjected to premarket approval, this process involves a meticulous evaluation conducted by FDA experts to assess safety, quality, and effectiveness before granting permission for the product to be sold. Nevertheless, the FDA’s vigilance extends beyond premarket approvals, as they also focus on products that are already on the market, allowing some items to be available without prior approval. Notably, in the realm of dietary supplements, the FDA regulates them as food rather than drugs.
Despite this categorization, it’s important to note that many dietary supplements contain potent ingredients with substantial biological effects. These effects may potentially interact with ongoing medications or existing medical conditions. As a consumer, it is prudent to carefully scrutinize supplement labels before making a purchase, ensuring that they align with your specific health needs and do not pose any risks.
What can the FDA do?
The FDA can also take action against supplement manufacturers that make false or misleading claims about their products. For example, a supplement that claims to cure a disease is considered a drug and must undergo the same testing and approval process. If a supplement manufacturer makes such a claim without the proper evidence, the FDA can take enforcement action against them.
Despite these regulatory measures, there have been cases of dietary supplements that have caused harm to consumers. One example is the weight-loss supplement ephedra, which was banned by the FDA in 2004 after it was linked to heart attacks and strokes. Other supplements, such as some herbal supplements, have been found to contain harmful contaminants. They have also been adulterated with prescription drugs.
What are the top 5 things to look for on a supplement label?
1. Where is it made?
Why is it important where a supplement is made? Some countries have different regulations around ingredients, contamination standards and factory conditions which all affect the quality of the product. In the United States, facilities that manufacture, process, pack, or hold dietary supplements for consumption must register with FDA. This means that there are high standards for manufacturing. You should always look for products that are made in the US to ensure quality and integrity. Plus, you can reduce your carbon footprint!
2. Is it clinically proven?
Clinically proven means that a product is tested in a well-designed study. In addition, the study needs to be conducted properly, demonstrate significant positive results, be written up and submitted to a proper, peer-reviewed journal and then determined to be of scientific merit and value to be published. This basically means that there is scientific evidence that the product you are purchasing works. If, however, the label also says “These statements have not been evaluated by the FDA …”, then the company can legally say that without it necessarily being true. So, read the fine print and head to the company’s website to read about their process and verify their claims.
3. Is it FDA registered?
The FDA possesses the power to conduct inspections of regulated facilities to ensure their adherence to current good manufacturing practices. When a product is FDA registered, it is required to disclose all the ingredients used in its formulation. As a result, this serves as another essential indicator of a product’s commitment to maintaining high-quality standards.
4. Is it non-GMO?
GMO stands for genetically modified organism, and it is now prevalent in various industries, including food production. However, opting for non-GMO foods goes beyond just avoiding genetically modified ingredients. Non-GMO foods are characterized by their exclusion of chemicals, preservatives, or harmful toxins that could pose significant health risks in the long run.
The primary concerns associated with genetically modified foods pertain to potential adverse health effects such as the transfer of antibiotic resistance, toxicity, and allergenicity. If you prioritize safety and seek products made with top-notch natural ingredients, be vigilant for the “non-GMO” label. By doing so, you can ensure that you are making choices that align with your health and quality standards.
5. Does it use animal products and artificial flavors?
A recent report has shed light on the fact that around half of dietary supplements on the market contain ingredients derived from animals. This study was conducted in the context of a $55 billion industry, aiming to address significant information gaps regarding the environmental and animal welfare implications of these products. Interestingly, most supplement companies do not openly disclose the presence of animal-derived ingredients in their formulations.
The report highlights that among the most prevalent animal-derived supplement ingredients are magnesium stearate and gelatin, which are sourced from animal byproducts obtained from cows, pigs, and sheep. While these ingredients and artificial flavors may not pose immediate health risks, they could indicate the use of filler substances or a lower standard of quality in the supplements.
For individuals concerned about their environmental impact, opting for vegan supplement products can be a step towards making a positive contribution to the health of our planet. By choosing such products, consumers can align their supplement choices with their values and promote animal-friendly and eco-friendly practices within the industry.
Conclusion
To ensure that a dietary supplement is safe and properly labeled, consumers should look for information on the product label. The label should include the name of the supplement, the name and address of the manufacturer or distributor, a complete list of ingredients, and the serving size and number of servings per container. The label should also include any warnings or cautions, such as “not for use by pregnant or nursing women”. You should be on alert with supplements that make lofty claims. To learn more about Beelith’s rigorous supplement standards, head to our website home page.
References
Center for Food Safety and Applied Nutrition. “Dietary Supplement Labeling Guide.” U.S. Food and Drug Administration, www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-dietary-supplement-labeling-guide. Accessed 21 July 2023.
Steve Jenkins is an accomplished leader in the pharmaceutical industry. He’s the Executive Chairman of Beach Pharmaceuticals, a role he’s been flourishing in since January 2017. Jenkins brings a solid scientific foundation to his work, holding a Bachelor of Science degree in Chemistry from the University of Florida. His strong background and many years of experience in the industry give him unique insights and a deep understanding of the field.
What does FDA certification really mean? Unpacking the Labeling Behind Supplements.
Maybe you saw the words “FDA certified” on a company’s website or in a commercial promoting a product or treatment. Some marketers may say their products are “FDA approved”, but how can you know for sure what that guarantees, and what it doesn’t? What does an FDA certification really mean? Let’s unpack the labelling behind …
Maybe you saw the words “FDA certified” on a company’s website or in a commercial promoting a product or treatment. Some marketers may say their products are “FDA approved”, but how can you know for sure what that guarantees, and what it doesn’t? What does an FDA certification really mean? Let’s unpack the labelling behind supplements.
What is the FDA and what do they do?
The FDA is the Food and Drug Administration.
The FDA assumes the crucial responsibility of safeguarding public health by overseeing the regulation of a wide array of products. These include human drugs, biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products emitting radiation.
While not all products are subjected to premarket approval, this process involves a meticulous evaluation conducted by FDA experts to assess safety, quality, and effectiveness before granting permission for the product to be sold. Nevertheless, the FDA’s vigilance extends beyond premarket approvals, as they also focus on products that are already on the market, allowing some items to be available without prior approval. Notably, in the realm of dietary supplements, the FDA regulates them as food rather than drugs.
Despite this categorization, it’s important to note that many dietary supplements contain potent ingredients with substantial biological effects. These effects may potentially interact with ongoing medications or existing medical conditions. As a consumer, it is prudent to carefully scrutinize supplement labels before making a purchase, ensuring that they align with your specific health needs and do not pose any risks.
What can the FDA do?
The FDA can also take action against supplement manufacturers that make false or misleading claims about their products. For example, a supplement that claims to cure a disease is considered a drug and must undergo the same testing and approval process. If a supplement manufacturer makes such a claim without the proper evidence, the FDA can take enforcement action against them.
Despite these regulatory measures, there have been cases of dietary supplements that have caused harm to consumers. One example is the weight-loss supplement ephedra, which was banned by the FDA in 2004 after it was linked to heart attacks and strokes. Other supplements, such as some herbal supplements, have been found to contain harmful contaminants. They have also been adulterated with prescription drugs.
What are the top 5 things to look for on a supplement label?
1. Where is it made?
Why is it important where a supplement is made? Some countries have different regulations around ingredients, contamination standards and factory conditions which all affect the quality of the product. In the United States, facilities that manufacture, process, pack, or hold dietary supplements for consumption must register with FDA. This means that there are high standards for manufacturing. You should always look for products that are made in the US to ensure quality and integrity. Plus, you can reduce your carbon footprint!
2. Is it clinically proven?
Clinically proven means that a product is tested in a well-designed study. In addition, the study needs to be conducted properly, demonstrate significant positive results, be written up and submitted to a proper, peer-reviewed journal and then determined to be of scientific merit and value to be published. This basically means that there is scientific evidence that the product you are purchasing works. If, however, the label also says “These statements have not been evaluated by the FDA …”, then the company can legally say that without it necessarily being true. So, read the fine print and head to the company’s website to read about their process and verify their claims.
3. Is it FDA registered?
The FDA possesses the power to conduct inspections of regulated facilities to ensure their adherence to current good manufacturing practices. When a product is FDA registered, it is required to disclose all the ingredients used in its formulation. As a result, this serves as another essential indicator of a product’s commitment to maintaining high-quality standards.
4. Is it non-GMO?
GMO stands for genetically modified organism, and it is now prevalent in various industries, including food production. However, opting for non-GMO foods goes beyond just avoiding genetically modified ingredients. Non-GMO foods are characterized by their exclusion of chemicals, preservatives, or harmful toxins that could pose significant health risks in the long run.
The primary concerns associated with genetically modified foods pertain to potential adverse health effects such as the transfer of antibiotic resistance, toxicity, and allergenicity. If you prioritize safety and seek products made with top-notch natural ingredients, be vigilant for the “non-GMO” label. By doing so, you can ensure that you are making choices that align with your health and quality standards.
5. Does it use animal products and artificial flavors?
A recent report has shed light on the fact that around half of dietary supplements on the market contain ingredients derived from animals. This study was conducted in the context of a $55 billion industry, aiming to address significant information gaps regarding the environmental and animal welfare implications of these products. Interestingly, most supplement companies do not openly disclose the presence of animal-derived ingredients in their formulations.
The report highlights that among the most prevalent animal-derived supplement ingredients are magnesium stearate and gelatin, which are sourced from animal byproducts obtained from cows, pigs, and sheep. While these ingredients and artificial flavors may not pose immediate health risks, they could indicate the use of filler substances or a lower standard of quality in the supplements.
For individuals concerned about their environmental impact, opting for vegan supplement products can be a step towards making a positive contribution to the health of our planet. By choosing such products, consumers can align their supplement choices with their values and promote animal-friendly and eco-friendly practices within the industry.
Conclusion
To ensure that a dietary supplement is safe and properly labeled, consumers should look for information on the product label. The label should include the name of the supplement, the name and address of the manufacturer or distributor, a complete list of ingredients, and the serving size and number of servings per container. The label should also include any warnings or cautions, such as “not for use by pregnant or nursing women”. You should be on alert with supplements that make lofty claims. To learn more about Beelith’s rigorous supplement standards, head to our website home page.
References
Center for Food Safety and Applied Nutrition. “Dietary Supplement Labeling Guide.” U.S. Food and Drug Administration, www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-dietary-supplement-labeling-guide. Accessed 21 July 2023.
Article by Steve JenkinsSteve Jenkins is an accomplished leader in the pharmaceutical industry. He’s the Executive Chairman of Beach Pharmaceuticals, a role he’s been flourishing in since January 2017. Jenkins brings a solid scientific foundation to his work, holding a Bachelor of Science degree in Chemistry from the University of Florida. His strong background and many years of experience in the industry give him unique insights and a deep understanding of the field.