Is What’s on the Label in the Bottle?
Quality manufacturing problems are a severe concern in the dietary supplement industry. For example, a recent JAMA research paper looked at 25 melatonin gummy products from different brands and found that 22 contained different amounts of melatonin than what was listed on their labels; one contained only 74 percent of the advertised amount of melatonin, while another had 347 percent of the labeled amount. Yet another product contained no detectable melatonin at all.
Other problems in the industry are contaminated dietary supplements, where vitamins, minerals, herbs, or other substances, are contaminated with harmful ingredients, such as heavy metals, pesticides, or bacteria.
This can happen due to inadequate manufacturing processes, poor quality control, or low-quality ingredients. Contaminated supplements can cause adverse reactions and health problems in those who consume them.
What is meant by Quality Control in the Manufacturing of Dietary Supplements?
Quality Control (QC) of dietary supplement manufacturing means a guarantee that the ingredients listed on the label are in the bottle. Supplement manufacturers are responsible for evaluating the safety and labeling of their products to ensure that they meet federal regulations before marketing. Supplement companies with poor manufacturing practices may have contaminated products with microbes, high heavy metals, or prescription drugs in them. For example, it is common for some male sexual enhancement supplements to contain drugs like Viagra in them without being listed on the label. The Food & Drug Administration (FDA) only becomes involved if a product is found to be adulterated or misbranded once it has already reached the market.
How consumers are assured their dietary supplements are from companies that follow Good Manufacturing Practices
The United States government regulates dietary supplement companies through the Dietary Supplement Health and Education Act (DSHEA). Under DSHEA, unlike foods, dietary supplements are allowed to use "nutritional support statements" but are not allowed to use claims that the product intends to diagnose, treat, cure, or prevent any disease. Lastly, dietary supplements are required by law to follow Good Manufacturing Practices (GMP), which ensures that products contain what they are labeled to contain and are not contaminated with harmful or undesirable impurities. As mentioned earlier, the FDA only spot-checks manufacturing facilities if a product has a problem. Hence, companies hire third-party organizations like NSF International (NSF), US Pharmacopeial Convention (USP), or UL Solutions (UL) for routine visits to the manufacturing facility to ensure products that have successfully passed an analysis of their quality, safety, performance, and claims of benefit are issued a U.S.-registered certification mark. Third-party testing agencies are not required by law but are used by reputable companies to help guarantee the dietary supplements produced contain the ingredients in the product labeling without contaminants.
Quality Control and Quality Assurance for XY Wellness Nutraceuticals
At XY Wellness, there is careful attention to combining the best vitamin, mineral, and botanical ingredients for specific health needs. In Additionally, the manufacturing facility where XY Wellness dietary supplements are packaged is overseen by Michael Schaeffer, a reputable nutritional supplement manufacturer in the industry for over 30 years. Lastly, along with testing all raw materials independently for impurities, Michael's manufacturing facility is frequently spot checked by a third-party agency UL Solutions, to guarantee good GMP. To listen to a detailed interview with Michael on the "A to Z" steps required to develop a quality supplement on the shelf, listen to my interview with him on any podcast platform or YouTube.
Closing Thoughts
Dietary supplements work best as part of an integrated program that includes diet, exercise, and other XY Wellness integrative roadmap lifestyle elements. It all works synergistically to optimize your prostate health. Dietary supplements at XY Wellness are formulated with your specific health needs in mind in a GMP-compliant facility with quality control practices second to none. As always, supporting you with your health journey is our pleasure.
Much Love!
Dr. Geo, Co-founder & Medical Director