July 26, 2018 is circled on the XYMOGEN calendar. On or before this date, we—like every food and supplement manufacturer—will have completed the task of modifying each and every XYMOGEN formula label to comply with the new rules set forth by the US Food and Drug Administration (FDA) in the Federal Register under “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.” These rules took effect on July 26, 2016.
Note: The images above are meant for illustrative purposes to show how the new Nutrition Facts label might look compared to the old label. Both labels represent fictional products. When the original hypothetical label was developed in 2014 (the image on the left-hand side), added sugars was not yet proposed so the “original” label shows 1g of sugar as an example. The image created for the “new” label (shown on the right-hand side) lists 12g total sugar and 10g added sugar to give an example of how added sugars would be broken out with a % Daily Value
The new rules reflect the FDA’s respect for updated scientific information; for instance, the link between diet and chronic diseases such as obesity and heart disease. The modifications, required on most food and all supplement labels, are intended to make it easier for consumers to make better informed food and supplement choices.
We cannot change all of the XYMOGEN formula labels overnight, but we want to get started on making the mandated modifications now. So, over the next two years, you can expect to see an increasing number of Supplement Facts or Nutrition Facts boxes on our labels that differ slightly from our current labels in information, layout, and font size.
The new rules will also impact the labels for private label customers; and like our XYMOGEN labels, the updates will take place as a gradual shift as opposed to modifications of all private labels at once.
We thank you for your patience and continuing support while our team diligently works toward the July 26, 2018 compliance deadline.
XYMOGEN® Copyright 2007-2016 – All Rights Reserved
XYMOGEN, the Orlando-based health sciences company, has earned Australia’s prestigious certification from the Therapeutic Goods Administration (TGA), that country’s equivalent to the U.S. Federal Drug Administration.
TGA certification is internationally recognized for having one of the world’s most rigorous GMP audit processes in the dietary supplement industry, standards that are very similar to pharmaceutical-level GMP requirements. XYMOGEN’s team spent two years of intense work and dedication in order to earn the certification.
Specifically, according to TGA requirements, XYMOGEN had to demonstrate the strictest level of adherence to manufacturing and quality standards and practices. TGA requirements exceed those established by the FDA.
Learn more about XYMOGEN products at www.xymogen.com.
There are many outstanding nutritional companies on the market and there are also many that shouldn’t exist. I discourage my patients from ordering from the internet or advertised products on television commercials.
When I select a product to increase my health, protect my body and protect myself from deficiencies, I look for SEVERAL criteria. And, I do the same for products that I make available for my patients.
First and foremost, I question where the research for that product originated. Was the research from a top university or a reputable research company with years of experience such as Biotics Research? Of course, I always avoid new startup companies, like the one I heard of that was in someone’s garage. (Fortunately, that one was stopped in time.)
The FDA (and we all have our own views about them) DOES examine the vitamin and herbal companies on a regular basis, even the ones we recommend in our clinic. Xymogen Inc. is the company that produces Ossophan for calcium that I recommend. They had the FDA checking their products again just last month. Fortunately, the company received the “A” grade and has been told that when they get the international “tag” – well – that’s the highest designation available!
Many companies do not test the products they sell. The ingredients might be purchased in bulk from a mass-produced company from “somewhere,” and many products that are sold over-the-counter’ are from these unknown, unregulated sources. They can be the same products with different labels. I have been offered to put my own label on a bottle and sell it as my product. Why would I ever even think of doing that, when I can use a great company with the research behind them ,and be very proud of being part of the educated practitioners who use their products?
Some of the companies we use also order bulk materials from companies, yet they know exactly where those ingredients came from – from day one. These ingredients are grown under strict guidelines and are all natural. The ingredients are also guaranteed before they are introduced into production.
It is not uncommon for some companies to use ingredients from an unregulated, overseas market (even medical drugs come in from overseas). Thousands of dollars of materials were rejected because they contained mercury. If that company had relied on the supplier’s recommendation we would all be ingesting mercury!
I do my own research and make certain that the products recommended to my patients are pure, natural and well researched.
It’s been all over the news the past few weeks. Certain vitamins and minerals do not do what they claim to do. First of al,l I check to see who did the study (usually a drug company). Then, I try to find out what companies they tested. (It’s never the ones I use.) Right now, one popular company is under a lot of heat with the FDA. I have not used that company in 38 years. That is when I found out their practices were not good at all. If something is made cheaply, well, you get what you pay for.
We use companies for all of the above reasons PLUS affordability. If it is still too expensive for you, ask for our help. We can always modify your program. With eating better, exercising, good mental attitudes and sleeping better – you won’t need all of the supplements. Our goal is to always – GET HEALTHY. BE HEALTHY. STAY HEALTHY.
Does the FDA regulate dietary and herbal supplements? YES.
“FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
- FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market….”
Read more here: http://www.fda.gov/Food/DietarySupplements/