Dr. Mercola Discusses the Regulations of Dietary Supplements



nowadays with more and more food additives in our diets and technologically advanced farming and food processing methods you can be more vulnerable to nutritional deficiencies taking nutritional supplements in addition to following a healthful diet and regular exercise routine is one way to take control of your health but our supplements regulated enough our strict standards in place to ensure customer product safety purity quality and effectiveness dr. Joseph Mercola sits down with Paul L Taffer of RFI which manufactures many of the highest quality supplements for Mercola to discuss the regulation of dietary supplements we're going to talk a little bit about regulation the supplement industry and I believe that there's a common perception by many and I think largely related to the fact that many federal authorities certainly critics of natural medicine the state really clearly and strongly believe that there's not enough regulation in supplement industry but I think if you look carefully at the facts that speak strongly against it and wonder if you could comment on the amount of regulation that we see in the food industry versus compare that to the supplementary under the drug industry glad to first welcome dr. Mercola thank you for visiting our Loveland Colorado facility we're very happy to have you here yes so it is what I perceive as a misnomer that the supplements industry is not a regulated industry we're absolutely regularly the industry is regulated by a federal regulation known as 21 CFR part 111 which establishes GMP requirements good manufacturing practices for the supplements industry we're also regulated by a law that went into effect in October of 1994 called the Shia dietary supplement health and education act that established a framework for acceptability of dietary supplements so there are federally mandated regulations that determine not only what is a dietary supplement but also what constitutes the proper safe and efficacious practices for delivering a supplement into the into the to the consumer the GMP is established for dietary supplement well as rigorous or more rigorous than those for the food chain so the food supply is regulated by 21 CFR part 110 establishes the GMP s for food well part 111 for dietary supplement is just as rudeness or more so that knows for food and probably only slightly less rigorous than those facing the pharmaceutical industry so that the notion that supplements aren't regulated is in my opinion a false one so you mentioned GMP standards and I think many people have heard of that but just believe short for journal manufacturing practices yes could you comment a little bit more specifically about what those are and how those relate to the to the supplement industry sure so good manufacturing practices are a whole set of rules standards and protocols by which manufacturers of dietary supplements need to establish their practices those are recently implemented they've been implemented over the period of the past six or seven years since they went into effect so but phased in over time they've been phased in over time but now the rule is valid forever just there is no exemptions anymore really for for putting into practice good manufacturing practices so these rules established the standards many procedures quality processes identification and analysis how you train and hire employees how you handle the maintenance and preventive maintenance of your equipment how you do the identification how you ensure safety of the products and how you ensure the purity and authenticity of the product those are very very important parts to that so safety purity and authenticity of the products are very important building blocks for the set of rules that that are in place and to enforce complies to these standards is there some type of auditing system that goes on at a regular basis and you discuss that and how that works yes so the FDA is is mandated by Congress to enforce those rules and they have field agents and departments throughout the country and they come out in and audit and inspect facilities and they write up and sometimes even shut down facilities who are grossly negligent and maintaining or don't maintain any kind geez at all the way many manufacturers go about handling the changing regulatory environment as many companies in their preparation for audits will hire third-party auditing companies these are companies that are also up to date with the most current regulations and are entrusted to come in and help manufacturers to establish those protocol procedures and protocols so that they are prepared for for a federal audit or an FDA or another audit when they become somewhat take like taking in high school the PSAT preparation for the SAT verb that's a good example in college so it's a prep prep test and do many companies engage these test audit firms they're becoming more and more popular yes and we certainly do that RFI we we employ a third party auditing organization and we have in all of our facilities we are now third parties certified we have every six months regular audits and we have inspections going along regularly and that our QC and QA Department put together on a regular basis so this is not required or mandated at this this time but it's just in preparation for a potential FDA order which is some ways this is somewhat like a an IRS audit you know they certainly don't want it everyone and it's random and infrequent I guess actually add that the difference is between the FDA and IRS is the FDA doesn't have to give you notice when they're going to use they can show up whenever they please but yes it's it's kind of like a training program that the rules are actually such that to be GMP compliant you don't need to have a third-party auditor you are certifying yourself but the truth is most companies will engage are many companies will engage with a third-party auditor because it it really is very helpful to have that rigor be tested the third-party auditor acts almost as if they were an agent and come in and put you through the put you through the process so it seems like you would be an agreement that these GMP procedures and policies that have been recently establish relative we've seen and implemented for in force for just about every company are supplement company it's a good idea however that complies to that is really somewhat challenging because if they doesn't have the resources to go and audit every supplement company so it would be a wise recommendation if you're going to be taking supplements to find one that is GMP compliant they have to be otherwise if they are they would be that they have an auto-fill be out of business but to find one that does this voluntary third-party objective certification audit once or twice a year and that would be a good indication that they passed these these relatively reasonable regulations to follow because it ensures your compliance to standard to a standard that will provide high quality supplements and that in fact you know meets all the standards of any policy whether it's supplements or foods or manufacturing any type of goods absolutely so a lot of people think that regulations are intrusive and difficult and certainly they cause greater Menten much lit greater layers of complexity in terms of the way we manage and handle our business but we absolutely welcome them so the reason we welcome them is that we feel like we're well suited to handle the changing environment for regulations we we've invested a lot of time and resource into building those kinds of capabilities and so we welcome that kind of of that kind of program and we're we're happy to to be compliant with it we also feel that it's a it's a great leg forward step forward for us in the way we work with our clients and allow them and help them also become compliant with these method there's a new and complex terrain for regulations so we welcome it actually all right well we're just delighted that you're following those processes that will ensure us that we are providing people with a highest quality supplement possible and if someone is interested in purchasing to supplement certainly it would strongly recommend to seriously consider doing the due diligence and finding a company that is in fact engaging these voluntary third party audits to the GMP procedures because it's going to be a really powerful indication that you are really following steps and procedures explain it maintain the church producing high quality something stay tuned for more informational videos about Mercola comms partnership with RFI manufacturing and our commitment to quality by helping you take better control of your health you

Leave a Reply

Your email address will not be published. Required fields are marked *