You Know Something's Happening, But You Don't Know What It Is . . .
While the industry is approaching the preparation for enforcement of the Dietary Supplement GMPs with its usual 11th hour strategy of action just before the hammer falls – another happenstance has surfaced. This one could have some significance and could be the death knell for a portion of DSHEA if not the whole of it. For those of you who believe that this is Chicken Little speaking – please note that this legislation has notable impact and the odds are you are only dimly aware of it.
On May 26, 2009 our friends in Congress (Mr. Waxman and Mr. Dingell specifically) introduced a bit of legislation that is designed to make the public feel safer concerning their food. On the heels of salmonella in spinach and melamine in infant formula, this timely presentation is understandable. Without an extensive reading of the draft legislation this sure sounds like a good idea. The Food Safety Enhancement Act of 2009 (note that the acronym for this is FSEA so very close to DSHEA as to be disconcerting) has a title we can all rally around. Reading the summary as presented also makes it sound good. Well, that’s the intent – to make it all sound good. A little closer look reveals a different agenda among the twists and turns. That agenda includes (and this should come as no surprise to those who watch this sort of thing) introducing additional means of getting after that miscreant industry – the Dietary Supplement Industry. There will be more in-depth discussion of this as it moves along the congressional trail but the sponsorship of the bill and the climate tends to indicate that this one has a good likelihood of getting somewhere. Let’s just look at some of the cursory concerns the Natural Products industry should note and act on first. These bits are lifted from the Summary of the Draft Legislation.
Facilities Registration: No big deal. This proposal is different in that all facilities foreign and domestic are required to register ANNUALLY. This allows for the payment of fees ANNUALLY in order to continue to do business. Still no big deal but there is a requirement for a US agent as primary contact point for the foreign manufacturers. There are ramifications here for that agent if you understand some of the “exporters goods coming to this country. Still, so far seemingly harmless. Unless you look a little closer still. Using materials from a company that is not registered or whose registration has lapsed renders the products that use this material as Adulterated. This would then likely cancel the registration of your facility and everything you made would then become adulterated if it entered the marketplace. Oh yeah – if your facility is suddenly removed from the approved list you have an “informal hearing” setting in which to appeal.
Identifies food safety problems before they occur: Sounds great. An ounce of prevention and all of that. Well if you look a little closer at the text of the proposed legislation you find the implementation via law of a HACCP program for all foods. The evaluation of critical control points in the manufacturing operation will need to be identified and these requirements will apply to foreign manufacturers as well. You will have the burden of assuring these foreign manufacturers meet the standards set up.
Increased Inspection Frequency: The revenues generated from the user fees will be used in part to step up inspection of manufacturing facilities. Have you organized your GMP strategies yet? You might wish to. There is also a tiering of classifications of manufacturers from “low risk” to “high risk.” Wonder where the Natural Products facilities will fall.
Prevention of Food Safety Problems: Who can argue with this? Well a little closer look at the draft legislation reveals that there are some interesting definitions that get incorporated in the Federal Food, Drug and Cosmetic Act that were not there before. It seems that this legislations is crafted to put a tremendous amount of regulatory detail into legislative presentation. Including the subsetting of the importance of adherence to GMPs to a secondary level. Complying with GMPs becomes secondary to the overall term “Preventive Controls.” It is these Preventive Controls that will become the standard for compliance with GMPs being a mere subset along with “Sanitation”, “Employee training,” “an allergen control program”, “verification procedures” and the dreaded “Other procedures, practices, and processes that the Secretary may deem appropriate . . .” Hmmm – anyone reading this like the sound of this?
There are some other troubling aspects of this proposed legislation that jump off the page at first reading. It is well-crafted for what it appears to be intended to do – allow FDA a far greater degree of control over the food industry (including dietary supplement manufacturing) than has ever been in place before.
After a first read through of the draft legislation the most troubling language involves the concept of a Food Safety Plan and its implementation. The requirement is that BEFORE a facility (foreign or domestic) can introduce a food product into interstate commerce, there must be a Food Safety Plan in place. There are numerous details contained in the legislation concerning what this plan must be and some of those details are redundant to a specific class of foods – namely dietary supplements. Most of the requirements are already spelled out in FDA regulations known as GMPs. So, what’s the beef? Well simply put: Legislation has no business being as finely detailed as this piece of legislation is. If there are challenges with the regulations in place, specifically for GMPs, then Congress should pressure FDA to write appropriate regulations. Oh yeah, I almost forgot – FDA did exactly that with the issuance of 21 CFR Section 111 for dietary supplements. Therefore we should be fine. Well, the problem is that dietary supplements remain a class of food and thus come under the auspices of this legislation every bit as much as a bag of Tostitos.
There is a lot more in this draft legislation and you will find more to learn about it here in this blog posting area.
What is required? Right now – get aware. Get active. Let your trade associations know you are aware of this draft legislation, want to know what they are going to do about it and ask them what they understand it to mean. Then, read as much about the draft legislation as you can. Learn about the ramifications of it from more than just one source (even if that source is your trade association) and get an opinion. Then pressure your trade associations to act on YOUR behalf and in response to YOUR desires. There is a lot more to this than meets the eye – and now is the time to get involved rather than at the 11th hour. More to come.
On May 26, 2009 our friends in Congress (Mr. Waxman and Mr. Dingell specifically) introduced a bit of legislation that is designed to make the public feel safer concerning their food. On the heels of salmonella in spinach and melamine in infant formula, this timely presentation is understandable. Without an extensive reading of the draft legislation this sure sounds like a good idea. The Food Safety Enhancement Act of 2009 (note that the acronym for this is FSEA so very close to DSHEA as to be disconcerting) has a title we can all rally around. Reading the summary as presented also makes it sound good. Well, that’s the intent – to make it all sound good. A little closer look reveals a different agenda among the twists and turns. That agenda includes (and this should come as no surprise to those who watch this sort of thing) introducing additional means of getting after that miscreant industry – the Dietary Supplement Industry. There will be more in-depth discussion of this as it moves along the congressional trail but the sponsorship of the bill and the climate tends to indicate that this one has a good likelihood of getting somewhere. Let’s just look at some of the cursory concerns the Natural Products industry should note and act on first. These bits are lifted from the Summary of the Draft Legislation.
Facilities Registration: No big deal. This proposal is different in that all facilities foreign and domestic are required to register ANNUALLY. This allows for the payment of fees ANNUALLY in order to continue to do business. Still no big deal but there is a requirement for a US agent as primary contact point for the foreign manufacturers. There are ramifications here for that agent if you understand some of the “exporters goods coming to this country. Still, so far seemingly harmless. Unless you look a little closer still. Using materials from a company that is not registered or whose registration has lapsed renders the products that use this material as Adulterated. This would then likely cancel the registration of your facility and everything you made would then become adulterated if it entered the marketplace. Oh yeah – if your facility is suddenly removed from the approved list you have an “informal hearing” setting in which to appeal.
Identifies food safety problems before they occur: Sounds great. An ounce of prevention and all of that. Well if you look a little closer at the text of the proposed legislation you find the implementation via law of a HACCP program for all foods. The evaluation of critical control points in the manufacturing operation will need to be identified and these requirements will apply to foreign manufacturers as well. You will have the burden of assuring these foreign manufacturers meet the standards set up.
Increased Inspection Frequency: The revenues generated from the user fees will be used in part to step up inspection of manufacturing facilities. Have you organized your GMP strategies yet? You might wish to. There is also a tiering of classifications of manufacturers from “low risk” to “high risk.” Wonder where the Natural Products facilities will fall.
Prevention of Food Safety Problems: Who can argue with this? Well a little closer look at the draft legislation reveals that there are some interesting definitions that get incorporated in the Federal Food, Drug and Cosmetic Act that were not there before. It seems that this legislations is crafted to put a tremendous amount of regulatory detail into legislative presentation. Including the subsetting of the importance of adherence to GMPs to a secondary level. Complying with GMPs becomes secondary to the overall term “Preventive Controls.” It is these Preventive Controls that will become the standard for compliance with GMPs being a mere subset along with “Sanitation”, “Employee training,” “an allergen control program”, “verification procedures” and the dreaded “Other procedures, practices, and processes that the Secretary may deem appropriate . . .” Hmmm – anyone reading this like the sound of this?
There are some other troubling aspects of this proposed legislation that jump off the page at first reading. It is well-crafted for what it appears to be intended to do – allow FDA a far greater degree of control over the food industry (including dietary supplement manufacturing) than has ever been in place before.
After a first read through of the draft legislation the most troubling language involves the concept of a Food Safety Plan and its implementation. The requirement is that BEFORE a facility (foreign or domestic) can introduce a food product into interstate commerce, there must be a Food Safety Plan in place. There are numerous details contained in the legislation concerning what this plan must be and some of those details are redundant to a specific class of foods – namely dietary supplements. Most of the requirements are already spelled out in FDA regulations known as GMPs. So, what’s the beef? Well simply put: Legislation has no business being as finely detailed as this piece of legislation is. If there are challenges with the regulations in place, specifically for GMPs, then Congress should pressure FDA to write appropriate regulations. Oh yeah, I almost forgot – FDA did exactly that with the issuance of 21 CFR Section 111 for dietary supplements. Therefore we should be fine. Well, the problem is that dietary supplements remain a class of food and thus come under the auspices of this legislation every bit as much as a bag of Tostitos.
There is a lot more in this draft legislation and you will find more to learn about it here in this blog posting area.
What is required? Right now – get aware. Get active. Let your trade associations know you are aware of this draft legislation, want to know what they are going to do about it and ask them what they understand it to mean. Then, read as much about the draft legislation as you can. Learn about the ramifications of it from more than just one source (even if that source is your trade association) and get an opinion. Then pressure your trade associations to act on YOUR behalf and in response to YOUR desires. There is a lot more to this than meets the eye – and now is the time to get involved rather than at the 11th hour. More to come.
Posted by Jim Lassiter at 5/28/2009 9:34 AM 
Categories: Threats to Industry, FDA and You, Legislation
Tags: Dietary Supplement Law FDA GMP Safety
Categories: Threats to Industry, FDA and You, Legislation
Tags: Dietary Supplement Law FDA GMP Safety
Nice post,
Keep up the good work,
Anyway, thanks for the post
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