FDA drops the hammer. laws to go into effect asap

[Outside Backer]

Dietary supplements face stricter regulations
For first time, companies must test products for contamination, FDA says
By Julia Sommerfeld
Senior Health Editor
MSNBC
Updated: 2:08 p.m. ET June 22, 2007
For the first time, makers of dietary supplements, including vitamins and herbal pills, will be required to test their products, the Food and Drug Administration said Friday.

Under the Dietary Supplement Health and Education Act, which passed in 1994, supplement makers were told they must be able to substantiate the safety of their ingredients. Now, 13 years later, the FDA's announcement represents the actualization of that requirement.

The agency is phasing in the new rule requiring supplement makers to test the purity and composition of their products. Big companies will have to comply by next June, while small companies have until 2010 to start testing their products.

?This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,? FDA Commissioner Andrew von Eschenbach said in a statement.

If the FDA discovers that supplements do not contain the ingredients they claim to contain, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove the ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges. The FDA has also announced requirements for record keeping and handling consumer complaints.

Some are skeptical and concerned that the guidelines are too general ? and too gentle.

Dr. Tod Cooperman, president of ConsumerLab.com, a Westchester, N.Y.-based company that independently evaluates hundreds of supplements and periodically publishes reviews, says the the new standards leave too many important decisions to the manufacturers, such as which type of testing methods are appropriate.

"The problem is manufacturers often rely on tests that aren't very specific and can be tricked," Cooperman said. His lab has found instances of lead contamination and wrong ingredients that manufacturers' own testing methods have not identified. "This won't ensure the quality of supplements, but it may help improve the consistency from batch to batch."

The new rules don't ask companies to do testing to prove any of their health claims. Still, this announcement is largely seen as a step in the right direction.

"Supplements have been an exempt industry, so this is a shift that's important and overdue," said Art Caplan, director of the University of Pennsylvania's Center for Bioethics and an MSNBC.com columnist. "It's not the most vigorous approach but it's better than nothing."


Last year, the FDA found that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that didn?t contain the levels of vitamin C or vitamin A that were claimed.

Most companies already test their raw ingredients once they come into the plant, said Steve Mister, president and CEO for the Council for Responsible Nutrition, a trade association representing about 65 manufacturers.

?This raises the bar so that all have to comply,? Mister said.

Dietary supplements ? pills, liquids or other products people take to improve their diets ? are a $22 billion industry.
__________________

 

[Outside Backer]

FOR IMMEDIATE RELEASE
June 22, 2007
Media Inquiries:
Michael Herndon
Kimberly Rawlings
301-827-6242
Consumer Inquiries:
888-INFO-FDA



FDA Issues Dietary Supplements Final Rule
The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.

Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html

Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html

To see a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," visit http://www.fda.gov/consumer/updates/...pps062207.html.




http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

 

[bulls**t]

If implemented correctly, this could be a good thing for the industry. But that is a big if.

 

[mattikus]

If implemented correctly, this could be a good thing for the industry. But that is a big if.

True dat. So what exactly does this mean for the industry? How do the FDA plan on enforcing this? I imagine that this will be the end of all non DSHEA compliant supplements. Good or bad, some companies are probably going down.

 

[djl]

I see this being mired down in so much beauracracy that it becomes nothing more than a bullet point in a politician's reelection campaign.

Think of all of the companies making this stuff. What'd it say, a $22 BILLION dollar industry? Skids will be greased, companies will be overlooked due to shear quantity that the gov will have to keep track of.

But it sure looks good on paper. Best of intentions, and all that.

 

[yeahright]

Probably a good thing. Like most govt regulation it will only be spot enforced but if penalties are high enough for noncompliance, then most companies will do it.

 

[djbombsquad]

Sweeeet. I know some of the products I have bought in the past was on back order for 2 years because the raw martial had fungus from the supplier. They keeped looking for new suppliers apparently and nothing for 2 years so I was out of a specific product. Good job FDA.

 

[yeahright]

Sweeeet. I know some of the products I have bought in the past was on back order for 2 years because the raw martial had fungus from the supplier. They keeped looking for new suppliers apparently and nothing for 2 years so I was out of a specific product. Good job FDA.

It's the companies that would cap and sell the contaminated product that we all need to worry about.

 

[jmh80]

Damn - now overdosed test boosters will get a company in trouble.



In theory - this should work - however I'm VERY nervous the FDA will use this to pull products off the market. God only knows what all they could pull.
But - I have in the back of my mind that something like Powerfull or Rebound Reloaded will be gone.

 

[slow-mun]

This is a double edged sword. They make laws like this to give absolute power to a government agency without appearing to be actually doing just that. The upside to this is that consumers will have their dietary supplements regulated, which makes them guaranteed the safest product. Is there a single instance that brought this about? I'm sure tainted dog food and toothpaste within the last couple of months didn't help, but there's no direction to wholeheartedly point the finger at. Honestly, small companies will disappear, product prices will increase, proprietary blend products will be gone, and "Big Pharma" is going to have the last laugh. Those of you who think this is all gravy will be singing a different tune very shortly.

 

[ShakesAllDay]

Council for Responsible Nutrition, a trade association representing about 65 manufacturers

You would think that organizations as such would already keep this type of stuff in check. Who's worse? The street gang-banger or the kingpin?

 

[djbombsquad]

That is why there is the gmp standards etc double blinded placebo studies, peer reviewed.

 

[bioman]

Here's the American Botanical Council's take on the ruling....


FDA Publishes Final Rules for Good Manufacturing Practices for Dietary Supplements

(Austin, TX.) June 22, 2007. The US Food and Drug Administration (FDA) announced today that it has published final regulations for Good Manufacturing Practices (GMPs) for dietary supplements. In a conference call with members of the dietary supplement industry, consumer groups, academic organizations and other stakeholders, officials of the FDA explained the publication of the long-awaited final rules.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, PhD, director of FDA's Center for Food Safety and Applied Nutrition, in a press release distributed by the FDA just after the conference call.

"This is a long-awaited and welcome development," said Mark Blumenthal, Founder and Executive Director of the American Botanical Council, an independent, nonprofit, science education organization dealing with herbs and herbal products in Austin, Texas.

"It has been 13 years since Congress authorized the FDA to produce more stringent GMPs to help ensure the proper identity, purity, and content of dietary supplement products," Blumenthal added. "This is a significant day for consumers and health professionals who use these natural products for their health. It will result in their having more confidence in these products and their potential benefits," he noted. "It is also an important event for the industry, the responsible members of which have been pushing for these rules for many years."

In general, GMPs, also referred to as current Good Manufacturing Practices (cGMPs), specify all the methods and processes necessary to ensure proper processing, manufacture, labeling, and storage of food and drug ingredients and finished products. Dietary supplements (like
vitamins, minerals, herbs, and other ingredients) are technically classified as foods, not drugs, under federal law. The Dietary Supplement Health and Education Act of 1994 (DSHEA) authorized the FDA to promulgate new GMPs for the processing, manufacture, labeling and storage of ingredients for dietary supplements as well as the finished dietary supplement products. Such dietary supplement GMPs were to be modeled on GMPs required for foods, not the more stringent GMP requirements of drugs.

Since 1994 many members of the dietary supplement industry have urged the FDA to publish GMPs for dietary supplements. In 1997 a group of industry trade associations collectively and voluntarily submitted to FDA some proposed GMPs for the agency's consideration in formulating the GMPs. In 2003 FDA published draft GMPs for public comment, but these were not finalized and published until today. During the intervening years, FDA has received considerable pressure from industry, Congress, consumer groups and the media to publish the final GMP rules for dietary supplements. During all this time, dietary supplement manufacturers have had to comply with GMPs designed for processors and manufacturers of conventional foods, which deal primarily with issues related to proper sanitation. The new GMPs for supplements and their ingredients will require more detailed rules and procedures regarding testing of raw materials as well as finished goods to help ensure proper identity, purity, etc.

The FDA stated today that the final GMP regulation and another interim final rule (see below) are effective August 24, 2007. The new rules will take up to three years to go into effect, depending on the size of the company. Large companies (more than 500 employees) will have to comply with the rules within one year (June 2008), while medium-sized companies (less than 500 employees) will have two years (June 2009), and small companies (less than 20 employees) will have up to three years (June 2010) to meet the new requirement.

"The new rules will probably have minimal impact on many responsible and foresighted manufacturers of herbs and other dietary supplements," noted ABC's Blumenthal. "These companies, anticipating the eventual publication of these new rules, have invested millions of dollars over the past decade in creating in-house laboratories and hiring the qualified technical personnel needed for testing the ingredients and the final products produced in their facilities. Many have also instituted newly-enhanced procedures and record-keeping necessary for ensuring product quality the kinds of procedures that are presumably being required or suggested in the FDA's new rules."

As part of its nonprofit educational mission, ABC recently published a handbook for use in quality control laboratories to help ensure that manufacturers can properly identify botanical raw materials before they are subjected to processing into herbal teas, dietary supplements, cosmetics or other products. The new book, The Identification of Medicinal Plants: A Handbook of the Morphology of Botanicals in Commerce by botanist Wendy Applequist, PhD, was produced in cooperation with the Missouri Botanical Garden in St. Louis, one of the world's leading botanical research institutions. It is available on the ABC website, at: http://abc.herbalgram.org/site/R?i=5liTFJNTzwmzpmNbiu-vzA..

Along with the new GMPs, the FDA also published a companion document, an interim final rule outlining a petition process for manufacturers to request an exemption to the GMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements. According to the FDA press release issued today, under this interim final rule "the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007." (Comments on this interim rule may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.)

The FDA posted a press release on its website at about 11:30 am EDT today explaining its new rules. The release can be accessed at http://abc.herbalgram.org/site/R?i=ZwXC792vdg7aCqg5_dLY0w.. The FDA also published a backgrounder document http://abc.herbalgram.org/site/R?i=wSEjrWgNWdU0h1c3vOSMJg.. ) and a "Fact Sheet" dealing with the new GMPs: http://abc.herbalgram.org/site/R?i=OoTfaIUH6eDJggmVY0OcRg.. The agency also has published a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," available at http://abc.herbalgram.org/site/R?i=bRF5XU20OXRzZ49due9agw..

The final rule, which will be published in the Federal Register on June 25, 2007, may be viewed online in advance at http://abc.herbalgram.org/site/R?i=r4S4cnO6qUH0WHKDpSPJUw.. An advance copy of
the interim final rule is available at: http://abc.herbalgram.org/site/R?i=YRWM62XkAmSmcdcw9UHx5g..

 

[Rx Lift]

This law primarily effects contract manufacturers. The only thing that finished product retailers have to worry about is paying a price increase on having there products made, and a longer turn around time. If the company is already using a cGMP manufacturer, then nothing changes. The only companies that will be going out of business are the garage encapsulators which run a ****ty operation as is, and dont have anywhere near the overhead to rebuild there garage as a cGMP manufacturing faciltiy. Now Applied Nutraceuticals, how do you guys plan on dealing with this? Since you manufacturer your products in house, are you planning on switching over to a cGMP contract manufacturer?

 

[Viperspit]

I think this is a great effort. It will be interesting to see how it plays out though. The FDA has a hell of a lot larger issues that need to be dealt with currently (CHINA), but we will see where this falls on their priority list.

The Proprietary Blend issue is a double edged sword. This is both protection for the stand up companies that do not want their product ripped off withiin weeks after it hits the market, but it's also a shelter for other what some refer to as shady companies. I do find it humorus that you will see companies on various boards crying about the use of prop blends, then you turn around and look at their products and what do you see? yep, prop blends. So, we can't always have it the way we want in this world, it looks like the Government may decide for us. As a wise woman once said, this ain't Burger King baby

 

[Outside Backer]

<--- no worries here at applied we already follow these standards

 

[Vitruvian]

I am in a way glad to see this happen. While it may be a dangerous thing to openly state, I think "they" are already all over it, so no fears that I am giving them new ideas. In domestic preparedness and homeland security, we learn a lot about the various vulnerabiltieies to our nation. My #1 fear is the food system. My #2 fear: the supplement industry.
Anyone on the inside knows how easily it could be done..............

 

[rms80]

This law primarily effects contract manufacturers. The only thing that finished product retailers have to worry about is paying a price increase on having there products made, and a longer turn around time. If the company is already using a cGMP manufacturer, then nothing changes. The only companies that will be going out of business are the garage encapsulators which run a ****ty operation as is, and dont have anywhere near the overhead to rebuild there garage as a cGMP manufacturing faciltiy. Now Applied Nutraceuticals, how do you guys plan on dealing with this? Since you manufacturer your products in house, are you planning on switching over to a cGMP contract manufacturer?

It will effect the companies (larger contract manufacturers) with over 500 employees the most- there was a plant in Fort Mill, SC that did contract manufacture that voluntarily shut down last week- they could not afford to implement all the changes required in the allotted August 2007 time frame- so they closed their entire East Coast operation.

How will AN adapt? Pretty easily, actually- the law really changes very little for us, since we do everything by the book anyways AN is in the process of getting ISO and cGMP certifications (and will have the certification in the alotted FDA-mandated time frame), and strictly adheres to all GMPs- it is actually easier to stick to GMPs in a smaller operation, for the following reasons:

1. The chain of custody of raw and finished goods is much shorter- a lot of mistakes and issues can arise from this in itself

2. You can hand-pick your own suppliers of raw materials and develop business relationships personally instead of through said contract manufacturer

3. Process documentation is much easier to keep track of, because you are seeing how each process is implemented, and how it applies to the products of our company

4. You control and write your own SOPs and Quality Assurance Manual, and I (as the QAP) am in charge of dictating all these processes to employees (HUGE). These are tailored the needs of AN and our customers, and how we can bring you, the consumer, a safer, more effective product (not 50-100 other companies)- this makes for better quality control, process documentation, employee training, and employee awareness of cGMPs...

5. Most importantly, we reserve the ability to bring AN customers THE VERY BEST extracts and products, because we are not paying a contract manufacturer extra $$$ to make our products for us.

Products that would cost most companies an arm and a leg to bring to market and would not be cost effective ARE cost effective to AN, and this allows us to bring out the most effective products on the market, and we pass these savings on to our customers. We roll the money we save back into two things: better equipment and better ingredients/extracts. The result: RPM, IGF-2, NeoVar and the rest of our product line!!!

We are in this game to be a profitable company, just like everyone else, but we (ME especially) take a LARGE amount of pride in what I manufacture, and it is reflected in all of AN's products!!!

6. The same people are making YOUR products day-in and day-out w/ the same formulations and processes (not the products of 50-100 different companies- this is where mistakes really come into play). This also prevents cross-contamination issues....

7. You can design your own manufacturing facility, and taking into account FDA/cGMP guidelines, tailor it to the needs of your company and customers.

8. We have a 700 square-foot in-house manufacturing facility that is strictly humidity-controlled (less than 25% at all times), air quality-controlled (air flitration down to 0.5 microns), and temperature-controlled (78 F at all times). The facility is complete with separate linear rooms for mixing, encapsulation, and bottling. We based the design of this facility off of FDA/cGMP guidelines- we know exactly what was expected of us when we built the facility, and did not deviate from it.

9. Direct product sampling/lot retention/batch management is MUCH easier, and required testing can occur within a day because we keep all lot and batch records in-house. Stability testing is easier for this reason as well- we know EXACTLY when someone was made, not a general idea, and we have all of the COAs and refs to back it up....


10. We have the ability to formulate, research, and test numerous different supplement combinations in a controlled environment- we have 100 different types of raw materials in our warehouse, and AN is constantly researching ways to make our products better, and how to make more effective combinations/blends.

11. We clearly list all product components of our blends on the label, and this is strictly adhered to- we don't make up names for novel components, and won't produce anything that has not been deemed safe and effective by research- in a smaller operation run by honest people, this is a very easy process to adhere to.

Just because we are small does not mean we are not highly organized- hell, ask Outside Backer or Buffhunk- they have both seen our entire operation

 

[rms80]

PS- we are in the finishing stages of having our products approved for sale in Canada by NHP- they are pretty strict about everything (much more so than the US), and it is a fairly lengthy approval process- and we would not be able to do this w/o sound cGMP/Quality Assurance protocols in place

 

[texxlnghorn]

Blah, blah, blah

It doesnt really mean anything in the big picture.

Youll still have companies like the one that makes lipodrene put viagra in their male enhancement.

 

[slow-mun]

Blah, blah, blah

It doesnt really mean anything in the big picture.

Youll still have companies like the one that makes lipodrene put viagra in their male enhancement.

:wtf:

 

[V00D00]

This is a double edged sword. They make laws like this to give absolute power to a government agency without appearing to be actually doing just that. The upside to this is that consumers will have their dietary supplements regulated, which makes them guaranteed the safest product. Is there a single instance that brought this about? I'm sure tainted dog food and toothpaste within the last couple of months didn't help, but there's no direction to wholeheartedly point the finger at. Honestly, small companies will disappear, product prices will increase, proprietary blend products will be gone, and "Big Pharma" is going to have the last laugh. Those of you who think this is all gravy will be singing a different tune very shortly.

agree agree agree

 

[Vitruvian]

It will effect the companies (larger contract manufacturers) with over 500 employees the most- there was a plant in Fort Mill, SC that did contract manufacture that voluntarily shut down last week- they could not afford to implement all the changes required in the allotted August 2007 time frame- so they closed their entire East Coast operation.

How will AN adapt? Pretty easily, actually- the law really changes very little for us, since we do everything by the book anyways AN is in the process of getting ISO and cGMP certifications (and will have the certification in the alotted FDA-mandated time frame), and strictly adheres to all GMPs- it is actually easier to stick to GMPs in a smaller operation, for the following reasons:

1. The chain of custody of raw and finished goods is much shorter- a lot of mistakes and issues can arise from this in itself

2. You can hand-pick your own suppliers of raw materials and develop business relationships personally instead of through said contract manufacturer

3. Process documentation is much easier to keep track of, because you are seeing how each process is implemented, and how it applies to the products of our company

4. You control and write your own SOPs and Quality Assurance Manual, and I (as the QAP) am in charge of dictating all these processes to employees (HUGE). These are tailored the needs of AN and our customers, and how we can bring you, the consumer, a safer, more effective product (not 50-100 other companies)- this makes for better quality control, process documentation, employee training, and employee awareness of cGMPs...

5. Most importantly, we reserve the ability to bring AN customers THE VERY BEST extracts and products, because we are not paying a contract manufacturer extra $$$ to make our products for us.

Products that would cost most companies an arm and a leg to bring to market and would not be cost effective ARE cost effective to AN, and this allows us to bring out the most effective products on the market, and we pass these savings on to our customers. We roll the money we save back into two things: better equipment and better ingredients/extracts. The result: RPM, IGF-2, NeoVar and the rest of our product line!!!

We are in this game to be a profitable company, just like everyone else, but we (ME especially) take a LARGE amount of pride in what I manufacture, and it is reflected in all of AN's products!!!

6. The same people are making YOUR products day-in and day-out w/ the same formulations and processes (not the products of 50-100 different companies- this is where mistakes really come into play). This also prevents cross-contamination issues....

7. You can design your own manufacturing facility, and taking into account FDA/cGMP guidelines, tailor it to the needs of your company and customers.

8. We have a 700 square-foot in-house manufacturing facility that is strictly humidity-controlled (less than 25% at all times), air quality-controlled (air flitration down to 0.5 microns), and temperature-controlled (78 F at all times). The facility is complete with separate linear rooms for mixing, encapsulation, and bottling. We based the design of this facility off of FDA/cGMP guidelines- we know exactly what was expected of us when we built the facility, and did not deviate from it.

9. Direct product sampling/lot retention/batch management is MUCH easier, and required testing can occur within a day because we keep all lot and batch records in-house. Stability testing is easier for this reason as well- we know EXACTLY when someone was made, not a general idea, and we have all of the COAs and refs to back it up....


10. We have the ability to formulate, research, and test numerous different supplement combinations in a controlled environment- we have 100 different types of raw materials in our warehouse, and AN is constantly researching ways to make our products better, and how to make more effective combinations/blends.

11. We clearly list all product components of our blends on the label, and this is strictly adhered to- we don't make up names for novel components, and won't produce anything that has not been deemed safe and effective by research- in a smaller operation run by honest people, this is a very easy process to adhere to.

Just because we are small does not mean we are not highly organized- hell, ask Outside Backer or Buffhunk- they have both seen our entire operation

Dirk plagiarized this answer telepathically from my mind. :dump: