"Washington � Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.
�Finally!� Hatch said. �This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.�
Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing. The GMPs are expected to be published within the next five weeks.
�GMPs are crucial because they assure the public that the products they are buying live up to their labels,� Hatch said. �Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.�"
Yes but they're not government sanctioned in the USA. One of the biggies over here is overseen by a natural supplement trade group called the NNFA.
In Canada, I think they do have a government oversight process - for nutritional supplements. I believe that Natural Factors, a Canadian-based supplement company, manufacturers all their products under CGMP (Canadian Good Manufacturing Practices) rules.
Yes but they're not government sanctioned in the USA.
what do you mean.. "government sanctioned" ?
Quote:
Originally Posted by Harry Hirsute
One of the biggies over here is overseen by a natural supplement trade group called the NNFA.
In Canada, I think they do have a government oversight process - for nutritional supplements. I believe that Natural Factors, a Canadian-based supplement company, manufacturers all their products under CGMP (Canadian Good Manufacturing Practices) rules.
are there any others in the US besides the 3 I mentioned?
I mean that manufacturers that display an NNFA GMP (or an NSF or USP) label don't have any kind of governmental seal of approval - in the US. These are private, not government run organizations.
I know ConsumerLab has a similar quality-seal. There may be others. But those are the only ones that pop to mind at the moment.
I notice that they put up notices of supplements that they had approved of when they passed.. then put in a complaint with the FDA about consumerlabs practices of not posting full test results depending on whether the company had paid or not?
Consumerlabs countersued.. then consumerlabs dropped the suit.. but now I can't find the original complaint on their website or for that matter.. on the FDA website.
FTC Urged to Investigate Purported Consumer Watchdog
2005/01/13 - Council for Responsible Nutrition (CRN)
� Trade Association Petitions Agency to Stop ConsumerLab.com�s Deceptive Business Practices �
WASHINGTON, D.C., January 13, 2005 � The Council for Responsible Nutrition (CRN) has asked the Federal Trade Commission (FTC) to investigate deceptive business practices by ConsumerLab.com and take appropriate action.
The CRN complaint states that ConsumerLab.com�which represents itself as a consumer watchdog testing dietary supplements�is in reality a for-profit company that solicits money from the makers of products it plans to have tested. Those that pay have positive results highlighted and negative results quashed; those that don�t pay have negative results highlighted and positive results obscured.
"Until now, nobody has looked behind the curtain and exposed ConsumerLab.com�s tactics," said CRN President Annette Dickinson, Ph.D. "It is a business, not a watchdog�one that intimidates manufacturers to pay for its services. We ask the FTC to lift the veil this company uses to disguise its true nature."
ConsumerLab.com promotes itself as "a leading provider of consumer information and independent evaluations of products that affect health and nutrition." Contrary to the image it projects of an actual testing facility, ConsumerLab.com essentially is a three-person operation, and its business address is a UPS drop box in White Plains, N.Y. It farms out product testing, but does not make public the identity of the laboratories it uses.
Here is how it works: ConsumerLab.com approaches dietary supplement makers requesting that they enroll in its "voluntary" testing program�for a fee. Those that pay are guaranteed that products failing the subsequent testing will not be identified publicly. Companies that do not pay risk having their products tested anyway and, if they fail, being publicized on ConsumerLab.com�s Web site and in the media.
Meeting ConsumerLab.com�s standards is no guarantee that a manufacturer will be treated fairly. Only products from companies that pay up and pass are mentioned on the free portion of ConsumerLab.com�s Web site. Products that pass but are made by companies that don�t pay are listed only on the private portion of the site. These products are absent from the public site, giving the impression to non-subscribers that they must have failed because they aren�t listed. And even the 20,000 Web subscribers, who pay $24 a year for "full access" to product tests, aren�t told that ConsumerLab.com has agreed to suppress failing results for companies that paid up.
CRN and its member companies recognize the value and importance of legitimate third-party testing programs�such as those run by U.S. Pharmacopeia and NSF International�that operate in an honest and aboveboard manner and help consumers select high-quality products. The ConsumerLab.com business model, by contrast, is unfair and deceptive.
CRN is asking the FTC to make ConsumerLab.com: 1) make public all future test results regardless of whether companies have paid money to ConsumerLab.com; 2) release testing criteria and methodologies in advance; 3) identify the contract laboratories that actually do its testing; and 4) change its name to one that does not falsely imply that it does its own testing.
"ConsumerLab.com�s entire business model is based upon threat and deception," Dr. Dickinson said. "Forcing it to come clean will take away its ability to mislead the media and the public."
Founded in 1973, CRN is a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices. For more information on CRN, visit www.crnusa.org.
A copy of CRN�s FTC complaint is at: Council for Responsible Nutrition-The Science Behind the Supplements
Contact:
Judy Blatman
202-204-7962
The original copy of the complaint was here (but no more): https://[URL="https://www.crnusa.org/PR05_0113_FTC.html"]www.crnusa.org/PR05_0113_FTC.html[/URL]
CRN is another trade organization (like the NNFA). So, you have to factor that into the equation. I think they do some good. But they're primary purpose is to protect the interests of the industry that they represent.
I used to know more about the circumstances surrounding the feud. I think there was a long thread about this on the "other" forum.
Here's a summary I found in a trade publication:
Quote:
ConsumerLab.com has dropped its lawsuit against the Council for Responsible Nutrition, both groups announced last week.
The suit originated after CRN asked the Federal Trade Commission in January 2005 to investigate ConsumerLab.com's business practices. ConsumerLab.com tests vitamins and supplements; companies that pay for testing are guaranteed to have positive results posted on the free section of the White Plains, N.Y., company's Web site, while negative results are not mentioned. Meanwhile, companies that do not pay the $3,750 fee risk having negative results published, and any positive results are posted on the subscription-only area of the Web site, according to the complaint.
In its letter to the FTC and the media, CRN described these practices as "unfair and deceptive," and said the business model "intimidates manufacturers to pay for its services." CRN is a Washington, D.C., based trade association that represents ingredient suppliers and manufacturers of dietary supplements.
In March 2005, the FTC refused to take action on CRN's complaint, and the following month, ConsumerLab.com filed suit, claiming that CRN's letter defamed the company. CRN sought to have the case dismissed but a New York Supreme Court denied the motion.
According to a published statement by CRN, "All but one of ConsumerLab.com's claims in the lawsuit were dismissed by the court earlier this year. Today's voluntary filing vindicates CRN by dismissing the final count of ConsumerLab.com's lawsuit."
The trade group also noted that "ConsumerLab.com … received no money from CRN and no retraction of any kind in return for dropping the case. ConsumerLab.com dropped its lawsuit as CRN was about to ask the court to require ConsumerLab.com to produce additional information and documents about its business practices."
ConsumerLab.com had a different take on the final outcome. "CRN's legal tactics had forced ConsumerLab to divert an extraordinary amount of resources to the case. … For practical purposes, ConsumerLab's position was already vindicated when the FTC found no reason to take action with respect to CRN's complaint," the company said in a statement.
"It was clear that continuing at full steam to test our products and publish our reports for consumers was more important than eventually winning this case. We could not let CRN slow us down. We chose to drop the case."
Neither company seems ready to concede to the other, however. Steve Mister, president and chief executive of CRN, said "We were prepared to see through the litigation. We had concerns to begin with and we still have concerns," though he declined to say what the group's next step might be.
Mister emphasized that CRN supports independent certification and testing programs, such as those offered by U.S. Pharmacopeia and NSF International. "They're good for consumers because they provide confidence in the products … and they're good for industry because they level the playing field," he said.
But he said ConsumerLab's practices "play both sides of the aisle," taking money "from the industry on the one hand, and on the other they take money from consumers who are buying these test results. But they don't get to see everything, and that does a disservice to the consumer."
Tod Cooperman, president of ConsumerLab, defended his company's practices, saying its voluntary certification program "is no different than the ones that [CRN officials] endorse, that their members offer, where companies come to them and pay a fee."
Cooperman said the voluntary certification program is distinct from its independent product reviews. "[CRN] tried to make it sound as if a company could pay us off in our independent product reviews, which is certainly not the case."
hmmmm... I notice the consumerlabs does not really deny the allegations.. do they? They just say they do what other businesses do.
hmmmm....
dang.. someone needs to start a "consumer reports" for supplements. just charge for the magazine that publishes the results. Make it a policy to take no money (in advertising, etc) from any company. and just randomly test a few products every week, and publish the results.
Their costs would be less than consumer reports because they would only have one kind of testing (as opposed to testing cars/refrigerators/lawn mowers/etc.)
hey.. maybe a group of us should write consumer reports.. say we don't want a report on the "best vitamin", but just a report on whether the supplement delivers what it promises on the bottle.
The GMPs Are Coming! The GMPs Are Coming!
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