Why the cGMP is Important to You

Prior to the cGMP (current Good Manufacturing Practices) final rule announced by the Food and Drug Administration (FDA) in July, 2007, the dietary supplement industry had been unregulated since 1994. The new regulations bring more strict control on quality and safety. But some experts say it has nothing to do with the efficacy of the products.

The 50+ year-old dietary supplement company my husband and I use has been in compliance from day one. In fact, they go beyond the rules, because unlike the competition, they guarantee the efficacy-the utmost effectiveness-of their products and their ingredients.

The new rule by the FDA for dietary supplements requires manufacturers to test the purity and composition of their raw materials. Large companies with 500 or more employees had to comply by June, 2008. Small companies with 499 employees or less, by June, 2009, while very small companies with less than 20 employees by June 25, 2010.

The cGMP apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.

“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.

Dietary supplements have been contaminated and sub-potent

In recent years, the supplement industry has been the target of widespread criticism for selling products with contaminated and undeclared ingredients, or with sub-potency. The media has characterized the industry as being largely unregulated.

Since 1994 the FDA has received tens of thousands of voluntary adverse event reports concerning dietary supplements. Many of these were related to misbranding or adulteration, that is, preparing for sale by replacing more valuable with less valuable or inert ingredients. Many others were because of bacteria, glass, pesticides, lead and other heavy metal contamination.

The FDA announced the cGMP is their response to dietary supplement quality problems. Examples of issues the new regulations hope to prevent are:

  1. dietary supplements that contain much more than listed on the label (rarely occurred) and may be harmful
  2. dietary supplements that contain less ingredients than listed on the label (occurred far more likely)
  3. wrong ingredient
  4. drug contaminant
  5. other contaminant (e.g., bacteria, pesticide, glass, lead, foreign material in a dietary supplement container)
  6. improper packaging, and
  7. mislabeled

"This has been a `buyer beware' market," Dr. Mark B. McClellan, the FDA commissioner, said in the announcement, in which he estimated that 1,000 domestic and foreign companies make supplements sold here. "Millions of Americans use dietary supplements every day, and we need to make sure they're getting the products they pay for."

“We’ve known about this problem for a long time,” said Dr. Wallace Sampson, editor of The Scientific Review of Alternative Medicine and a clinical professor of medicine at the Stanford University School of Medicine. “Dosing in these products can vary from 0 percent to 300 percent.”

Are new cGMP guidelines too gentle?

Some are skeptical and concerned that the cGMP raw material testing guidelines are too general — and too gentle:

The Wall Street Journal dated June 23, 2007 said of the cGMP: “Consumer advocates criticized the rules as too lax, saying they don’t specify how manufacturers should carry out the tests or adequately address safety problems posed by some supplements.”

The new regulation “is an example of better late than never,” said Sen. Richard Durbin, an Illinois Democrat. But he said the rules “do not appear to go as far as they could have.”

Dr. Tod Cooperman, president of ConsumerLab.com, a Westchester, N.Y-based company that independently evaluated hundreds of supplements and periodically publishes reviews, says 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 (cGMP new rule) won’t ensure the quality of supplements, but it may help improve the consistency from batch to batch.”

Problem: suppliers of raw materials are exempted from cGMP

“The suppliers of raw materials to the dietary supplement manufacturing facilities are ‘exempted’ from the new FDA cGMPs,” wrote Rick Liva, American Herbal Products Association (AHPA) in its October-November, 2007 newsletter. “Thus, suppliers do not have to follow cGMPs and the burden of quality assurance is on the manufacturer. Not only is this unfair, it is more than highly likely, almost certain, in fact, that a large number of raw material suppliers will simply ignore quality issues (they already do).”

“Many raw materials for dietary supplements come from China and India where sanitation and quality practices are not always what we hope for or would expect. If a dietary supplement manufacturer is buying materials from these countries (lots of them do) and doing no testing whatsoever, what does that mean for you?” If they do test, but use inadequate or economical equipment, how much contamination goes undetected?

In an article entitled “Are Chinese Export Products Unsafe?”, The Wall Street Journal (June 14, 2007) said: “The FDA is responsible for inspecting about 80% of the U.S. food supply (the U.S. Department of Agriculture is responsible for the other 20%, like meat, poultry, and dairy). Despite the on-paper requirement of 80%, in reality the FDA has historically inspected only about 1.7% of the stated 80%. In the past decade, FDA food inspections has decreased to about 1%.”

Large amounts of dietary supplement raw material imported from China

“A huge amount of dietary supplement raw material is imported from China,” Liva continued. “Do you think the FDA will do better with that than with food? Since we can’t trust the FDA to scrutinize it, the assurance of quality must fall upon the manufacturer. But what if the manufacturer doesn’t test properly or stringently enough to assure quality? Who’s going to know?”

China continues to experience contaminated or unsafe supply problems on raw material of all kinds, including pharmaceutical and nutraceutical ingredients of the type that end up in dietary nutritional supplements.

Another Wall Street Journal article (Sept. 20, 2008) entitled “Chinese Tainting Scandal Pulls Milk off Shelves” reported poisoned baby formula killed four infants in China, caused serious kidney problems to at least 158 and sickened at least 6200 others earlier in 2008. This was followed by a second scandal in Sept. 2008 that spread in earnest to milk and other products from some of the country’s biggest and oldest brands.

The Journal article reported: “The spiraling milk crisis raises questions about whether China has made progress improving problems in its often-diffuse and poorly regulated supply chains for foods, pharmaceuticals and other products.”

The article observed: “China’s problems take on added importance because it has become the factory floor for so much of the world—making the vast majority of toys sold in America, as well as clothing and increasingly the raw ingredients that go into pharmaceuticals.”

The following link provides a detailed report, Potential Health & Safety Impacts from Pharmaceuticals and Supplements Containing Chinese-Sourced Raw Ingredients, dated April, 2010, prepared for the U.S. China Economic Review Commission.

Will tainted ingredients be detected by all U.S. companies?

Because the new cGMP do not require specific or standardized tests and leave each manufacturer to decide what is appropriate, the question remains whether detection of ingredient contamination has been answered.

If U.S. manufacturers often rely on tests that aren’t very specific and can be tricked, as Dr. Cooperman said, will all U.S. dietary supplement companies be able to prevent tainted raw ingredients from China and other countries from showing up in U.S. dietary supplements?

An alarming fact: new cGMP doesn't regulate efficacy

While the new FDA regulations on testing bring more strict control on dietary supplement raw material quality and safety, some experts say it has nothing to do with the efficacy of the products, according to an ABC News story, FDA Issues Final Dietary Supplement cGMP Rules, by K.S. Gammon on June 24, 2007, excerpted below:

"These new regulations will at least take the quality issue off the table," says Dr. Brent Bauer, director of the complementary and integrative medicine program at the Mayo Clinic. "If a patient wants to try ginseng, they can be assured that when they purchase a ginseng brand that claims to have 5 percent ginsenosides, they will know that is what they are getting."

The real question is the power to produce an effect of the dietary supplement itself. Though most experts agree that the cGMP regulations will increase the likelihood that supplements will be of high quality, some raise the issue of whether these products -- which claim to remedy everything from decreased sex drive to damaged joints -- actually work.

"Nothing here deals with the question of efficacy, which is a shame," said Dr. Jerry Avorn, Chief of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. "Knowing you have pure and well-made useless crap is a little better than having impure useless crap, but not by much."

The FDA is leaving much of the enforcement of the new regulations to supplement manufacturers themselves, a $24 billion industry. It has recently become law for the supplement industry to report serious health problems associated with their products to the FDA.

The FDA does not require that dietary supplements actually work!

The cGMP does not require that a product actually works! As hard as that is to believe, it's true. A supplement can be marketed without proof whatsoever. Referencing the cGMP, the FDA spelled out its responsibilities on October 6, 2011 in a publication, Dietary Supplements as follows:

"FDA only enforces regulations after an unsafe dietary supplement reaches the market or consumer quality complaints warrant investigation. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements." In other words, consumers are guinea pigs.

Clinical studies to prove efficacy not required for dietary supplements

Even if there is cGMP compliance by all manufacturers, supplements still have fewer controls than drugs -- an important health consideration for the 150 million Americans who take these products. Efficacy is required to market drugs. Double blind placebo controlled clinical studies are a necessity.

"In many countries -- Germany, in particular -- nutrient supplements are regulated like drugs," says Dr. David Katz, director of the Prevention Research Center at Yale University School of Medicine. "The U.S. has lagged behind in that area."

"Most people don't realize that dietary supplements can have side effects, just as there are potential side effects to prescribed medications," says Dr. Nieca Goldberg, medical director of the New York University women's heart program. "Because they are chemicals that are added to your body, I think they should be subjected to the same rigorous evaluation as prescription pharmaceuticals."

Will the new cGMP for dietary supplements be a paper tiger?

Will the cGMP be effective?

"The ruling is appropriate, but it will just be a paper tiger if there is no FDA staff to monitor things," says Keith Ayoob, Associate Professor of Pediatrics at Albert Einstein College of Medicine regarding the new cGMP. "The big pharm companies that do supplements will be compliant. The ones I'm more worried about are the fringe companies that produce nothing but supplements. … If they get caught, they'll just fold up shop and reopen under another name."

A difference: If a drug is suspected by the FDA to be unsafe, the FDA can remove it from the market until the manufacturer demonstrates its safety. For dietary supplements, however, supplements are marketed first, then the onus is on the FDA to prove a product is unsafe before it can be pulled from shelves.

In 2005, after reports of more than 155 deaths were linked to the dietary supplement ephedra, the FDA prohibited its sale. Some experts think that the FDA reacts too slowly when it comes to human safety.

"It would be as if you could learn about car safety through a Consumer Reports subscription, but there were no federal standards for auto safety," said Yale's Katz.

"We really need both -- for cars, and supplements," he said. "For cars, we have both -- but for supplements, until now, we have not. The new FDA ruling narrows the gap."’

So who can you trust for quality assurance?

I believe to find the best supplement brand you must first find the best supplement company.  

To help me find a leader in the dietary supplement industry, I developed 30 questions, slanted towards having a solid science base to comprehensively determine a company’s standards of excellence. In my opinion, it’s the science that separates the field.

The answers led me to a company with a conscience (its motto is the Golden Rule)--The Shaklee Corporation. This is a company that I can trust. They've been the #1 quality assurance leader in the dietary supplement industry for over 50 years.

They lead the industry in raw ingredient testing, conducting 83,000 quality control tests annually to verify the purity and potency of their formulations. Over 1,000 quality control tests are conducted every time their signature multinutrient supplement, Vitalizer, is made. It's the most advanced nutritional supplement in the marketplace today with 80 bio-optimized nutrients, backed by 12 patents, purity, potency and a "feel better in 30 days or your money back" guarantee. No artificial flavors, sweeteners, colors, or preservatives.

For decades, to ensure purity, Shaklee's botanical ingredients go through extensive third party testing far beyond the cGMP, for over 358 potential contaminants, such as herbicides, pesticides, DDT, and heavy metals. Shaklee also tests to verify plant species. They guarantee efficacy, safety and purity for all products they manufacture.

For efficacy, choose a company with the most clinical studies

Efficacy is what you buy a product for in the first place. Yet few dietary supplements have clinical studies on their finished product to prove it actually works! This is amazing to me! This could never happen in the drug industry.

There’s just one natural dietary supplement company, Shaklee, that claims over 90 published studies and abstracts in peer-reviewed scientific journals to support their products’ efficacy. Their research papers have been published in scientific periodicals throughout the world, such as The New England Journal of Medicine, The American Journal of Clinical Nutrition, The Journal of Applied Psychology and the Journal of the American Heart Association.

Independent clinical studies on their products are conducted by researchers at leading universities, including Stanford University, University of California at Davis and the University of Texas.

Paying for testing and studies is quite expensive—which is why Shaklee products cost more than drug store brands. Does your supplement company conduct clinical trials on its products? Ask them. Most do not. If they do, they'll proudly shout about it.

Shaklee makes their own studies available on their website and lists them in their online Featured dietary supplement company you can trust

Isn’t it your goal as a consumer to get what you pay for? You’ll get what you pay for with the company I’m referring to. Each and every product they produce contains precise, effective amounts of active ingredient for optimum health benefits every time. Because of the high quality, I regard the small increase in cost of their products as reasonable; we don’t waste our money!

As Paul Harvey says, “Now you know the rest of the story.”

When it comes to current Good Manufacturing Practices is there anything more important than your health? For over twenty years, I’ve had 100% confidence in Shaklee for my family even before the cGMP dietary supplements final rule.

Because of their high operating standards, they had already met 100% and exceeded 80% of the new cGMP manufacturing regulations when they were announced in 2007. For nutritional health and natural arthritis relief products*, I highly recommend this industry leader.


* CGMP Disclaimer: Health statements on this CGMP page have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease







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