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Global Evolutions

Editorial Wrongly Tells Consumers to 'Skip the Supplements'

Even though the supplement industry has worked hard this year on educating companies on GMP compliance and reducing illegal health claims, we got a lump of coal from Santa in terms of a couple of negative studies and bad consumer media press.

The Annals of Internal Medicine gave a quadruple whammy with three stories and editorial, all shining a negative light on supplements' efficacy. Read INSIDER's news on this here.

The New York Times also took its jab at supplements in an editorial written by Paul A. Offit, M.D., chief of the division of infectious diseases at the Childrens Hospital of Philadelphia (CHOP, yes, the author of the book that slams alternative medicine), and Sarah Erush, PharmD, BCPS , clinical manager in the pharmacy department at CHOP.  They encouraged consumers to "Skip the Supplements," an explained CHOP's policy doesn't allow supplements for children in their hospital unless documents show the products are GMP (good manufacturing practice) compliant or provide a certificate of analysis (CoA).

Still, if patients want to continue supplement use, CHOP makes the parents sign waivers that the supplements may be dangerous and ineffective.

We've reported on CHOP's decision to is remove most dietary supplements from it formulary due to the incorrect notion that "vitamins and dietary supplements are essentially unregulated," according to Erush. (We also reported on the supplement industry's reaction.)

Proof of Compliance

In this current opinion piece, Dr. Offit and Erush say they are willing to give patients supplements as long as the manufacturers can provide CoAs of the finished products or a certificate of GMP  compliance. They wrote that although some supplement companies have provided this information, about 90 percent of the companies didn't respond, and others refused to provide a CoA or proof of GMP compliance.

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said the trade organization isn't aware of any companies that refused to give information to CHOP.

Also at issue is what CHOP means by "certificate of analysis." Mister said its idea of a CoA is likely different from the way the supplement industry means CoA, which is a document that shows tests run and test results of raw materials. He said perhaps CHOP is looking for finished supplement lab results, and "GMPs require companies to do finished product testing to demonstrate that what's in the bottle is in the label," he said. "I can't image a member company of CRN would not give that to a hospital that was asking for it."

Wrong About Fines for GMP Violations

The editorial says some companies lied to them by saying they were GMP compliant, "but a call to the FDA revealed they had been fined for violations multiple times." FDA may issue warning letters, but it doesn't issue fines for GMP noncompliance.

Mister saida far as he's  aware, no companies have received fines for their GMP violations. "It makes me suspect to the veracity of the rest of the article because they get the regulation wrong."

Even if they did get it right and said these companies were warned for GMP violations, one warning letter or Form 483 doesn't mean a company is forever out of compliance with GMPs. FDA issues warning letters so companies can make corrections, and the agency demands to see those corrections were implemented. It's a way of ensuring products are safe.  

Overages or Lies?

Dr. Offit and Erush said other supplement companies provided information that showed products were out of spec, such as supplement with almost twice the amount of beta carotene on the label.

Without seeing documentation, Mister couldn't comment on this case specifically, but he noted overages are allowed for supplements to ensure they meet label claims at the end of the shelf life. It is the nature of natural ingredients to deteriorate after production. "It is not unusual for products to have an overage at the beginning of their shelf life with the understanding that it will deteriorate, and after three or four months, you would still meet label claims," Mister said. "The case that he describes in his article, if it's true, sounds like a really excessive difference."

Further, Mister noted, "If the Children's Hospital has information that supplements are grossly misrepresented, that information should be turned over to FDA immediately for enforcement."

Supplement Secrecy

Dr. Offit and Erush also complained that hospital patients often don't tell their doctors of the supplements they are taking. The supplement industry has never told consumers not to tell doctors of their supplement use and in fact, this new policy may be harming the relationship between patients and health care providers.  

"This guest editorial piece furthers a policy that shuts down the conversation between consumers and their health care providers," Mister said. "It pushes people into secrecy, and just the opposite should be happening. People should be encouraged to have honest, open dialogues with their health care providers about the supplements they are using, and not pushed into the underground because the hospital takes this one-sided approach that all supplements are bad."

Shifting Policy

CHOP's actual policy, which CRN obtained, is different from the rules described by Dr. Offit and Erush, according to Mister. "The thing that strikes us most is the shifting nature of the policy," Mister said. "The supplement policy, as it was described in the October press release is different than the policy described by Dr. Offit in the New York Times, which is different from what the policy actually says."

Mister said CHOP's policy, which was obtained weeks after it was requested, is not a ban on all supplements in the hospital, which was how it was promoted in the press release in October. "It is in fact giving patients one side of the story of the safety of these products to try to discourage them from using it," he said.

CRN is preparing a full response to CHOP.

Reasons Behind CHOP's Policy

Dr. Offit and Erush noted hospitals treat supplements like drugs because they offer  pharmacological effects; they said,  "they are drugs." They continue by saying supplements arent safe, pointing out four cases of adulteration.

They point to a 2004 JAMA study that found up to 20 percent of Ayurvedic herbal medicine products bought in Boston (made in South Asia) were found to contain potentially unsafe levels of heavy metals (JAMA; 292, 23:2868-73, 2004). At the time, the American Botanical Council (ABC) and American Herbal Products Association (AHPA) both said the products were not supplements, but were adulterated under DSHEA. Further, Mark Blumenthal, ABC's executive director, noted the implementation of federal GMPs (good manufacturing practices) for dietary supplements would have helped prevent these types of problems. GMPs weren't enforced by FDA until 2010.

In another pre-GMP enforcement case, Dr. Offit and Erush called to  a 2008 case of products spiked with way too much selenium that led to hair loss, muscle cramps, diarrhea and other problems. This case was due to a calculation error and a series of testing mistakes. Again, this was before federal GMPs were implemented.

 Then, they noted two products spiked with steroids that were recalled in July 2013. Lastly, they mentioned a study that reported many botanical products are adulterated.

I'm not making excuses for these incidents, nor am I saying they aren't serious (except for the botanical study, which may not be accurate due to imprecise evaluation methods). It's a terrible thing when products sold as supplements are dangerous, illegal or ineffective. And industry has taken steps to reduce these instances by offering education and other resources on GMP compliance.

It's inappropriate to use these four cases during the past 10 years to conclude that consumers should skip supplements. Thousands of studies show the benefits to supplements, if they are used appropriately.

These cases actually demonstrate how current regulations enforced by FDA keep dangerous products off the market, according to Michael McGuffin, president of AHPA, who wrote a letter to The New York Times criticizing the article. "The authors suggest that supplements be regulated like drugs," McGuffin wrote. "But these products are not drugs and should not be regulated as drugs."

McGuffin also noted the authors' notion that  approximately 50,000 adverse reactions to dietary supplements occur every year was flawed and outdated because it was extrapolated from drug and vaccine adverse event reports (AERs). The drug AERs used as the basis for the supplement AER data was  gathered from 1994 to 1999, which was before the 2006 law that requires serious supplement AERs to be submitted to FDA.  McGuffin said FDA estimates 8,000 serious AERs for supplements each year, compared to 499,000 for drugs and therapeutic biologic products

"The authors also ignore the fact that submission of an adverse event report to FDA is not considered to be evidence of a cause-and-effect relationship between the product used and the reported event," McGuffin wrote to The New York Times.

With flawed stats, inaccurate legal information and a one-sided approach, Dr. Offit and Erush told consumer to "Skip the Supplements." I suspect the real message Dr. Offit was saying was, "buy my book."

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