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Children’s Hospital of Phil. Concerned About Dietary Supplement Use

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The Children’s Hospital of Philadelphia, referred to as CHOP, has just become the first American hospital to set guidelines for the use of dietary supplements. We know many adults take supplements, but it’s uncertain how many children are being given dietary supplements by their parents. The National Institutes of Health (NIH) estimates “nearly 12 percent of children (about 1 in 9) in the United States are using some form of complementary health product or practice, such as dietary or herbal supplements.”

The doctors and health care practitioners at CHOP found that many parents do not consider dietary supplements to be ‘drugs’ so they fail to report what their children are taking. In many cases the ingredients of these supplements can cause an adverse reaction when combined with certain prescribed medications.

Dietary supplements are unregulated; the F.D.A. can suggest that manufacturers follow “good manufacturing practice” (GMP) conditions but they cannot enforce that recommendation. Ingredients that may be unsafe for adults can be dangerous when taken by children. Earlier this year a Canadian group of scientists studied herbal supplements like St. Johns’ Wort, Echinacea and other popular products. They found that 1/3 of the supplements tested had no trace of the plant ingredient advertised and some contained ingredients that could be potentially unsafe.

According to the New York Times op-ed, Skip The Supplements,  by Paul A Offit, chief of infectious disease, and Sarah Erush, clinical manger in pharmacy department, at the Children’s Hospital of Philadelphia, the hospital is asking more questions of parents. CHOP has established guidelines for administering dietary supplements, requiring “that the manufacturer provides a third-party written guarantee that the product is made under the F.D.A.’s “good manufacturing practice” (GMP) conditions, as well as a Certificate of Analysis (C.O.A.) assuring that what is written on the label is what’s in the bottle.”

“Because vitamins and dietary supplements are essentially unregulated, there is no sound information about adverse side effects, drug interactions, or even standard dosing for the vast majority of them,” said Sarah Erush, Pharmacy Clinical Manager and a member of the hospital’s Therapeutic Standards Committee. “Administering these medications – particularly to children with serious health complications – is unethical when the risks are unknown, and when there are alternative treatments that have been proven in clinical trials to be safe and effective.”

The hospital is contacting dietary supplement manufacturers, in a good faith effort to help parents who feel strongly about giving supplements to their children. But the manufacturers are not showing the same level of commitment to consumer safety. Offit and Erush report that roughly 90% of companies contacted for verification fail to respond. Others have refused to provide the required papers that could authenticate their products. Some lied, claiming they were in compliance with the GMP standards, though the FDA had identified them as being in violation. And, some actually admitted that their products did not meet standards.

The hospital has to take a delicate position in this matter. Parents have the right to give their children supplements. And, the hospital has to do its best to treat illness and prevent unnecessary complications. This new plan provides safeguards for the hospital and ultimately, for patients. The hospital requires parents who insist on continuing dietary supplements to sign a waiver stating that they understand the supplement may be dangerous.  The waiver states, “Use of an agent for which there are no reliable data on toxicity and drug interactions, makes it impossible to adequately monitor the patient’s acute condition or safely administer medications.”

CHOP is the first hospital in the nation to set polices for use of drug supplements. Hopefully this will set a precedent and encourage other medical facilities to adopt similar standards. Until the FDA has the legal authority to regulate the manufacturing process for herbal and dietary supplements it is up to other agencies and individuals to figure out what is safe and what is not. The best course of action for individuals may be to simply eat a more balanced diet and avoid supplements all together.   Given the negative information coming to light over the past several years, this writer has eliminated nearly all supplement intake, fearing either a harmful side-effect or just being taken advantage of by an unscrupulous manufacturer, or both.

 

2 Comments

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  1. Haley Chitty says:
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    This article inaccurately states: “Dietary supplements are unregulated; the F.D.A. can suggest that manufacturers follow ‘good manufacturing practice’ (GMP) conditions but they cannot enforce that recommendation.”

    The truth is that supplements are highly regulated. These regulations include (but are not limited to), a requirement to register with the Food and Drug Administration (FDA). FDA routinely inspects supplement manufacturing operations to confirm compliance with the agency’s current Good Manufacturing Practices (cGMP) for dietary supplements, which is a much more stringent standard than for conventional foods. Both FDA and the Federal Trade Commission (FTC) have authority over product claims and advertising for dietary supplements. In addition, supplement companies must submit to FDA any serious adverse events reported to the company in regard to any of their dietary supplement products.

    Failure to comply with these regulations can result in warning letters, product recalls and criminal prosecution.

  2. James Traub says:
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    The author of this article makes a number of false claims and should be ashamed of continuing to promote mis-information to consumers that might affect their decision to use or not use supplements.

    1. “Dietary supplements are unregulated; the F.D.A. can suggest that manufacturers follow “good manufacturing practice” (GMP) conditions but they cannot enforce that recommendation.”

    This statement is patently false. Dietary supplements are regulated under 21 CFR Part 111 which establishes good manufacturing practices for supplements that are very similar to those established for pharmaceutical drugs. The FDA has numerous enforcement tools at their disposal to use against firms who repeatedly fail to demonstrate compliance with CGMP requirements including fines, seizure of goods, recall and consent decree. In several instances legal action has been taken against the owner/operator of firms unlawfully manufacturing supplement products.

    2. “Until the FDA has the legal authority to regulate the manufacturing process for herbal and dietary supplements it is up to other agencies and individuals to figure out what is safe and what is not.”

    As mentioned above, the FDA DOES have the legal authority to regulate the manufacturing process for supplements. Between 2010 and 2012 FDA conducted 626 inspections of supplement companies (both the total number and the intensity of these inspections continues to increase each year) to assess whether their operations are in compliance with the CGMP regulations. Warning Letters and other actions were taken in response to firms who failed to demonstrate compliance, which is the same manner in which the FDA regulates pharmaceutical drugs.

    I do agree with the author that, at this time, “it is up to other agencies and individuals to figure out what is safe and what is not”. Although there are numerous firms making high-quality supplements, there are many more making products of questionable quality and that do occasionally contain illicit drug substances and unacceptable levels of contaminants. And although the responsibility falls to the consumer to ensure the products they take are safe and efficacious, the consumer unfortunately does not have access to the information required to make this determination. It’s for this very reason that I established my company, SuppFinder.com, to assist with the review and recommendation of supplement products on the basis of product quality.

    3. “The best course of action for individuals may be to simply eat a more balanced diet and avoid supplements all together.”

    This statement is uninformed at best. Many herbal and dietary supplements include extracts or materials not commonly found in the human diet but which have demonstrated health benefit. Avoiding supplements completely is akin to throwing out the baby with the bath water and consumers might lose benefits that could not be made up for with a diet (even a healthy one). Not all health-benefitting substances found in supplements are also found in the human diet, and therefore can not be simply replaced with a better diet.

    Take for example Astaxanthin which one of nature’s most powerful antioxidants and is produced naturally by micro algae. Fish such as salmon and trout (which feed on this algae) contain astaxanthin in very low levels, however studies have shown that amounts ranging from 4 – 8 mg per day are necessary for a variety of benefits. Getting such an amount of astaxanthin from fish (or other natural sources) alone is simply not possible, which is where supplements can be of great use. The same case for can be made for other beneficial compounds found naturally in leaves, roots, flowers, or marine sources.

    4. Finally, in the final paragraph the author chose to use the term ‘drug supplements’, which is a term neither defined nor recognized by the FDA. Products are considered to be ‘drugs’ or ‘dietary supplements’ based on the health claim being made for the product. Given that this article was written to highlight the fact that CHOP is one of the first hospitals to establish policies for supplement use, I would hope that their personnel might first strive to understand the dietary supplement industry and it’s regulations prior to creating policies that might negative impact some of their customers.

    James Traub
    Founder, http://www.suppfinder.com