I am asked quite frequently to evaluate supplements cases and thought I would share some information that I have found to be helpful and provide some things to consider.

The following supplements can be very dangerous and I recommend they be avoided. Supplements, which combine these and other ingredients into multi-ingredient supplements, are even worse.

• Aconite
• Bitter Orange
• Chaparral
• Collodial Silver
• Coltsfoot
• Comfrey
• Country Mallow
• Germanium
• Greater Celandine
• Kava
• Lobelia
• Yohmbe

From a litigation perspective, the insurance companies for manufacturers of these compounds are likely to have meticulously excluded cases involving the supplements contained on this list from coverage. Pursuing shell companies without insurance coverage does not, in any way, benefit a client injured by these products.

Being successful in these cases requires very diligent work and insight into these very specialized products is needed. The research is very time consuming when done by even the most knowledgeable people.

The FDA warning to manufacturers relating to misbranding is much like pursuing Al Capone for tax evasion in order to put him in prison for much worse things. A misbranding announcement is the “siren call” for much bigger problems in most cases.

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Consumer Reports recently reported that some supplements we take on a regular basis may actually be more harm than good. Consumers may not realize that manufacturers of supplements do not have to demonstrate that they are safe and effective before they sell their products to consumers.

Experts at the Institute of Medicine said this year that, “The FDA needs to use the same strict standards to regulate supplements as it uses for drugs, and should ask Congress for more power to regulate supplements.”

The FDA has repeatedly found hazardous ingredients, including synthetic prescription drugs, in supplements, and some natural ingredients can also be hazardous. There have also been claims that supplement sellers tell consumers that they can cure their sickness or replace their costly prescription medications with their supplements.

According to Nutrition Business Journal, in 2009, Americans spent more than $26.7 billion on supplements and the trend only seems to be growing. You can find a supplement pretty much anywhere that claims to cure any aliment or symptom; from a cold, to weight loss, an edge in sports, or just to stay healthy.

Consumer Reports states that, “We have identified a dozen supplement ingredients that we think consumers should avoid because of health risks, including cardiovascular, liver, and kidney problems. We also found products with these ingredients readily available in stores and online.” The report found that a group of ingredients were linked to serious adverse events by clinical research and case reports. The report also factored in whether the ingredients were effective for their claimed uses and how readily available they were to consumers.

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In a Press Conference on February 3, 2010 Sen. John McCain announced his intention to introduce a new bill that would amend DSHEA (Dietary Supplement Health Reform Act 1994) requiring manufacturers of Dietary Supplements to register and disclose all ingredients.

In the Press conference McCain was quoted “All we’re saying is, list the ingredients, OK?” “And register so people will know what they’re taking into their bodies. It’s not really outrageous when you think about it.”

Council for Nutrition CEO, Steve Mister, responded “The responsible dietary supplement industry represents the health and wellness interests of more than 150 million Americans who use dietary supplements each year. We have consumers’ health and best interests at heart because we recognize that without our consumers, we would not exist as an industry. ”

According to the Bill the definition of “new dietary ingredients.” Would be replaced by “‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary.

If the Bill gets passed the  FDA will have authority for mandatory recall as it has now only with medical devices and prescription drugs. The FDA could then determine and act  if there was reasonable that a product marketed and/or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded.

Presently the FDA, even with the new CGMP (Good Manufacturing Process) rule to fully roll out in 2010, has no power to enforce or recall a suspected dangerous product or conduct testing on any product for safety and efficacy. Interestingly as more reports of dangerous tainted dietary products hit the news even some manufacturers of Dietary Supplements have an voiced support legislation to ensure the health of the billion dollar supplement Industry by slowing the erosion of trust in the safety of their products.

The bill outlines proposed new changes that include:

• New facility registration requirements to identify all brands, products, and ingredients
• A revised definition of new dietary ingredients (NDIs) that would rely on an FDA-generated positive list of allowed ingredients
• Extension of existing adverse event report (AER) requirements, such that even minor AERs would need to be submitted to FDA annually
• Policing and record maintenance obligations for downstream manufactures and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers, respectively, of compliance with facility registration and product notification and rules.
• Obligations and authority for FDA with regard to removing products that present the risk of serious adverse health consequences or death, or are adulterated or misbranded

According to World Health Organization (WHO) there are one billion overweight adults worldwide and 300 million are categorized as obese. The World Health Organization cited several contributing factors among which are:

“increased consumption of energy-dense foods high in saturated fats and sugars, and reduced physical activity, Economic growth, modernization, urbanization and globalization of food markets are just some of the forces thought to underlie the epidemic.“

The mounting scientific and statistical evidence related to obesity illustrates a number of associated health risks of epidemic proportions. The many complications of morbidity is a head on collision with our current health care crisis.

WHO lists among the adverse effects of obesity including:

• high blood pressure
• high cholesterol
• high triglyceride
• insulin resistance
• respiratory difficulties
• chronic musculoskeletal problems
• skin problems
• infertility
• type II diabetes

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They are called “nutritional supplements”, “health additives” and “body enhancers”. Whatever the name, make no mistake, these are engineered drugs.

The Palm Beach Post had an editorial on Sunday related to an issue that Alyssa Diedwardo has written about a great deal. In fact, Alyssa talked in August of 2008, about the very problem that has led to the suspension of two major league baseball players.

The two unfortunate players, JC Romero and Sergio Mitre each went to a “health store” and purchased entirely legal compounds, right off the shelf: Halodrol and 6-oxo.  Both of these gentlemen tested positive for steroids.

A word of warning to consumers, and a particular word of warning to unwary adolescents, READ the ingredients! This is an industry that, for all intents and purpose, is completely unregulated. Arguably, in fact, it often appears as if the “health” supplement industry is experimenting as it goes along…with the public at large.

I invite you to read more about this industry and some of the problems being seen by visiting our Herbal Supplement website and check out articles written by Alyssa Diedwardo.