Faking it with supplement products is not acceptable !

by Dr. Alan Kadish NMD

What’s in your supplement should not be a guessing game. It’s sad to keep reading reviews of many supplement manufactures who just don’t get it.

Label contents:

Having the contents of your label reflect on whats in your bottle per capsule/pill/power or liquid is essential. Not an option, not even if it’s a scotch off the mark. Recently the FDA finally went after the fake Viagra™ type of supplement manufactures….. again. The use of actual drugs in a supplement product should be an obvious violation and should be removed from circulation ASAP.

FDA:

Unfortunately the way the FDA works or should I say fails to function in a timely manner as it that it keeps many of the less than acceptable products on shelves, until there is an outcry or some other health issue takes place. I appreciate that there are literally hundreds of thousands of supplements flooding the market. There are specific groups that seem to be more contaminated than others. One can look at the weight loss category, muscle building, and of course erection products among those that seem to be on the continuous slide towards drug inclusion vs  really being a supplement. 

On the other side of the bad news coin, the latest consumer reports lends us more reason to use caution in choosing a brand of products, especially when your counting on the product being as advertised. In one of the latest evaluations of a product to lower your cholesterol with a well proven and very safe herb, red yeast rice, there was a substantial difference between brands with the active ingredient 30 times the amount, dependent on brand. (see article below)

It should be noted that none of the supplement manufactures will list the active ingredient amount as the FDA will classify them as a drug. However as a consumer you want to know that your taking the same dose per pill, per bottle and can maintain a consistent change in your cholesterol. This two sided problem is putting consumers at risk. 

For those of you who have read my other blogs on supplements, you know that I am a proponent of a limited number of supplement manufacturers who have consistently been at the forefront of quality control and maintain their standards well above those of the typical supplement manufactures. 

The FDA requirements for supplement manufacturing are focused on obvious areas: potency, authenticity, microbiology, stability  and a certificate of authenticity. But considering that >50% of herbal products come from overseas it’s more than preferable that more evaluation takes place before blindly accepting the suppliers word. 

You might have caught that the FDA regulations don’t address pesticides, herbicides and a host of other chemicals that ideally should not be in your supplements. Testing for heavy metals, such as lead and cadmium should not be an option, especially when they have been found in the raw materials and ultimately the finished products. ( Consumer Reports Protein Supplements 2018 ) It’s important to recognize that even small amounts are cumulative and have the potential for causing long term serious health effects. 

Pricing:

And let’s get clear on pricing. Higher costs are not always an indicator of value. Especially in this industry. There are many times where a herbal product is less than ideal regarding the concentration of the active ingredient. You can mix some of the isolated active ingredient into the batch, reject the batch or if less than scrupulous redo the evaluation and/or claim it meets the label statement. Yes this happens occasionally. 

Label Reading:

Have you examined the label and noted that the product is manufactured for the company, by another firm ? This is not a complete no go however, it means that the products quality control is in the hands of a third party. I’m not implying that this can’t  result in a good product but it limits the selling firms ability to monitor the source, handling and the finished product. Many who use a contract manufacturer will visit a firm and ask for the necessary paperwork.  The contract manufacturer should be closely monitoring all of the production actions and ideally will be in compliance with the supplement regulations and preferably more. 

Have you noticed that some of the largest supplement manufactures color their offerings using synthetic dyes ? Why would you want to expose yourself to these questionable product colorants when clear capsules, uncolored tablets or powders are available ? Yes the use of natural colors is typically more expensive, but what are  you purchasing. Hopefully it’s the product regardless of the fancy package or color of the supplement. 

Another questionable practice that is totally legal is to put a long list of items in your product with the intent of making the consumer feel like they are getting a “comprehensive” product. If you’re not familiar with the scientific literature for a specific item you will often find the amount present to make a difference would require you to take an inordinate amount of pills. This sales approach is solely a branding method making the consumer feel like they are covering the basis. Don’t think for a second that this is a good approach. It’s akin to going to the gas station and asking for a few ounces of gas. 

As a consumer what can you do, without a laboratory or the requisite science degree in evaluation methodologies. It’s imperative to be keen on either knowing someone who understands the industry, keeping up with the various consumer watch groups which are both a time requirement and cost or literally throwing caution to the wind and buying what sounds legitimate. Obviously the first choice would ideal from both a health and cost effective perspective. After working in this industry for 35 years, it’s clear that there is an important need in having consumer friendly approaches via a paid service, such as Consumer Labs, Consumer Reports and others but only if you recognize their limitations.

Not all brands can be tested nor will most consumers take the time to research each an every product they purchase. 

Take Aways:

Knowing what you need, by testing, before taking a supplement can and should be a conversation with your healthcare provider.

Price is not the total determinant of quality however there is a threshold where cheap is indeed just that and quality can not be maintained.

Is the supplement manufactured by the company or is their product made by a contract manufacturer ?

Does the manufacturer use sound science to put the proper amount of a nutrient into their formulation ?

There are good to excellent contract manufacturers, however in house direct from the source to a finished product can can result in a superior product.

Third party assays of products is important and ideally with each and every batch. Don’t hesitate to ask a company for batch information and…. good firms are happy to share.

As one thought, many of the supplements on both the NaturalPartners.com and EmersonEcologics.com sites have a much higher level of scrutiny. Is it enough ….depends on your needs and situation from a health perspective.

You might also evaluate the webpage by Vital Nutrients on their standards.

Disclosure: I have no fiduciary association with Vital Nutrients, Natural Partners or Emerson, I only recommend these firms as some consumer options.

BREAKING NEWS

ConsumerLab Tests Red Yeast Rice Supplements

Few products sampled provide enough cholesterol-lowering compounds to likely be effective. 08.28.18

Research shows that red yeast rice, which contains naturally-occurring lovastatin compounds, can lower “bad” LDL cholesterol. However, because amounts of lovastatins are not typically listed on supplement labels, consumers have no way knowing if they are taking an effective dose. Recent ConsumerLab tests of red yeast rice supplements on the market found most did not contain amounts of lovastatins shown to lower cholesterol in clinical trials. Amounts of lovastatins in certain products were also found to have decreased substantially since the same products were tested by ConsumerLab several years ago.

“If used according to their suggested serving sizes, only two of the nine red yeast rice supplements we tested would provide amounts of lovastatin known to lower cholesterol,” said ConsumerLab president Tod Cooperman, MD. “Unfortunately, this means that some consumers may be relying on—and spending money on—products that are unlikely to be effective.”

Clinical studies of red yeast rice have shown reductions in LDL cholesterol of about 20% from supplements providing between 4.9 mg to 27 mg of lovastatins per daily serving. But ConsumerLab.com’s tests showed that most of the products it selected for testing contained much lower amounts, and there was wide variation between products, with lovastatins ranging from just 0.43 mg to 12.9 mg per suggested daily serving. Four products were found to contain 37-81% less lovastatin than when tested by ConsumerLab in 2014.

None of the products were found to be contaminated with citrinin, a potential kidney toxin caused by fungal growth in rice products which ConsumerLab has detected in red yeast rice supplements in previous years. ConsumerLab.com first tested red yeast rice supplements in 2008, when it also found large variation in the amount of lovastatin provided, as well as elevated levels of citrinin in several of the products. The results were published in a peer-reviewed article in the Archives of Internal Medicine.

Labels on red yeast rice products generally do not disclose their lovastatin content due to concern that the supplement will be considered an unapproved drug by the FDA and removed from the market, since lovastatin is a prescription drug (originally sold as Mevacor). Red yeast rice may be effective for some people with elevated cholesterol levels who don’t respond to prescription statin drugs, however, as ConsumerLab’s tests showed, it may be difficult to ensure a consistent dose when using red yeast rice.

The new findings are available online in ConsumerLab’s Red Yeast Rice Supplements Review, which includes it’s Top Pick—a red yeast supplement that provided amounts of lovastatins known to work at a good value.

The review provides test results and comparisons for nine red yeast rice supplements selected for testing by ConsumerLab: Amazing Nutrition Red Yeast Rice, HPF Cholestene Red Yeast Rice, Mason Natural Red Yeast Rice, Nature’s Plus Herbal Actives Red Yeast Rice, Nature’s Sunshine Red Yeast Rice, Nature’s Way Red Yeast Rice, Solaray Red Yeast Rice, Thorne Research Choleast, and Whole Foods Red Yeast Rice. The review also summarizes the clinical evidence for red yeast rice, dosage and how to take red yeast rice, as well as safety, side effects and potential drug interactions.

Court Orders Injunction Against Companies Selling Products with Undisclosed Drugs

FDA lab testing found some products contained undisclosed sildenafil.09.04.18

The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The court order alleges the defendants violated the FD&C Act by selling unapproved and misbranded drugs to U.S. consumers using more than 100 websites. According to the complaint, the label on the defendants’ products claimed—without FDA approval or clinical studies demonstrating safety and effectiveness—that the products could treat or prevent a variety of serious conditions, including erectile dysfunction, impotence and prostatitis (swelling and inflammation of the prostate gland). The complaint also stated the products were misbranded because they did not include adequate directions for use and their labels omitted material information.

FDA laboratory testing found some of the products contained undisclosed sildenafil, which is the active pharmaceutical ingredient in the prescription drug Viagra. The use of sildenafil, particularly when its presence is hidden from consumers, can pose serious health risks to patients with underlying medical issues, such as heart disease and high blood pressure.

“Despite our warning, the defendants refused to comply with the law, and they put consumers at serious risk,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Particularly egregious is the undisclosed presence of sildenafil, a potentially dangerous active pharmaceutical ingredient that requires a doctor’s prescription. We will continue to take aggressive action when we learn of unsafe products and dishonest marketing.”

The FDA issued a warning letter to the companies after the agency conducted laboratory analysis that revealed the presence of an undeclared pharmaceutical ingredient in several products.