The article at the end of this blog, from the NY Times titled: “New York Attorney General Targets Supplements at Major Retailers” was welcomed by us and many of our counterparts in the health supplement industry this week. As this NY Times article shows, unfortunately, there continues to be short-comings in the industry resulting in some very low quality supplements being produced. This is exactly why we wrote an earlier blog titled: “A Must Read Before You Buy Your Health Supplements”, that outlined 5 key points you must consider before you buy any health supplement (linked here).
Product Development Through To Manufacturing – Our Journey
When we first came to the U.S.A to get Stem Cell Worx Intraoral Spray manufactured, it took four long years to actually get our supplement to market. Here are the reasons why. There were relentless hours of research and development with scientists and bio-chemists, clinical testing, red tape and frustrations to work through. When we got to the actual manufacturing stage, the majority of our frustrations stemmed from Laboratories wanting to make our supplement another way to what we specified. This didn’t wash with us and we refused to work with any Laboratory that would not manufacture our supplement as per our strict criteria and specifications. The highest grade of ingredients must be used and its intraoral application is crucial in order to make this supplement work to its maximum benefit. This is what all the extensive clinical testing, both in-house and independently, had proven. It was certainly a wake up call for us when we reached the manufacturing stage but we persevered.
We had plenty of people (friends and some family members included) thinking we were crazy. They couldn’t understand what we were doing and why we were always working. We just kept at it and never gave up.
Here’s a quick snapshot of what we found when it came to working with Laboratories (and this is world-wide):
- Many Laboratories only manufacture pills and capsules. They prefer to do so, as pills and capsules are much cheaper and a lot quicker to manufacture than liquids. A lot of fillers, artificial sweeteners, poor quality extracts and low quality proprietary blends are put into pills and capsules. Many fillers are used for binding purposes. You will often see the words “proprietary blend” or “extract”, especially on a pill or capsule label. Proprietary blend generally means a group of poor, low grade ingredients and fillers have been mixed together, that provide minimal nutritional value. The same goes for the word “extract”, this means the purity of the ingredient is low. Beware also of the price, a very cheap supplement means just that, very cheap, low grade ingredients and manufacturing processes. See the link to our blog that outlines the pitfalls of these points in more detail.
- Finding a Laboratory that was specialized in liquid supplementation was a mission in itself. Six years ago, liquid health supplements were not that common. They have only become mainstream in the last couple of years, thanks to all the supporting clinical data and science that evidences how effective liquid health supplements are.
- Finding a reputable Laboratory was essential. We needed to work with a Laboratory that was experienced in manufacturing the actual ingredients in our supplement, one that was GMP approved for manufacturing liquid health supplements, and they had to have extensive quality control processes in place at the Laboratory. We had a number of Laboratories tell us they were very familiar with working with the ingredients in the formula. We therefore instructed them to make test samples for us. We were astonished that on receiving a number of samples from different Laboratories, they did not reach our standards at all. We immediately knew something was amiss. We therefore got their test samples tested ourselves, and on more than one occasion, the test sample was missing one of the main ingredients in the supplement. The Laboratories had clearly tried to save money by not ordering in the high grade, purity of ingredients we specified for the test samples, despite us paying them upfront to produce the samples. If Laboratories did not follow our criteria we quickly walked away and moved on.
- What we insist upon is the Laboratories we work with have each batch of ingredients independently tested for purity and quality before each product run is done. This is essential. This ensures that the purity of the ingredients match those that are stated on the certificate of analysis for each of the ingredients. Reputable Laboratories with strict quality control processes will only allow the correct label to go on the product (i.e. what is stated on the label must be in the actual supplement). No waivers are allowed. Not all Laboratories do this, due to the time and expense involved.
Essentials When It Comes To Manufacturing
When it comes to manufacturing, working with a reputable, long established Laboratory is essential and one who is very experienced in manufacturing the actual ingredients in the product. The supplement owner must work with Laboratories who will not take any shortcuts and who will not use inferior ingredients. The NY Article is correct in that “supplements are exempt from the F.D.A’s strict approval process for prescription drugs,” however Laboratories who are GMP approved must adhere to GMP rules for dietary health supplements and these regulations are mandated by the F.D.A, and a credible Laboratory will therefore not allow dietary health supplements to be labeled incorrectly.
We obviously ended up finding excellent Laboratories here in the U.S.A to work with who manufacture our supplement exactly as we specify, and they will be producing our new products in the future. However, it certainly took time, money and a lot of effort on our behalf to work through the processes and find the very best Laboratories here in the U.S.A.
Below Is The NY Times Article Titled: New York Attorney General Targets Supplements At Major Retailers
Source: NY Times
The New York State attorney general’s office accused four major retailers on Monday of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves.
The authorities said they had conducted tests on top-selling store brands of herbal supplements at four national retailers — GNC, Target, Walgreens and Walmart — and found that four out of five of the products did not contain any of the herbs on their labels. The tests showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.
The investigation came as a welcome surprise to health experts who have long complained about the quality and safety of dietary supplements, which are exempt from the strict regulatory oversight applied to prescription drugs.
The Food and Drug Administration has targeted individual supplements found to contain dangerous ingredients. But the announcement Monday was the first time that a law enforcement agency had threatened the biggest retail and drugstore chains with legal action for selling what it said were deliberately misleading herbal products.
Among the attorney general’s findings was a popular store brand of ginseng pills at Walgreens, promoted for “physical endurance and vitality,” that contained only powdered garlic and rice. At Walmart, the authorities found that its ginkgo biloba, a Chinese plant promoted as a memory enhancer, contained little more than powdered radish, houseplants and wheat — despite a claim on the label that the product was wheat- and gluten-free.
Three out of six herbal products at Target — ginkgo biloba, St. John’s wort and valerian root, a sleep aid — tested negative for the herbs on their labels. But they did contain powdered rice, beans, peas and wild carrots. And at GNC, the agency said, it found pills with unlisted ingredients used as fillers, like powdered legumes, the class of plants that includes peanuts and soybeans, a hazard for people with allergies.
The attorney general sent the four retailers cease-and-desist letters on Monday and demanded that they explain what procedures they use to verify the ingredients in their supplements.
“Mislabeling, contamination and false advertising are illegal,” said Eric T. Schneiderman, the state attorney general. “They also pose unacceptable risks to New York families — especially those with allergies to hidden ingredients.”
The attorney general’s investigation was prompted by an article in the New York Times in 2013 that raised questions about widespread labeling fraud in the supplement industry. The article referred to research at the University of Guelph in Canada that found that as many as a third of herbal supplements tested did not contain the plants listed on their labels — only cheap fillers instead.
Industry representatives have argued that any problems are caused by a handful of companies on the fringe of the industry. But New York’s investigation specifically targeted store brands at the nation’s drugstore and retail giants, which suggests that the problems are widespread.
“If this data is accurate, then it is an unbelievably devastating indictment of the industry,” said Dr. Pieter Cohen, an assistant professor at Harvard Medical School and an expert on supplement safety. “We’re talking about products at mainstream retailers like Walmart and Walgreens that are expected to be the absolute highest quality.”
In response to the findings, Walgreens said it would remove the products from its shelves nationwide, even though only New York State had demanded it. Walmart said it would reach out to the suppliers of its supplements “and take appropriate action.”
A spokeswoman for GNC said that the company would cooperate with the attorney general “in all appropriate ways,” but that it stood behind the quality and purity of its store brand supplements. The company said it tested all of its products “using validated and widely used testing methods.”
Target did not respond to requests for comment.
The F.D.A. requires that companies verify that every supplement they manufacture is safe and accurately labeled. But the system essentially operates on the honor code.
To read full article click here: NY Times Article In Full
