Tag Archive for: supplements

Quality Manufacturing: Own It

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The most important trait of a quality manufacturer of dietary supplements is to own as much of the process as possible: farms to grow plants, laboratories to test all components of the supplements, scientists to base formulations on the latest research, manufacturing facilities for the products, and elements of the distribution process. As I said, no company can process every nutrient that may go into a supplement but the more they control, the better the oversight.

The problem will always be the lack of control. As control decreases, the probability of tainted supplements increases. Anyone, and I really mean anyone with the money, can put together a formula for supplements and find a manufacturer that will make it. The ingredients can be organic and natural or they can be the cheapest available. That person can also find a warehouse to store it and another company to distribute it, especially in these days of Internet shopping. Anyone can start selling his own formulations for supplements within a week to a month.

Lack of ownership isn’t necessarily a bad thing; we can’t begin with the premise that everyone is out to cheat everyone by cutting corners. But while someone might be an excellent nutritionist with a great idea for a supplement of some sort, they’re not necessarily an expert in the entire process of manufacturing. That could result in problems with the finished product that were unseen due to a lack of expertise.

In this week’s Memos, I’ve covered a simple way to assess the manufacturers of supplements. The only thing you have to do is ask the right questions before you buy. That protects you and your family.

What are you prepared to do today?

Dr. Chet

 

Quality Manufacturing: Independent Testing

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Let’s continue our look at how quality manufacturers could prevent tainted products. In-house testing is important, but all work should be verified by an independent testing company. There are several labs that perform such services such as NSF and USP. There are three important services they can perform:

  1. Inspect the facility to make sure the manufacturing process complies with FDA Guidelines for dietary supplements known as Good Manufacturing Practices.
  2. Verify the quantities of nutrients in the products listed on the product labels.
  3. Check for the presence of contaminants of all types.

It seems simple enough. Why don’t all manufacturers use independent testing companies? One of the reasons is cost: it’s not inexpensive, and it also must be continuous. But the trademark of a quality manufacturer is independent testing of the manufacturing facilities and dietary supplements they make.

We’ll finish this up on Saturday with one of the most important traits of a quality manufacturer.

What are you prepared to do today?

Dr. Chet

 

Quality Manufacturing: Establish Rules

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Last week’s Memos were about supplements that were tainted with pharmaceuticals. What can manufacturers do to insure their products are not tainted? Mistakes can always happen, but what can be done to get those errors as close to zero as possible? That’s what we’ll cover this week.

Let’s begin with this premise: no manufacturer of dietary supplements grows every plant they use or makes every vitamin in their supplements. There’s nothing wrong with that because the growth and production of supplements is so complex. However, there are two things that a manufacturer can require from their vendors.

First, that they follow specific guidelines in the growth of plants: what type of seeds, what type of organic herbicides, how the plants must be harvested, and on and on. Following guidelines would also be required of outside companies who make vitamins and process minerals.

Second, all vendors’ products would be tested for contaminants upon arrival before any final products are made. If they do not meet the guidelines, the shipment is rejected.

Monitoring the quality of ingredients is the first step in making sure a dietary supplement contains untainted ingredients. I’ll cover another in Thursday’s Memo.

What are you prepared to do today?

Dr. Chet

 

Tainted Supplements: Buyer Beware

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There was a big problem with the papers that were published in JAMA and the resultant media headlines: the authors and commentator lumped the tainted products into a single category of dietary supplements and categorized these questionable manufacturers and their tainted products with all manufacturers of dietary supplements. That was simply wrong, and people in health news know better. There will always be unscrupulous companies out to make a quick buck and laughing all the way to the bank.

Some of the tainted products are still on the market today. Most are available only online, and their websites contain no information about the company who makes them or how they were made. They might simply be the same product sold under different names; there’s no way to tell.

The everyone-in-the-pool approach used by the authors reflects an underlying belief that the FDA should give approval to every dietary supplement. There are healthcare professionals who don’t like supplements of any kind. With this kind of news, they make the leap that all supplements are equal, and thus all require more restrictive oversight to stem the tide of tainted supplements. That’s just foolish. Quality manufacturers that want to continue to be in business follow the rules set out by the FDA for dietary supplements. Fly-by-night companies won’t, no matter what the laws say.

Buyer Beware

The articles do raise an important concern: how do you know whether the products you’re buying are made by a reputable manufacturer or not? After all, you’re going to be putting them in your body. Do your homework, just as you might do with any other consumable product. Check out the company online to the extent you can. The more information you can find, the better. If there’s not much info, consider that a red flag.

But how do you know what to look for? I’ll cover that in next week’s Memos, so make sure you don’t miss them.

What are you prepared to do today?

Dr. Chet

 

References:
1. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3337.
2. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3329.
3. FDA Database: http://bit.ly/2Pyq0B3

 

Which Products Were Tainted?

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The logical concern is this: what products were on the list of supplements that made up all those headlines? There were over 700 products on the FDA list of tainted products, so I think there’s a better way to ask the question: what were the categories of products?

1. Sexual performance was the overwhelming leader.
2. Weight loss was second.
3. Muscle building also made the list.

The problem with the sexual performance products was that they contained actual Viagra, Cialis, or one of the other medications used for erectile dysfunction. The weight loss products contained a pharmaceutical that has been taken off the market because of side effects. Most of the problematic muscle-building products contained anabolic steroids. When people take these types of medications pitched as dietary supplements without knowing what’s in the product, the potential for unexpected consequences is substantial and could threaten their health.

I reviewed the entire list of supplements on the FDA list and found no products—not one—offered by a reputable company. No multivitamins. No antioxidants. No herbals such as echinacea.

Here’s the bottom line: these were not dietary supplements, they were pharmaceuticals that skirted the FDA regulations for pharmaceutical and over-the-counter drugs and the FTC rules for honesty in advertising. But that’s not what the paper’s authors and the commentator said. We’ll finish this on Saturday.

What are you prepared to do today?

Dr. Chet

 

References:
1. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3337.
2. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3329.
3. FDA Database: http://bit.ly/2Pyq0B3

 

Tainted-Supplement Headlines

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I’d like you to read these three headlines, stop, and identify the first thought that comes to your mind:

“Hundreds of Supplements Are Tainted With Hidden Pharmaceutical Drugs”

“Hidden Drugs and Danger Lurk in Over-the-Counter Supplements, Study Finds”

“Supplements Often Tainted by Hidden Drugs”

No matter what supplements you’re taking, the thought “I wonder what’s really in my supplements?” must have passed through your mind, even just for a second. I know my readers were thinking that. Should you be concerned? Will that multivitamin or B complex you’re taking contain something dangerous?

That’s the takeaway from these headlines about a paper published in the JAMA Network Open journal (1). The article had a corresponding commentary criticizing the FDA for dereliction of duty in not seeing that these products were removed from the marketplace. (2).

There are some important lessons here and this is the first one: while numerous publications called this a study, it was not. A few scientists reviewed the FDA website that listed tainted products marketed as dietary supplements; the FDA had sent warning letters to the manufacturers to stop selling the products. The authors grouped them by category of product type and then spent eight pages talking about them. According to the paper, they did nothing else—no other investigation or analysis.

The type of products that made the tainted products list wasn’t surprising if you closely follow health news. I’ll tell you what they are on Thursday.

What are you prepared to do today?

Dr. Chet

 

References:
1. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3337.
2. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3329.
3. FDA Database: http://bit.ly/2Pyq0B3

 

Yes, Supplements Matter

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The study that was published in the Journal of American Academy of Cardiology created several issues that go beyond the headlines of supplements being of no benefit. Let’s first take a look at the published results of the study.

The researchers found that most supplements such as multivitamins, vitamin D, calcium, and vitamin C do not have a significant effect on cardiovascular disease or overall mortality. On the other hand, folic acid had a significant beneficial effect on reducing stroke and overall CVD, and B-complex, a vitamin with a variety of B vitamins in it, also helped reduce the incidence of stroke. However, the study showed antioxidants had a negative effect on all cause mortality as did niacin. Whether beneficial or not, the results, while statistically significant, were not clinically significant.

The researchers stated that they expected beneficial effects on the reduction of cardiovascular disease and overall mortality. The fact that they did not find those benefits resulted in the headlines that supplements don’t matter.

Here are just three of the issues with the study. They included studies with different nutrients as well as studies that didn’t have the same amount of nutrients. The RCTs included in the analysis did not have the exact same amounts of any given nutrient in the supplement; three of the studies on antioxidants and cancer mortality had different amounts of beta-carotene and vitamin E. Another way of putting it was they not only were comparing apples to oranges, but they also compared three oranges to a dozen apples.

Another issue was adherence to the study rules. The subjects did not necessarily take all the supplements they were given, and compliance varied between the studies. Positive or negative effects could be determined by whether subjects took all of their supplements or took them only when they remembered or felt like taking them. The adherence to supplement use varied by study.

Here’s one more issue. Every RCT used supplements as a potential treatment for a disease—in this case, diseases related to the heart and the death rate from heart disease or other diseases. It’s the treatment model used by physicians: the pill, whether pharmaceutical or supplement, must reduce the incidence of or cure the disease. While desirable, that’s not what nutrition is all about.

The Bottom Line

While we would like to see research results that prove that we can live longer or better by taking supplements, that isn’t really the point in my opinion. We take supplements to fill the gaps in our diet. As the researchers point out, if everyone ate more plant-based foods, we could meet the minimal amounts of nutrients our bodies needs. That hasn’t happened in the 30 years I’ve looking at this issue, and I don’t see it changing any time soon.

Taking vitamin and mineral supplements serves as nutritional insurance to support your body’s processes and to make sure you don’t open the door for deficiency diseases; supplements are more like shotguns than rifles. Supplements do matter and I’m going to continue to take mine every day.

There are so many issues with this research paper—much too long for this Memo—that I recorded a Straight Talk on Health about them. If you’re a Member or Insider, you can listen to Research Update on Supplements any time. If you’re not, now is a good time to join.

What are you prepared to do today?

Dr. Chet

 

References: Jenkins, D.J.A. et al. J Am Coll Cardiol. 2018;71(22):2570–84.

 

Supplements: Helpful or Harmful?

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About a week ago when a press release about a study published in the Journal of American Academy of Cardiology stated that vitamins and minerals don’t seem to help the health of those people who use them; they should stick to getting nutrients from the food they eat. As you can imagine, I got questions from many readers.

For those of us who use dietary supplements, have we been wasting our money? Or maybe as part of the study showed, we’re doing ourselves harm? Don’t throw out your supplements just yet.

The study was a meta-analysis that examined randomized controlled trials (RCT) since the U.S. Preventive Services Task Force (USPSTF) Recommendations for Dietary Supplements was published in 2012. They examined RCTs that used multivitamins, vitamins and minerals, and antioxidants to determine their affect on health variables related to cardiovascular disease and overall mortality.

Was the study done well? Yes and no. They included RCTs that examined the use of specific supplements and health outcomes. The problem is that they didn’t examine the quality of the supplements used in those studies. That’s a significant problem but not the only one. More on this Saturday. Until then, regardless of the headlines, take your supplements if you know why you’re taking them.

What are you prepared to do today?

Dr. Chet

 

References: Jenkins, D.J.A. et al. J Am Coll Cardiol. 2018;71(22):2570–84.

 

Why Nutrition Is a Process

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A celebrity doctor who specializes in cancer treatment said something that caught my attention, and it goes to this question: why are some people cured by specific treatments while others don’t respond at all? In his opinion, it’s because the cancer creates a new system in the body that competes with the other systems.

The new system may be different in each body once the cancer is established, which could mean that everyone really requires an individual approach. A systems approach would be necessary only if the cancer gets too established; early diagnosis can use treatments that work in most people. Late diagnosis means the cancer has established a system with strengths and weaknesses that are unknown. But the systems approach isn’t limited to cancer.

What’s a Systems Approach?

A systems approach is simply this: we attempt to reach a goal by looking at the interactive nature and interdependence of all the factors in an entity.

Here’s an analogy: you flip the switch for the light in your kitchen, but the light doesn’t go on. What could be wrong? The light won’t work if:

  • Your bulb is burned out
  • Your circuit breaker needs to be reset
  • An electrical outlet somewhere has a tripped GFCI
  • Your switch has gone bad
  • A wire is loose in your light fixture
  • The power is out to your whole house

Turning on a light is easy—my grandson Riley is very good at it and he’s not even three. But if it’s not working, you have to look at each element of the system to find the problem and get the kitchen light back on.

How Vitamin D is Part of Your Bone Health System

While osteoporosis or weight gain doesn’t create a new system like cancer does, there are numerous steps in both processes. On top of that, if we’ve been on the path to bone loss or weight gain, there may be changes in normal metabolism that have to be overcome.

Let me explain using vitamin D for bone health. Whether we make vitamin D in our skin, get it from food, or take it in supplement form, it has to be processed by the liver to become the active form to promote bone growth. If there’s a defect in getting the raw vitamin D from food or a supplement into the bloodstream and on to the liver, not enough vitamin D would be made into the active form. Or there may be a defect in the processing of the raw vitamin D once it gets to the liver. Or there may a defect in the receptor for the active vitamin D on the target tissue. I could go on and on about where issues could occur, but I hope you get the point. Right now, we have no idea where the issue might be for the use of vitamin D in an individual just as we don’t know where the weak point of a cancer system might be and thus where we should attack.

Do we quit? No. We simply use a systems approach—we look at every step necessary to reach our goal and what we can do at each step. We begin with taking vitamin D for a specific period of time. We then get re-tested, most likely a bone density scan. If there’s growth, great. If there’s not, then we either add more D or add calcium or switch to a different form of calcium. Then retest. If that doesn’t work we can add vitamin C or glucosamine, both critical to the manufacture of connective tissue. There are other factors such as smoking and exercise that also impact bone growth. We systematically add new variables or add more of some that we’re already doing. Might this take a long time? Yes. Would we have to pay attention? Yes. But is it a natural approach to complicated conditions? Again, yes. No matter what the condition, if you’re going to try to deal with it nutritionally, that’s the approach you’ll have to take. You have to find what works for you.

The Bottom Line on Vitamin D

The systems approach goes a long way to explain why some people benefitted from vitamin D and calcium to prevent fractures and others did not. The only fact the meta-analysis study proves is that vitamin D and calcium supplementation don’t work for everyone. The key is to move on to the next approach; it may be different supplements or it may even be a medication. More options must be tried until a solution is found for each individual.

Over time, I’m going to continue to explore this concept of a systems approach to nutrition. I have no idea where it will lead, but it’s worth spending more time thinking and researching it.

What are you prepared to do today?

Dr. Chet

 

Reference: JAMA. 2017;318(24):2466-2482. doi:10.1001/jama.2017.19344.

 

You Actually Have to Take the Supplements

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The authors of the study on calcium and vitamin D supplementation as they relate to fractures were all orthopedic surgeons, as stated in the paper. They had no known training in nutrition. Maybe not statistics either.

When you perform a meta-analysis, each research study included is given a weight in the form of a percentage, which indicates how much it contributed to the outcome. Not all studies should contribute equally; that helps to eliminate the bias of a tremendous benefit in a very small study versus a large study with no benefit. They didn’t seem to read something in three studies that contributed close to 90% of the analysis (2-4): the authors of those papers said that the reduction in fractures did occur, or at least bone was restored, when the subjects took over 80% of the doses of calcium and vitamin D they were supposed to take. The problem: average compliance was around 50%.

What these surgeons could have done was tease out the data on those subjects who were compliant and analyzed that data. What they might have had were results that demonstrated that in order to get a benefit, subjects had to take the supplements regularly. That would have been meaningful. Instead, inexperience or ignorance left us with headlines but little else.

Still, there are some questions that were raised in my mind and I’ll cover them on Saturday. But one thing won’t change: if you’re going to take supplements of any kind, you’ve got to actually take them if you want a benefit.

What are you prepared to do today?

Dr. Chet

 

References:
1. JAMA. 2017;318(24):2466-2482. doi:10.1001/jama.2017.19344.
2. Lancet. 2005;365(9471): 1621-1628.
3. Arch Intern Med. 2006;166(8):869-875.
4. Am J Med. 2006;119(9):777-785.