Tag Archive for: FDA

Questionable Comments on Dietary Supplements

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I hope you had a chance to read the article I referred you to on Tuesday; you can still read it by clicking on this link. For the record, I’m not a fan of the AG1 product. In my opinion, supplements should not mix herbals from medicinal plants with vitamins, minerals, and phytochemicals. That aside, there are three main points I alluded to in Tuesday’s Memo so let’s take a look.

Pharmaceuticals vs. Supplements

First, dietary supplements are regulated by the FDA, just not in the same way as pharmaceuticals. Here’s the difference:

  • Medicines have to prove they are safe before they are released for use by the public, but they can claim they will prevent, treat, or cure diseases.
  • Supplements cannot make such claims; they can make only structure-function claims: “This product may help digestive health,” for instance.

This “fact” as the writer proclaimed is the mantra of the American Medical Association and FDA. It seems worse now that they’re producing videos together for the general public. There’s a lot more arguments here, but that’s for another time.

So Much Beta-Carotene

The author brought up the beta-carotene and smoking studies, but I don’t understand why he didn’t question the amount of beta-carotene used in either study. The studies used four to six times the actual intake of beta-carotene at that time. These made these studies suspect because of the extreme use of beta-carotene in the studies. That’s what should be questioned.

Inadequate Nutrition

The proof was poor that he used to suggest that over 75% of the adult population get adequate vitamins and minerals from the food they eat. It was a study based on data collected via food-frequency questionnaire from specific segments of the Hawaiian and Asian populations in the mid 1990s, and I think we all know that those diets differ from the typical diet on the U.S. mainland or Europe. There are data from the 2021-2023 NHANES study available. It’s difficult to compare the data because of the way they were analyzed in the prior study, but a look at the nutrient intake from food looks more like we get 66% of the RDA, at least for some nutrients such as vitamin A, and worse for other nutrients.

Are there more problems? Yes, but that’s enough. This was a rehash of old arguments to say supplements are not necessary. But there’s one question that no one ever asks in any studies. I’ll leave you in suspense until next week when we look at what one physician said about creatine. I think you’ll be surprised.

What are you prepared to do today?

        Dr. Chet

Dietary Supplements: Certified

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Recently I watched a webinar on mitochondrial health and athletic performance co-sponsored by the American College of Sports Medicine and a nutritional company. The speakers were a clinical researcher and a PhD dietitian for a professional basketball team. I’m going to review what the clinical researcher talked about on Saturday.

Today I’m going to focus on a comment by the dietary specialist. She believes as I do that supplements complement a good diet, but when she started talking about dietary supplements, she said they aren’t regulated by the Food and Drug Administration. At that point, I would typically stop listening because she’s incorrect; both the FDA and the FTC regulate dietary supplements; it’s just done in a different way than over-the-counter medications and pharmaceuticals.

Then she said that whatever supplements she recommends to her players, she looks for products that are certified by NSF or the United States Pharmacopeia (USP). I agree. These are not easy certifications to obtain. It isn’t just that the supplement is tested once and it’s over—it’s an ongoing process that costs a lot of money for the company, but they’re industry standards. Certification is something you should consider when you purchase dietary supplements of any type but especially related to sport performance.

What are you prepared to do today?

        Dr. Chet

Teaching Doctors About Supplements, But Not Really

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If you haven’t watched the videos that I talked about Tuesday, please take the time to watch them, preferably before you continue reading—I’d like you to form your own opinion about the videos before you get my perspective. I came away with three opinions about the videos, other than they really focused on dietary supplements not being approved by the FDA. Of course, no legitimate healthcare professional or supplement manufacturer ever said they were; consumers may not know that, but I would hope doctors did.

First, the second video discussed potential drug-supplement interactions. There have been few direct studies on those interactions; most are case studies involving the use of herbs such as St. John’s wort and ginkgo biloba that have been published in peer-reviewed journals. What they don’t say is that very few studies have examined drug-drug interactions either. How do they find out about them? Trial and error from reports to the FDA’s adverse effects reporting system.

That addresses my second opinion. There was a strong focus on reporting adverse events from dietary supplements to the FDA. One would think that’s a good thing, but the list of adverse events they listed included every system in the body. I get reporting an allergic reaction, but how would a physician attribute gastrointestinal or cardiovascular issues to a dietary supplement after putting the person on a new medication? It’s just as likely to be due to the medication. Seems to me like an open door to lots of irrelevant reports.

Finally, they spoke about some supplements interacting with blood tests. The only one I’m aware of is excessive biotin intake affecting the troponin test for potential cardiac events. One would expect an extensive list would be provided; the problem is none exists because that’s the only known interaction.

The Bottom Line

There are 13 vitamins. There are dozens of minerals, most found in trace amounts. There are hundreds of herbs, plus nutrients that don’t fall into any of those categories. All can be found in dietary supplements. If I were a physician who spent time watching the videos, I really wouldn’t know more about those nutrients in supplements than I did before I watched. I would have learned only two things:

  • The FDA does not have the authority to approve dietary supplements.
  • If a patient takes dietary supplements, anything bad that happens in the body should be reported as an adverse event.

A lot of red flags were waved when the issues deserved a yellow flag at most. I can think of only one word: sad. With the lack of training and knowledge about supplements among doctors, I think those two organizations could have spent their money better and created videos that would have really helped doctors and their patients.

What are you prepared to do today?

        Dr. Chet

References:
1. https://www.youtube.com/watch?v=GYJYPCJmspE
2. https://www.youtube.com/watch?v=qqyP-vbtlZY

Teaching Doctors About Supplements

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In late May, the Food and Drug Administration (FDA) in partnership with the American Medical Association (AMA) released two short videos to teach physicians about dietary supplements, plus a third aimed at consumers.

The first video spent time defining and explaining what a dietary supplement is, the delivery systems companies use such as tablets,  gummies, bars, etc., and the role the FDA plays in the process. The second video focused on adverse events, how to report them, and a sample conversation between a doctor and patient. I encourage you to watch the videos at the links below.

I think there are two important points of the videos. First, the FDA does not approve dietary supplements in the same way that they approve pharmaceuticals—obviously their main point because it was repeated several times. In exchange for allowing supplements to be introduced quickly, companies do not have to prove safety or effectiveness. However, if they make any health claim, they must report that to the FDA within 30 days of making the claim. Those claims are restrictive; a company can’t say on the bottle or promotional materials “cures heart disease” but can say “contributes to a healthy heart.”

Second, you should always discuss the supplements you take with your physician, especially if you take medications. It can be a pain if you take a lot of supplements, but you must do it because there can be interactions. For example, calcium, whether from food or a supplement, interferes with the absorption of thyroid medications. They should not be taken together (which is tricky because it’s recommended thyroid meds be taken at bedtime when you may be taking a calcium-magnesium supplement to aid sleep).

Those are what I see as the positives of these videos that cover supplement companies and patients; there’s no information about how supplements work or which supplements do what. I’ll cover that aspect of the videos on Saturday. In the meantime, take the time to watch both 10-minute videos.

What are you prepared to do today?

        Dr. Chet

References:
1. https://www.youtube.com/watch?v=GYJYPCJmspE
2. https://www.youtube.com/watch?v=qqyP-vbtlZY

It’s Official: Prescription Fish Oil

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The U.S. Food and Drug Administration approved the prescription fish oil Vascepa for expanded use on Friday, December 13. The approval for the medication is for the secondary prevention of cardiovascular disease in patients under the following conditions:

  • Triglycerides above 150 mg/dl for everyone with diagnosed CVD and taking a statin medication.
  • Diabetes and two or more additional risk factors for CVD along with taking a statin medication.

The modifiable risk factors for CVD include smoking, obesity, high cholesterol, hypertension, and sedentary living. Remember from our prior series, secondary prevention may help reduce the risk of CVD symptoms developing.

My concerns are the same as they were before. Triglycerides less than 250 mg/dl can be resolved by diet and exercise in most people. Because the mechanism of action is unknown as to how the prescription works, there’s no reason to think that reducing triglycerides by lifestyle change won’t work as well as the prescription; the clinical trial didn’t track this data.

Speaking of lifestyle change, keep in mind the website specials on the Optimal Performance program as we get ready for the New Year. The Basic Meal Plan will teach you how to change your diet to reduce triglyceride levels if your levels are too high.

What are you prepared to do today?

        Dr. Chet

References:
1. http://bit.ly/36EbsYK
2. N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Primary vs. Secondary Meds

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One of the key questions for the FDA advisory panel to consider was whether the prescription fish oil was a primary preventer of cardiovascular disease or a secondary preventer. What’s the difference? Primary prevention of CVD would impact the disease and stop events before they occurred in the subjects taking the fish-oil medication. Secondary prevention would prevent additional CVD events from happening in those with established CVD.

If you were a type 2 diabetic with an additional risk for CVD such as obesity or being a smoker, taking the prescription fish oil with a statin would prevent a heart attack or stroke from happening; that’s primary prevention. Based on the Reduction of Cardiovascular Events with Icosa-pent Ethyl–Intervention Trial (REDUCE-IT) that didn’t happen, but it did prove to be a secondary preventer of additional cardiac events in those subjects in the study with established disease.

The question is whether the FDA will approve the prescription fish oil as a primary prevention or a secondary prevention pharmaceutical. The advisory panel seemed split on that count. The assumption by some was that there was disease present even though the event had yet to occur. Others said “prove it” by doing an actual clinical trial to examine that question. We’ll find out how the FDA decides later this year. As I mentioned yesterday, the financial implications are huge.

There are still some things to consider with the clinical trial, and I’ll cover that on Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Prescription Fish Oil Update

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“This Fish-Oil Heart Drug Could Be Big, Could Be Huge.” That was the headline in a well-known financial report after a Food and Drug Administration panel unanimously voted in favor of an expanded use for the prescription fish-oil drug. I mentioned this was a possibility when I first talked about Vascepa in October. The FDA is expected to make a final decision by the end of the year.

What is the expanded use? The medication could be prescribed to those who have established heart disease or type 2 diabetes with another CVD risk factor and are already taking statin medications to lower cholesterol. The advisory panel approved the use because research showed that when combined with statins, it could reduce CVD endpoints such as death, heart attacks, and strokes by an additional 4.8% when compared to a placebo over a 4.9 year follow-up period, 17.2% versus 22%.

One more thing. The medication could be prescribed to those with triglycerides as low as 150 mg/dl. That would include millions more potential users in the U.S. and Canada alone. You can see why the headline was in the financial news; the potential profit for investors could be huge. A lot is riding on what the FDA decides. I’ll explain that on Thursday.

What are you prepared to do today?

        Dr. Chet

Reference: Bloomberg Online. Max Nisen. Posted 11-15-2019.

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