Tag Archive for: Food and Drug Administration

Dietary Supplements: Certified

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

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

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