Tag Archive for: FDA Guidelines

Research on Health and Apple Cider Vinegar

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Watching more television than usual means I’m seeing more commercials than I’m used to seeing. It’s time to take a look at some dietary supplements that make health claims in television commercials. I’m going to focus on the science behind any claims being made on the product label or on the product’s website to see if they pass the FDA regulations. The product claims are worded as the FDA suggests; the question is whether the science is substantial enough to make the type of claims the FDA allows.

The first product is Goli, an apple cider vinegar (ACV) gummy supplement. The website makes claims about weight loss, appetite control, blood sugar control, energy, immune function, detox, gut health, skin, and heart health. I chose to examine heart health.

The company used three studies to support the claim. The first examined the use of 750 and 1,500 mg of ACV in a drink. The results showed no clear pattern of benefit although triglycerides went down. The second study compared a group using ACV plus calorie reduction with a control group that had no intervention; in this case, the restricted calories could explain any benefits. Finally, they used data from the Nurses Health Study that reported better heart outcomes in women who used oil-and-vinegar salad dressing. The focus of that research was on the type of oil, not the type of vinegar.

Based on the FDA Guidelines, claims cannot be made from research that uses an ingredient in food as the substantiation for a benefit from a dietary supplement. I checked the research on several of the other claims they made and the research they used, and I came to the same conclusion. They may be very tasty gummies, but the research does not appear to support the claims they make. But if you want to take a gummy or two to reduce your appetite, our grandson Riley recommends sour gummy worms. Just FYI.

What are you prepared to do today?

        Dr. Chet

References:
1. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act. https://bit.ly/2QLDRa2
2. Biosci, Biotechnol, Biochem. 2009; 73(8):1837-1843.
3. https://doi.org/10.1016/j.jff.2018.02.003.
4. Journal of the American College of Nutrition, 2001; 20:1(5-19).

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