Healthful, or harmful?

These statements have not been evaluated by the FDA

By Sarah Sidlow

The recent death of a 25-year-old Australian bodybuilder has many wondering about how far the government should go to inform people about dietary supplements. Meegan Hefford, a bodybuilder and paramedic trainee, was found unconscious in her home, and rushed to the hospital, where she was later pronounced brain dead and passed away. Her death certificate cites “intake of bodybuilding supplements” and an undiagnosed illness as the cause of death. Reports indicate Hefford was on a strict high-protein diet (including multiple protein shakes a day) and intense workout regime in preparation for an upcoming bodybuilding competition. But she didn’t know that she had a rare, undiagnosed condition called urea cycle disorder—which prevented her body from breaking down protein, leading to high levels of ammonia in the bloodstream and excessive fluid on the brain.

After her daughter’s death, Hefford’s mother discovered half a dozen containers of protein supplements in her kitchen. Now, Hefford’s family wants more to be done to regulate the sales of protein shakes.

Let’s talk about dietary supplements here in the U.S.

The Food and Drug Administration (FDA) defines dietary supplements as “a product intended for ingestion that contains a ‘dietary ingredient’ intended to add further nutritional value to (supplement) the diet.” Those dietary ingredients could be: vitamins, minerals, herbs, amino acids, extracts, concentrates or other dietary substances that increase the total dietary intake (like protein). Reports indicate that about 71 percent of American adults take dietary supplements each year—the biggest population of supplement users: hello, Millennials. Oh yeah, according to the Council for Responsible Nutrition, it’s also a $120 billion business.

Such a big business is probably heavily regulated, right? Wellllllll…

Dietary Supplements are currently regulated by the guidelines outlined in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Here’s the quick takeaway: the DSHEA defines dietary supplements as food, not drugs. That means supplements don’t have to go through the same process as new pharmaceuticals to get approved by the FDA. This spares manufacturers the time and economic resources needed to successfully pass the rigorous new-drug protocol. But that doesn’t mean supplements aren’t regulated.

For one, the FDA still regulates product labeling. That means whenever a marketer wants to make a claim about a supplement, it still needs the FDA’s approval. DSHEA also holds supplement manufacturers to “good manufacturing practices”—industry standards for maintaining product quality.

For many, including the Alliance for Natural Health, the DSHEA is more than enough to regulate dietary supplements. In fact, they argue that the FDA has not implemented the DSHEA to its full extent, which has led to a false perception among the public that dietary supplements are unregulated.

Moreover, there will always be those in favor of less government oversight; for everything; ever.

But others, like Hefford’s family, believe an ounce of prevention is worth a pound of cure. For starters, they argue manufacturers can put virtually whatever claims they want on a product, as long as they also include the phrase: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” Opponents also argue the DSHEA doesn’t require manufacturers to standardize active ingredients or meet purity guarantees in multi-chemical products. And most importantly, they argue that there is little ability for the FDA to issue recalls and cease-sale orders until significant problems have been identified—which isn’t very helpful.

It may be fair to argue that a little FDA sticker or warning wouldn’t have stopped someone like Meegan from using (or overusing) a dietary supplement. But as dietary products continue to flood the market, it’s important to understand how they got there, and what hazards they may present.


Debate Forum Question of the Week:

Are the current FDA regulations on dietary supplements sufficient?


Regulations can’t supplement research

Personal responsibility makes us safer than government regulations

By Don Hurst

Recently, I fell down the fitness supplement rabbit hole. Serving in the law enforcement and military communities since 2000, I’ve been around a lot of type A personalities ingesting powders to gain an edge, but I never partook myself. It was my impending 40th birthday that pushed me to the supplement store. Injury from my last deployment and the unceasing click of the clock hands towards incontinence and senility necessitated stronger measures than grilled chicken breasts and kale smoothies.

I quickly learned stores stock an overwhelming variety of supplements, but my mom raised me right. As a child she would not allow me to pick up random things off the floor and eat them. That habit stuck with me as an adult.

Armed with my iPhone and the encyclopedic knowledge of the Internet, I entered the supplement store and began Googling such things as: histidine, teacrine, betaine anhydrous, and all kinds of other crap that sounds made up. That may seem like overkill but I did not want to rely on the college kid working the counter and the store’s fear of litigation to keep my heart from exploding. 

Google retrieved dozens of websites, including the FDA’s, that published articles on the risks and benefits of supplements. In less than ten minutes I found enough information to make an informed decision about what to buy. I weeded out the legal powders that carried risks I found uncomfortable and selected the products that met my goals without liquefying my liver.

People do die from supplement misuse, just as people die from artery hardening Big Mac misuse. A common military deployment stereotype is that 18-year-old private living solely on Monster energy drinks and Rip-its. They drink ten a day and wonder why they have headaches and glow in the dark urine. I had a cop buddy who went to Mexico once a year to buy a year’s supply of U.S. banned pre-workout powder he dubbed the “Bandito Bam Bam” that eventually gave him man breasts.

That all sounds scary, but the supplement market is not the Wild West-anything-goes environment that regulation supporters claim. Sure, the FDA currently doesn’t possess the authority to inspect products prior to release, but if concerns arise they can test the products, pull them from the shelves, and prohibit their sale in the U.S. The current regulations are enough.

Expanded regulations would not have saved the life of the British bodybuilding mother. The FDA has allowed the sale of protein powders for decades because when used as directed they are safe. Her use went far beyond what most people would call reasonable. Living on a diet consisting solely of protein powders and egg whites is not healthy.

That’s not an unknown fact. Guidelines on maximum protein intake and balanced diet recommendations are widely available. People need to make smart decisions about what they put in their bodies. Perhaps it is too much to expect people to do their own research and take responsibility of their choices. Allow me to suggest a third path, a compromise between the status quo and intrusive FDA regulation.

The FDA could work with the supplement industry to create a voluntary screening program. Companies submit products for testing. The FDA examines the ingredients to insure purity and ingredient composition. Based on the potency of the formula, they place a warning label on the package and an FDA stamp of approval. 

A program like that would give consumers even more information without telling them what they can or cannot buy. Then the free market would decide if it benefits companies to offer up their products for testing.

As a society, we have clamored for the government to give us all the answers. Our abdication of personal responsibility resulted in a confusing inconsistent mess of regulation. Just because the government says something is legal to put in your body doesn’t mean it’s good for you. Trans fats, alcohol, nicotine – all legal.

The government does not make a good final arbiter. We get better results if we do our own research.

Don Hurst is a combat vet and a former police officer. He now lives in Dayton where he writes novels and plays. Reach DCP freelance writer Don Hurst at DonHurst@DaytonCityPaper.com.


Let the FDA do its job

Regulate companies that have killed people

By Ehron Ostendorf

The FDA is defined as “The Food and Drug Administration—a federal agency of the United States Department of Health and Human Services.” Health and human services means that their job is to regulate food and drugs that are created by companies.

When companies are created and want to administer food items, what’s stopping them from making them poisonous? Of course, if they poisoned food, they’d go to jail. Why and how? Well, the government would charge them. And there it is. The government, and what government agency dictates whether food is safe or unsafe? The FDA. Now, forgive me if I’m skeptical, but companies often don’t care about our health; they care about the bottom line. Nestlé is a prime example.

Nestlé was the company that introduced a baby formula to areas in Africa in the ’70s. What’s wrong with that? You need water to mix the formula, and they introduced this formula to areas that had limited clean water. Second, they gave the women a “free trial” long enough for their natural milk to dry up. They grew dependent on the formula. Third, the women didn’t have enough money to buy this formula when they were dependent on it, so they were diluting the formula, which resulted in many unnecessary children’s deaths.

In that situation, do you blame the women for not “doing their research,” or do you blame the company for not doing theirs? I blame the company. But how would I, an individual, reprimand a company on my own? I wouldn’t be able to do a lot on my own. But, if you have an entire organization backed by the U.S. government, they might be able to get more traction and use the law of the land to nail companies that are harming us.

As a consumer, I’m responsible for researching my own food, which I do. I’m a supporter of organics and non-GMOs. I’ve supported those things for years—far before they became a fad. I’ve also been a big proponent of keeping corporations accountable far before it became a fad in the 2016 election. So I agree that consumers are responsible for researching their own food. Food distributors are not responsible for teaching you that bread is a carb and a candy bar has sugar. Consumers should know better.

I also understand that bureaucracy and government organizations should not control aspects of our lives, but this is not whether the FDA should choose what we eat—it’s about whether they should have the right and power to introduce more regulations on companies that are providing food, drugs, etc.

I’m also busy like many of us and that means that sometimes, I don’t have time to read every lengthy ingredient list for every item I throw into my cart. A grocery trip would take me three hours to complete if I read every single label. Beyond that, who’s to say a company won’t lie? Sometimes, there’s a very convenient “and other ingredients” on the back of containers, bottles, or packages.

What are those “other things”? Unsurprisingly enough, I don’t have time in life to launch a full investigation of those said “other items” and grab a camera to go to these facilities and discover just what people put in their food. Should I do that to every item? No! Then how do I know my food is being protected? Who investigates what I eat since I don’t have time? Surprise, it’s the FDA.

Companies can change their ingredients how they see fit and consumers aren’t always aware of those changes—we buy things and assume that since those items on a shelf, they’re safe to consume. Isn’t that what everyone does? Then, a convenient story surfaces about E. coli in our spinach. Or maybe a cow farm had an outburst of mad cow disease.

Whatever the case, the FDA are the ones to send experts to investigate and research this. Then we see on the news that they deemed something unsafe, and they prosecute the company for mishandling their items.

If we want the FDA to “back up” and leave consumers to do their own research and to also leave these companies to conduct their business, won’t this just happen again? Who’s to stop it from reoccurring if not the FDA? The FDA’s job is to ensure a consumer’s safety, so maybe they need to step in and increase their regulations. Apparently, this last company didn’t sufficiently test their product since Meegan Hefford lost her life as a result of their stupidity and inefficiency.

Reach DCP freelance writer Ehron Ostendorf at EhronOstendorf@DaytonCityPaper.com.

Tags: , ,

Don Hurst
Don Hurst is a combat vet and a former police officer. He now lives in Dayton where he writes novels and plays. Reach DCP freelance writer Don Hurst at DonHurst@DaytonCityPaper.com.

No comments yet.

Leave a Reply

Law & Disorder: The Docket 9/19

L&D

Major key Last weekend a local couple was watching TV in their living room, having a relaxing evening, when suddenly […]

Law & Disorder: The Docket 9/12

L&D

Jesus take the wheel A local couple recently decided to visit their church on a particularly warm and muggy Sunday […]

Law & Disorder: The Docket 9/5

L&D

Flightless In a local park, police were dispatched to the crime scene. A woman called the police when she realized […]

The Docket: 8/29

285_2697643

Stolen in a nanosecond Just last week a woman visited her local sheriff’s office to place a tip on a […]

Law & Disorder: The Docket 8/22

L&D

Totally secure knot …not In a local home a garage door was broken into. This garage door was perfectly secured […]