Amid a steady storm of negative news stories and lawsuits surrounding the labeling and/or safety of dietary supplements, the U.S. Food and Drug Administration (FDA) announced yesterday that it is creating the Office of Dietary Supplement Programs (ODSP). This move was pre-endorsed by a letter earlier this month from the trade associations representing the dietary supplement industry. The letter stated that the associations would endorse a reorganization of the FDA in an effort to bring more regulatory attention and oversight to the existing FDA’s supplements division.
Those associations who endorsed the new office include:
- American Herbal Products Association (AHPA)
- Consumer Healthcare Products Association (CHPA)
- Council for Responsible Nutrition (CRN)
- Natural Products Association (NPA)
- United Natural Products Alliance (UNPA)
And so, just 13 days after that endorsement, we have a new acronym: ODSP.
Just to be clear, there has been a division of supplements since the passage of the Dietary Supplement Health and Education Act (DHSEA) of 1994. Today, however, that division becomes its own office.
Here’s how that reorganizational change makes a difference. When the supplements division was established, it was placed within the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) under the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Dietary supplements were competing for resources and attention along with cosmetics and medical foods. That was when the dietary supplement industry was in the single-digit billions in annual sales. The last estimate, according to the Nutrition Business Journal in 2014, was $35 billion.
And between its inception and now, there have been some stunning headlines and happenings in this largely self-regulated industry.
In November 2015, a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements resulted in civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as such. USPlabs LLC and several of its corporate officers were criminally charged for their popular workout and weight loss supplements selling under names such as Jack3d and OxyElite Pro. In the last year alone, the FDA has warned of more than 100 products found to contain hidden active ingredients, including sibutramine (an active pharmaceutical ingredient in Meridia, a drug approved by the FDA in 1997 for prescription treatment of obesity and removed from the market in 2012 because of risks of heart attack and stroke), lorcaserin (an active pharmaceutical ingredient in the currently marketed prescription drug Belviq for chronic weight management but comes with regulated label warnings for serious side effects), BMPEA and DMBA, as well as pure powdered caffeine. Many of these increasingly scrutinized products are marketed for sexual enhancement, weight loss and bodybuilding.
Also in 2015, five nutritional supplement manufacturers were sent warning letters concerning the use of picamilon as an ingredient, including GNC Holdings Inc. and Vitamin Shoppe Inc. The issue with picamilon is that it’s not a dietary supplement, but a unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid. It’s absorbed into the body, crosses the blood-brain barrier and accumulates in the brain as a separate chemical entity. In fact, picamilon is used as a prescription drug in Russia for neurological conditions, but is not approved as a drug in the U.S.
The Federal Food, Drug and Cosmetic Act defines a “dietary ingredient” as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract or combination of preceding substances. It’s not a prescription drug regulated by the FDA and requiring clinical trials and reported findings for evaluation as safe and efficacious.
So why would a trade association that represents dietary supplements endorse more regulation? Because, like any industry, it costs a lot of money to legally manufacture, sell and label products, as well as to support the growing number of non-governmental organizations (NGOs) that help manufacturers adhere to sets of standards in their own effort to self-regulate.
More regulatory attention on the fast-growing dietary supplements industry might sound ominous, but it’s not really going to change much…unless you have no idea who makes the products you take, what’s in them and how safe they are.
Chances are if you’re reading this article from LivingHealthy, you’re an informed consumer. That is our very purpose in these times when consuming goods for health benefits has become our #1 obsession. And that’s a great thing.
The downside: rogue manufacturers and marketers trying to cash in on the latest fads in what is still an unregulated industry. And that just ticks us off. Why? Because we’re thrilled that we can make our own choices about what vitamins, minerals, herbs, fruits and vegetables to ingest (in the forms we like to buy them in)—and we don’t want to have to pick them up at a pharmacy in the future and need health insurance drug benefits to afford them.
Take, for example, the natural fish oil cholesterol-lowering prescription drug a pharmaceutical company tried to market several years ago that cost $250 a month versus available non-prescription, over-the-counter fish oil dietary supplements at an average of $30 a month. The clinical studies were sufficient to prove efficacy and get the supplement approved as a prescription drug, but the same data was not able to convince the insurance companies that they should foot the bill. Albeit a class of chemicals called statins is approved for cholesterol-lowering by health insurance drug plans. As consumers we’re told to tell our doctors if we are taking natural supplements like fish oil along with our statins.
From our perspective, the differentiation between what is a regulated drug and what is an unregulated dietary supplement is not clear-cut because many of us these days take both in our efforts to keep our bodies as healthy as possible. One thing is for sure—anything we ingest can have potent effects on our bodies, whether positive or negative. We are supposed to read all that printed information about our prescription drugs. But the challenge with the unregulated dietary supplements industry right now is that if the labels are false, misleading or simply a sin of omission, then consumers must be wary of the risks that no one even told us about. Imagine diving into a swimming pool marked 10 feet, only to find out it was mislabeled and is only 1 foot deep.
So what’s the net-net on this status change at the FDA supplements division?
The FDA says “the new ODSP will continue to work with FDA’s Center for Drug Evaluation and Research to help remove from the market products falsely labeled as dietary supplements that contain potentially harmful pharmaceutical agents, enforce the dietary supplement good manufacturing practices (GMP) regulation and take action against products that pose risks for consumers or are part of fraudulent economic schemes.”
This will help in getting more resources and attention focused on false claims and dishonest practices and halting the sales of chemically synthesized ingredients that can have serious and known side effects, especially around claims for weight loss, muscle building, energy and sexual enhancement. But don’t count on the government to start regulating your garlic, maca, magnesium, melatonin or zinc anytime soon. Could that day be coming? Perhaps, and we will keep you posted. Just consider this: It took consumer groups, and not the U.S. government, to finally convince Johnson & Johnson to take formaldehyde, a known skin irritant and occupational carcinogen, out of their baby bath and body products after 50 some years.
So don’t just sit back and breathe a sigh of relief. Sign up for our newsletter and visit our site again and again, because living healthy takes more than motivation—it takes knowledge, and you’ll get the straight facts here.
- FDA: FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership
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- U.S. Food and Drug Administration: FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership
- The Wall Street Journal: FDA Sends Warning Letters to Five Supplement Makers
- LivingHealthy: Your Cosmetics May Soon Be FDA-Regulated (and Safer)
- Environmental Working Group: Johnson & Johnson Cleans Formaldehyde Out of Baby Products, Moving to Adult Goods