Revamping the FDA: Do We Need More or Less Regulation?

Chances are you’ve seen the ubiquitous FDA disclaimer on your supplement bottles telling you that, “these statements have not been evaluated by the Food and Drug Administration…”

...or perhaps you’ve wondered what “FD&C Green #3” means in your favorite candy ingredient list. Either way, if you live in the United States, you are impacted on a daily basis by the FDA and its regulations.

So, what is the FDA? Officially called the Food and Drug Administration, this federal agency is part of the United States Department of Health and Human Services.

The main focus of the FDA is to enforce the Federal Food, Drug, and Cosmetic Act (FD&C), a group of laws passed by Congress in 1938 that gives the FDA authority to oversee safety of food, drugs, and cosmetics—and amendments over the years have expanded the coverage to include other products as well.

Nowadays, the FDA works to protect public health by regulating the safety and efficacy of a variety of substances, including foods and beverages, dietary supplements, pharmaceutical drugs, cosmetics, tobacco products, vaccines and other biologics, medical devices, radiation-emitting electronic devices, and veterinary products.

The FDA regulates an astonishing $1 trillion in consumer goods products—that’s nearly 25% of U.S. consumer expenditures each year! It’s clear that regulation of some sort is imperative, but how much is too much...or too little?

New Leadership May Mean New Regulations

With the changing political climate and new appointments to crucial agency posts, we are in the midst of a great debate about how much the FDA should really regulate. The new administration vows to slash up to 80% of FDA regulations, but is this really the best plan for our health and safety?

Here’s a look at some of the pros and cons of reducing FDA regulations:

Pros

• Dietary Supplements. Because supplements are regulated as foods rather than as drugs—and they don’t go through the same approval process as pharmaceuticals—supplement manufacturers can’t make any unapproved health claims about their products that could potentially help consumers.

How does this affect you? Let’s say you’re looking for a natural method to treat a health condition. Because makers of supplement XYZ can’t say they treat or cure that condition per FDA regulations, you may have a hard time locating this product, even if it is the best (and safest) treatment for what ails you. If these regulations were loosened, it’s possible that dietary supplements could carry health claims that encourage consumers to choose healthier options.

• Innovation. Advocates of more lenient FDA regulations argue that less red tape and bureaucratic involvement could pave the way for innovative products and technologies that would benefit consumers and decrease costs for pharmaceuticals, nutraceuticals, medical devices, and medical care. Right now, it can take 3-4 years longer to get a new product to market in the United States than in Europe, leaving patients here unable to benefit from potentially life-saving devices and treatments.

• Alternative Treatments

- Fecal Transplants. Transferring stool from a healthy donor to the colon of a person struggling with an invasion of inhospitable microbes (often due to antibiotic use) can be a lifesaving procedure with no adverse effects and a 94% success rate.1 Although this is much higher than the 31% efficacy of standard antibiotic treatment—which leads to growth of even more bad guy bacteria—patients often have a hard time finding a doctor who will agree to the procedure.

The problem is that the FDA still considers fecal transplants Investigational New Drugs, and as such, doctors and clinicians must get FDA authorization before utilizing them. And, the FDA is tightening regulations even further, requiring that transplant recipients or the clinician in charge of treatment must know the donor, which limits the use of stool banks. Looser FDA regulations could mean easier access to this procedure that yields almost miraculous results.

- Stem Cells. Stem cell therapy—using the body’s stem cells to treat various conditions—is an exciting new frontier in medicine that can have wide-ranging applications.2 Because stem cells can divide and become many different types of cells within the body, the possible uses for this regenerative therapy are seemingly limitless. However, the FDA has only approved blood forming stem cells for certain medical situations, leaving many people who could benefit from the procedure having to travel internationally or forego the therapy altogether.

Obtaining FDA approval through clinical trials is a long, arduous, and expensive process, and unfortunately, many people don’t have the luxury of time to wait for the therapy. More relaxed regulations could make potentially life-saving treatments and alternative therapies more accessible to the people who really need them.

Cons:

Pharmaceutical Drugs. An incoming FDA Commissioner may push for an accelerated, progressive approval process for new prescription drugs, requiring companies to prove safety, but not effectiveness, before FDA approval. While the approval process can take years, fast-tracking drugs to the market without extensive research can have dangerous consequences for patients.

Critics of deregulation point to the 1960s thalidomide crisis, where mothers who took the sedative drug during pregnancy later gave birth to babies with severe birth defects. Fortunately, the FDA did not approve thalidomide’s use in the United States, and the worldwide health crisis led to amendments requiring companies to scientifically prove that a drug is safe and effective. Getting rid of this part of the regulatory process could open the door to some harmful drugs.

Self Regulation. Any time we take away an agency’s ability to regulate an industry, the responsibility falls to the industry itself and this isn’t always a good thing for consumers, especially when the bottom line could potentially trump the importance of our health and well-being.

If, for instance, a pharmaceutical company sees a big potential profit with a new drug, they may rush it to market without adequately testing its long-term side effects. The fact of the matter is that, without strict FDA regulations when it comes to drug approvals, consumers may not be adequately protected.

What's more, even under an administration with strict rules and enforcement, some companies make profit-based decisions that are decidedly not in the best interest of public health. Take, for instance, the recent Environmental Protection Agency (EPA) scandal, where an EPA pesticide division manager collaborated with Monsanto to allegedly "kill" the agency's investigation into the toxicity of the company's weed killer (Roundup), despite evidence that it can cause serious health issues. What happens when there is even less regulation?

• Food. In 2011, President Obama signed the Food Safety Modernization Act. This bill called for a much-needed increase in food safety programs and the FDA’s ability to conduct inspections, recall tainted products, and oversee farming practices, all in an effort to protect consumers from unsafe foods after an era of seemingly endless food safety concerns—like the 2008 Salmonella contamination of tomatoes and peppers.

Unfortunately, the current administration has vowed to eliminate FDA regulations that focus on food safety and hygiene. We often take for granted that the food we eat is safe and not contaminated with bacteria that can lead to serious complications, but less FDA regulations when it comes to our food supply could have devastating consequences on our overall health.

How to Be a Conscious Consumer

As a country, we are at a crossroads in more ways than one, and changes in the FDA and its regulatory processes are inevitable as power shifts hands. The question becomes, what can you do to protect yourself and your family in the face of all these changes?

1. When it comes to dietary supplements, do your research and look for companies that adhere to GMP regulations and use third party laboratory testing to ensure purity. By only taking supplements from companies you trust, you’ll be well on your way to safe supplementing.

2. Take prescription and over-the-counter medicines only when absolutely necessary—and opt for natural alternatives whenever possible—to limit your exposure to new drugs that may not have enough scientific backing to be truly safe in the long-term. And try to stay away from antibiotics, which indiscriminately wipe out all your good bacteria, leaving you susceptible to inhospitable bacteria and a downward spiral of antibiotic use.

3. If the FDA cuts back on its food safety programs, you’ll have to go the extra mile to make sure the food you consume is safe, so know where your food comes from and choose natural, organic, and GMO-free whenever possible. Even better, eat seasonally and from local farms if you can—not only will the food taste fresher, but you’ll know what you’re getting directly from the source.

4. Do everything you can to build and nurture your microbiome, the foundation of your health and immune function. A healthy microbiome brimming with beneficial bacteria can work to protect you in the face of life’s physical and emotional challenges, including those that arise from toxins, chemicals, and unsafe and contaminated foods.3

While we likely can’t control what changes take place in the FDA in the coming years, we do get to decide how we react to them and what changes we can make in our own lives to ensure we are living our healthiest and happiest days. Combining a gut-healthy lifestyle with knowledge, research, and advocacy for your well-being is the key to conscious, vibrant living!

References:

1. Nood, E. V., Vrieze, A., Nieuwdorp, M., Fuentes, S., Zoetendal, E. G., Vos, W. M., . . . Keller, J. J. (2013). Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile. New England Journal of Medicine,368(5), 407-415. doi:10.1056/nejmoa1205037

2. Trounson, A., & Mcdonald, C. (2015). Stem Cell Therapies in Clinical Trials: Progress and Challenges. Cell Stem Cell,17(1), 11-22. doi:10.1016/j.stem.2015.06.007

3. Casey, P. G., Gardiner, G. E., Casey, G., Bradshaw, B., Lawlor, P. G., Lynch, P. B., . . . Hill, C. (2007). A Five-Strain Probiotic Combination Reduces Pathogen Shedding and Alleviates Disease Signs in Pigs Challenged with Salmonella enterica Serovar Typhimurium. Applied and Environmental Microbiology,73(6), 1858-1863. doi:10.1128/aem.01840-06

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Emily Courtney is a Writer and Editor at Hyperbiotics and mom to two fun and active boys. Emily is passionate about natural wellness and helping others learn about the power of probiotics for vibrant health! For more ideas on how you can benefit from the power of probiotics and live healthier days, be sure to subscribe to our newsletter.

Posted in Clean Living, Diet & Nutrition, Gut Health, Lifestyle


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