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It's Time to Rein in Big Herbal

Robert Nicholson is the founder and president of the ED Treatment Information Center, a resource for living with erectile dysfunction.

Herbal supplements are hailed as safe solutions to some minor medical issues. But are they really?

Herbal supplements are hailed as safe solutions to some minor medical issues. But are they really?

In recent years, many people have become very critical of the pharmaceuticals industry: “Big Pharma.” The industry is accused of policies that make much-needed and even life-saving drugs unaffordable for many people.

But there is another rapidly-growing business segment that is every bit as greedy and irresponsible as the pharmaceuticals industry: “Big Herbal,” the herbal supplements business.

What's Wrong With Big Herbal?

In the US, the herbal supplements business is very poorly regulated. The Food and Drug Administration (FDA) has limited authority to oversee supplements and does not have the resources to fully enforce the regulations that do exist. This has led to a truly pervasive pattern of abuses and illegal activities.

The abuses have grown so serious that fourteen US states and territories have formally petitioned Congress to regulate the herbal supplements industry [1].

False Claims

Before a prescription drug can be sold, it must undergo a series of clinical trials to prove that it is safe and effective. Drug companies can only make claims that have been proven, and they must disclose all known risks and side-effects.

Herbal products, on the other hand, are not tested for safety or effectiveness.

In theory, manufacturers cannot make specific medical claims regarding herbal supplements. For example, they cannot say that an herbal product will cure the flu (although they may say that it will “strengthen the immune system.”)

In practice, FDA rules have little effect. Supplement makers have learned how to skirt around the law by making vague statements, and in many cases make false claims. The great majority of health claims made for herbal products are simply not substantiated in any way.

As an example, the ED Treatment Information Center examined the claims for over a dozen herbal ingredients that are promoted as curing or treating erectile dysfunction [2]. Based on clinical research, not a single one of the ingredients has been shown to have a significant impact on erectile dysfunction... and many are known to have serious side effects that are not disclosed on the product packaging.

Mislabelling

Quality control among herbal supplement companies is incredibly bad.

A 2013 study found the half the herbal products tested did not contain the ingredients listed on the label [3]. Another study found that over two-thirds of the products tested had substituted other plant species for the plants listed on the label, and a third of products also contained other fillers or contaminants [4].

A study by the New York State Attorney General of herbal products sold at GNC, Target, Walgreens, and Walmart found that four out of every five products didn’t contain the ingredient they claimed [5]! At Walmart, the investigators found that its ginkgo Biloba, a Chinese plant promoted as a memory enhancer, contained little more than powdered radish, houseplants, and wheat — despite a claim on the label that the product was wheat- and gluten-free.

Contaminants

Many herbal supplements have been found to contain contaminants [4]. A review of FDA data identified almost 800 products that contained contaminants, including allergens, steroids, and pesticides [6].

Unlisted ingredients and contaminants can cause serious adverse health effects. One study found that dietary supplement use was associated with 23,000 emergency department visits and 2,000 hospitalizations in the United States each year [7].

Doctors are responsible for discussing side-effects of prescription medications with their patients.  There are no such protections for herbal products.

Doctors are responsible for discussing side-effects of prescription medications with their patients. There are no such protections for herbal products.

Serious Side Effects

When doctors prescribe FDA approved medications, they make sure that the drugs won't have an adverse impact on underlying medical conditions, if any. They also check to be sure that the drug won't cause dangerous interactions with other drugs you may be taking.

Your doctor will also talk with you about potential side-effects. Information on side effects must also be included in the packaging for the medication.

When you buy herbal supplements, you have none of these protections!

Even if you are lucky, and the product actually contains the ingredients it claims (and no contaminants), it can still pose a danger to your health.

Many people believe that “natural” is synonymous with “safe.” This could not be further from the truth! Natural ingredients can have serious health effects [8].

For example, yohimbe - frequently recommended to treat erectile dysfunction - may cause increased blood pressure, fast or irregular heartbeat, anxiety, insomnia, and kidney damage [2]. It may also interact with blood pressure medications or anti-depressants.

Conclusions About Herbal Supplements

The herbal supplements market is expected to grow to $729 billion by 2026 [9]. It is an industry that is built on complete disregard for the welfare of its customers.

An objective look at the herbal products business paints a frightening picture:

  • Herbal products are routinely marketed based on false claims about their effectiveness and safety
  • More than half the products are mislabeled and don't contain the ingredients listed
  • In hundreds of cases, herbal products have been found to contain dangerous contaminants
  • Even “natural” products can pose serious health risks, and they are sold with no warnings or medical advice

Whether or not you are a proponent of herbal supplements, it's clear that "Big Herbal" is an industry that is out of control, and needs to be regulated to protect the health and safety of consumers.

Until there is effective oversight of this business, think twice before buying herbal supplements... unless you happen to have access to a laboratory to determine what you are really getting!

References

[1] "A Communication from the Chief Legal Officers of {fourteen} States and Territories," April 2015.

[2] "What You Should Know About Natural Herbal Remedies for Erectile Dysfunction." ED Treatment Information Center. March 2018.

[3] Newmaster, Steven G.; Grguric, Meghan; Shanmughanandhan, Dhivya; Ramalingam, Sathishkumar; and Ragupathy, Subramanyam. “DNA Barcoding Detects Contamination and Substitution in North American Herbal Products.” BMC Medicine. 11/2013:222.

[4] Wise, Jaqui. “Herbal products are often contaminated, study finds.” British Medical Journal. Oct 2013. DOI:10.1136/bmj.f6138.

[5] "What's In Your Herbal Supplements? DNA Barcoding Identifies Houseplants and Wheat." Popular Science Health. February 2015.

[6] Tucker, J; Fisched, T. Upjohn, L. “Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings.” JAMA Network Open. Oct 2018.

[7] Geller, AI; Shehab, N; Weidle, NJ. “Emergency department visits for adverse events related to dietary supplements.” New England Journal of Medicine. Oct 2015. 373:1531-1540 DOI: 10.1056/NEJMsa1504267/

[8] Ekor, Martins. "The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety." Frontiers in Pharmacology. January 2014.

[9] "Herbal Supplements Market Global Size." Acumen Research and Consulting. December 2018.

This content is accurate and true to the best of the author’s knowledge and does not substitute for diagnosis, prognosis, treatment, prescription, and/or dietary advice from a licensed health professional. Drugs, supplements, and natural remedies may have dangerous side effects. If pregnant or nursing, consult with a qualified provider on an individual basis. Seek immediate help if you are experiencing a medical emergency.

© 2021 Robert Nicholson

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