False claims about health products

Derrick Aarons

Sunday, November 12, 2017

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YOU have probably heard the term 'caveat emptor' — buyers beware! Well, we should all beware of products that promise to improve our health and cure us of every medical condition with which we may be afflicted.

As the population of all countries increase, large numbers of people and groups of people have banded together to find new ways to make a living. Some do so by legitimate means, while others do so by trickery and deceit.

In fact, many individuals and companies have become ingenious in separating you from your money. One such way is promising you that an item, product or substance they have produced will fulfil your wants or your needs, or make you healthy without providing any evidence or proof that the item, product or substance has such an ability.

Paid actors and actresses on TV or in ads 'telling you how good the product has worked for them' is not independent, unbiased or acceptable proof of its benefit. This ploy is currently being widely used, especially within the area of health care.

Protecting the consumer

Good health care is expensive, and is often insufficiently funded by the government. Consequently, products that state they provide health benefits are often attractive to many people. With the expansion of the global marketplace, purveyors of such products advertise widely across many platforms, and individuals can order online and have the product delivered to them across country borders within days.

While the Food and Drug Administration (FDA) has a regulatory function in the USA to protect their consumers from potentially harmful food and drug products, most lower- and middle-income countries like Jamaica that are targets for such vendors do not have well-developed, consumer-protecting regulatory agencies. For those that do, these agencies are usually poorly funded and thus incapable of regularly and widely informing the public of their findings on the various products.

Warning letters

Recently, the US Food and Drug Administration issued warning letters to four companies selling products online, stating that they should desist from making claims about their products without providing any evidence. The products allegedly contained cannabidiol, which is a non-intoxicating component of the marijuana (ganja) plant. The companies claim that their product can prevent, treat or cure cancer.

Due to the established regulations in the USA, any selling of unapproved products with unsubstantiated claims of treatment is a violation of the Federal Food, Drug and Cosmetic Act, and therefore illegal.

The companies market cannabidiol online in a variety of forms, such as oil drops, capsules, syrups, teas, topical lotions, and creams. The warning letters were a part of the FDA's ongoing campaign to reduce health care fraud.

In April 2017, the agency had issued more than a dozen other warning letters to companies marketing bogus cancer cures. Cannabidiol is a component of the marijuana (ganja) plant and is distinct from tetrahydrocannabinol (THC), also present in ganja, which is intoxicating.

Tests being done

Cannabidiol is currently undergoing clinical investigation to ascertain whether it may be helpful in cancer treatment, but no confirmatory findings have yet been made. So, for example, GW Pharmaceuticals and Otsuka Pharmaceutical Company, currently, are conducting phase two and phase three research trials in the USA, to evaluate the safety and effectiveness of the product Sativex.

This product is a formulation from cannabinoid, and is being tested for the treatment of pain in patients with advanced cancer who have not obtained sufficient pain relief from long-term opioid treatment.

Claims about soy protein

The FDA is also considering revoking the health claim that soy protein reduces the risk of heart disease. This claim was first made in 1999, but since then numerous published research studies have presented inconsistent findings on the relationship between soy protein and heart disease.

A statement made by the director of the FDA's Center for Food Safety and Applied Nutrition informed that all the currently available scientific evidence on the matter calls into question any certainty regarding such a relationship.

The FDA uses a rigorous standard for any health claim, and once met, the agency authorises the release of the health claim subsequently to the public. Where the product only meets a lower scientific standard of evidence, any claim regarding health benefit must be qualified using language that informs about the limited evidence currently existing.

While the FDA in the USA commits to providing consumers with information they can trust to make informed dietary choices, many low resource countries have no such agency to assist in disseminating such knowledge to the public. Consequently — caveat emptor!

Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is the Ethicist at the Caribbean Public Health Agency - CARPHA. (The views expressed here are not written on behalf of CARPHA)




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