US Supplement Market Regulation: Depression Claim, Undisclosed Drug, COVID Tincture

Source : 'HBW Insight'

A common type of noncompliant dietary supplement, one spiked with an erectile dysfunction drug, is being recalled in the US while depression is the latest health condition regulators say some marketers are claiming their supplements treat.

Depression and other mental health disorders likely are more common as the COVID-19 pandemic continues having impacts on US consumers, said Steven Tave, director of the Food and Drug Administration’s dietary supplement programs in a 19 February announcement of warning letters to 10 firms.

However, supplements labeled or marketed with claims to treat or prevent mental health disorders are unapproved and misbranded drugs. Consumers using products falsely advertised to prevent or treat physical or mental health disorders put themselves at risk by not seeking proven treatments from health care providers.

“This is especially concerning during the ongoing pandemic, when consumers are even more susceptible to depression and mental health issues,” said Tave, who has announced he is moving to another post at the FDA in March. ()

Enlifta's namesake brand supplements were among the products the fda recently identified as unapproved new drugs due to claims for treating depression.

The agency on the same day also announced that a Wisconsin veterinarian is the latest business that it warned about making false claims for treating or preventing COVID-19, bringing to 146 the number of firms the FDA, sometimes working with the Federal Trade Commission, has linked to coronavirus-related fraud. The FTC’s total, including its joint warnings with the FDA, is 392.

A 16 February warning to Dr. Paul's Lab in Mazomanie, WI, which the letter identifies as a veterinary practice, states that on 28 January FDA officials found on its website a product branded as “COVID-Aid Tincture” and labeled with directions for use of “take 1 cc (1 dropperful) under tongue 4–6 times daily until symptoms subside.”

The warning also stated that Dr. Paul’s website referred consumers to the website of a second Wisconsin veterinarian, Dr. Sarah’s Essentials in Arcadia, for sales.

A day earlier, the FDA announced the recall of a product labeled as a supplement but found to have one of, if not the most common violations in the US supplement market: it contained an undisclosed ED drug.

 A firm identified as “Adamssecret.co” began a recall of all lots within expiry of its “Adam’s Secret Extra Strength” 1500 and 3000 capsules after an FDA laboratory analysis found the products contained undeclared sildenafil or tadalafil, both phosphodiesterase inhibitors that are approved in the US as active ingredients for an ED indication.

Sildenafil and tadalafil are ingredients in FDA approved products for the treatment of male erectile dysfunction in the family of drugs known as. The presence of sildenafil and/or tadalafil in Adam’s Secret Extra Strength products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

The products are only the latest of hundreds of drug-spiked supplements that have been recalled in the US or that have been discovered and stopped at ports of entry. But reports of spiked supplements, almost always with ED, weight loss or steroid drug ingredients, found in the US have slowed for several years. ()

Still, Philadelphia firm Wave Miami LLC in January tested the FDA's willingness to exercise its authority to order recalls of supplements by not acting on the agency’s request to recall its product labeled as a supplement but containing an erectile dysfunction drug. ()

Two of the 10 firms the FDA warned about promoting supplements as depression treatments – Enlifta LLC, Omaha, NE, and Blossom Nature LLC, Folsom, CA – offered their products on Amazon’s e-commerce platform as well as on their homepages while the others conducted sales on their own sites.

The claims that rendered the firms’ supplements unapproved and misbranded drugs under FDA regulations included this by Blossom Nature on its Amazon page, “Get the best treatment for depression, anxiety and stress with blossom nature’s St. John’s wort”; and this by Native Remedies, dba Silver Star Brands, Oshkosh, WI, on its website, "MindSoothe is ...formulated to relieve the symptoms of depression. ... without any of the harmful side effects possible with prescription medicine," according to the warnings.

The other businesses the FDA warned about violative claims for treating depression are:

FDC Nutrition Inc.

, Ontario, CA;

ProHealth Inc.

, Carpinteria, CA;

Dr. Garber’s Natural Solutions

, Santa Monica, CA;

Wholesome Wellness

, Portland, OR;

SANA Group LLC

, Springfield, MO;

Mountain Peak Nutritionals

, Beaverton, OR;

Lifted Naturals

, Kansas City, MO.

The two businesses the FDA states were selling products on Amazon could incur regulation by the e-commerce giant, too. In November, as the FDA announced undeclared drugs in supplements bought on its and other e-commerce platforms, Amazon Inc. told supplement firms that to continue offering their products on its site they must by February provide documentation showing they follow FDA’s requirements for labeling and good manufacturing practices.()

The requirements amazon is imposing on vitamin, mineral and supplement product marketers also could expose those companies to litigation filed by plaintiffs’ attorneys alleging the firms are misleading and harming consumers. ()

By Malcolm Spicer