FDA Warning Letters

Maine Natural Health Is FDA-Warned For Quality Control, False Claims

Harold Leighton and his company, Maine Natural Health, have been formally warned by the¬†U.S. Food and Drug Administration, or FDA, for what the agency alleges are multiple and “significant” violations related to some of the company’s supplements and whey protein products.

In the letter, FDA called Leighton out for his use of non-allowed marketing spiel in his answering of customer questions on the company’s website. Maine Natural Health was asked, for example, about using its SO3 Fish oil product for a toddler’s eczema. The company’s answer is, in the opinion of the FDA, not allowed because it suggests that the product could actually treat a disease:

FDA says Maine Natural Health violated regulations by suggesting its SO3 fish oil product could treat a skin condition.

An example of how answering a consumer’s question about its SO3 Fish Oil supplement got Maine Natural Health in hot water with FDA inspectors.

And, as you might expect, it wasn’t just answering people’s questions that got the company in trouble. A “wellness brochure” holds promotional spiel that also got the FDA’s hackles up. In it, the company suggests that its Pure Whey Protein product can directly treat inflammation and obesity while indirectly preventing conditions as serious as diabetes, heart disease and even cancer:

FDA warns Maine Natural Health over is whey protein product.

A page from the company’s “Wellness Brochure” which FDA says promotes a whey product for serious medical conditions.

But even aside from the troublesome claims made on the company’s website and its products’ labels, Maine Natural Health is still in the agency’s cross hairs for lax quality control. During 3 multi-day inspections last spring, FDA inspectors determined that the company did not develop¬†identity specifications for raw ingredients, failed to develop purity specifications for raw ingredients and neglected to declare and implement quality standards for finished products. And that, says FDA, makes some of Maine Natural Health’s products “adulterated”.

Allegations Of False Claims

The warning letter, which was redacted in spots, also alleges that some products are marketed with false and/or misleading claims. Some workout supplements, for example, claim to have “powerful antioxidant properties” but the ingredients cited do not actually act as antioxidants.

Also, two whey products make un-allowed claims of being “low cholesterol”. In fact, says FDA, they do not meet the established criteria for such a claim.

The FDA warning letter to Maine Natural Health was dated December 19, 2017 and gives the company the normal 15 working days to address the alleged violations. As you can see from our screenshots, which were captured today, the company has not yet removed all the cited verbiage from its website.