Regulatory Focus™ > News Articles > Warning Letter to Distributor Alleges Rare Trifecta of Drug, Supplement and Food Deficiencies

Warning Letter to Distributor Alleges Rare Trifecta of Drug, Supplement and Food Deficiencies

Posted 22 May 2013 | By Alexander Gaffney, RAC

More than a few Warning Letters sent by the US Food and Drug Administration (FDA) over the years have referenced products that tried to skirt regulation by presenting themselves to regulators as a different class or type of product. On the pharmaceutical side, this has often meant de-facto pharmaceutical products presenting themselves to the public as dietary supplements. But now a new Warning Letter alleges that a company has gone in the opposite direction, attempting to pass off a food product as a both a dietary supplement and marketing it with claims that render it an unapproved new drug, violating the regulations for all three.


The letter, sent 2 April 2013 to manufacturer Natures Health Options, references an inspection made in July 2012 at the company's Boca Raton, FL facility.

The majority of that inspection, and the Warning Letter, focus on one product, Charantea Bitter Melon Ampalaya, which the company distributes in both 500 mg capsule and tea bag forms. Both products are labeled as dietary supplements, FDA notes.

The letter goes on to note an unusual combination of claims that places the product in violation of regulations for food, dietary supplements and pharmaceutical products-simultaneously.

The most serious of the claims, from FDA's perspective, is that the products are being marked as having "blood sugar-lowering properties," making the product a drug under federal law because the claim is therapeutic in nature. Thus, without an approved new drug application, the product is in violation of 21 USC 321, FDA claimed.

Supplemental Problems

But "even if [Natures Health's] product is not an unapproved new and misbranded drug," FDA said the product was still in violation of the agency's current good manufacturing practice (CGMP) regulations, rendering the products adulterated.

The main problem, according to regulators, is that Natures Health neglected to create or keep written quality control procedures for its products. While the organization said it contracted out the actual production of the product to outside manufacturers, FDA said this does not mean the company can "contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce is not adulterated for failure to comply with dietary supplement CGMP requirements.

"A firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations," it added, citing the case of United States v. Park.

Supplement or Food?

The company, however, also stated on its website that the product was a "conventional food," according to FDA. Regulators noted the website claims the company's Charantea Ampalaya tea can be consumed as "a great alternative to coffee or traditional tea," as a "healthy after-meal beverage," or enjoyed simply as a "simple traditional tea."

Because 21 USC 321 defined dietary supplement as a product that is explicitly "not represented for use a conventional food," this, too, made the product misbranded.

"If you want to market your Charantea Ampalaya Tea as a dietary supplement," FDA wrote, "the product cannot be represented for use as a conventional food (nor, as stated earlier, promoted for conditions that cause it to be a drug) and, among other requirements, must meet dietary supplement CGMP requirements in 21 CFR Part 111."

In other words, pick a product category-not three.

Warning Letter to Nature Health

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