example of adulterated and misbranded drugs

Baldemor, Lorraine Gaile A.

Rivera, Rein Casey C.

Ph. Jurisprudence

Adulterated and Misbranded Drugs

USPlabs’ OxyElite Pro has been linked to high risk of liver damage, according to a Nov. 6 FDA letter to USPlabs

which noted as many as 58 percent of liver illness patients identified by the Hawaii Department of Health had taken OxyElite Pro – and 63 percent of those said this was the only supplement they taking.

The FDA noted similar cases in a number of other states as well. 

Source: “USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses,” FDA News Release (Nov. 10, 2013), www.fda.gov/NewsEvents/…/ucm374395.htm (emphasis added).

Adulterated and harmful OxyElite Pro sports supplement forced off market by FDA

Making unauthorized drug claims about supplements by claiming that it can prevent, treat, or cure diseases.

During recent inspection, officials found that the company had “continued to make illegal claims that cause their products to be misbranded drugs”

“Using these products in the mistaken belief that they will cure a disease- especially when they cannot do so- represents a danger to the public’s health”

Global Biotechnologies supplements seized over unauthorized disease claims

http://www.nutraingredients-usa.com/Regulation/Global-Biotechnologies-supplements-seized-over-unauthorized-disease-claims?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright

R.A.3720 -Section 11a

The manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded.

Section 11a of R.A. 3720 as amended:The manufacture, importation, exportation, sale, offering for sale distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded.

R.A.9711 -Section 10

R.A.3720 -Section 11b

The adulteration or misbranding of any food, drug, devices, or cosmetic.

Section 11b of R.A. 3720 as amended:

The adulteration or misbranding of any health product.

R.A.9711 -Section 10

R.A.3720 -Section 19a

If its labeling is false or misleading in any particular.

R.A.3720 -Section 19j

If it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof.