Misbranding

The conditions whereby dandmff, seborrheic dermatitis, and psoriasis dmg products are generally recognized as safe and effective and are not misbranded is available (70). Specific active iagredients that can be used as well as the statement of identity, iadications for use, and required warnings, are identified. Products that do not meet all of these requirements are considered new dmgs and must have an approved NDA for the nonmonograph conditions. 

FDA s medical device regulations relating to adulteration and misbranding generally apply to devices intended for use on animals. These devices, however, are exempt from the 510(k) and PMA requirements. FDA has viewed animal grooming products as being outside of its purview. 

The use or presence of poisonous or deleterious substances in cosmetics and dmgs is prohibited. The presence of such materials makes the product "adulterated" or "misbranded" and in violation of good manufacturing practices (GMP), which ate appHcable to dmgs and, with minor changes, to cosmetics (6). 

The legal status of dairy substitutes varies widely among countries. In the United States, the FDA has held that filled products should be nutritionally equivalent to the products they resemble. In the case of imitation milks, the FDA proposed regulations for nutritional equivalency (31). A section of the Food, Dmg and Cosmetic Act defines misbranded foods, and the FDA has set up standards of identity for foods under this part of the law (32) which includes standards for imitation milks, cheese, and creams (32). 

The original Food and Drugs Act is passed prohibiting misbranded and adulterated food and drugs. 

Sale of a deficient or misbranded economic poison is a violation of law, for which the seller is subject to prosecution as a misdemeanor. The maximum penalty is a fine of 500 or 6 months in jail. Repeated violations are cause for revocation of registration. This is a very drastic penalty and is seldom required. 

Eliminated Sherley Amendment requirement to prove intent to defraud in drug-misbranding cases... 

Good manufacturing practices (GMPs) ensure that products meet specific quality standards, are not adulterated or misbranded, and contain the correct ingredients and doses stated on the label. GMPs specifically for dietary supplements are being proposed from the FDA. Cases of adulteration have been reported to the FDA, and examples include a plantain product adulterated with digitalis and hibiscus tea adulterated with warfarin [29]. 

If a pharmacist posted a sign in a pharmacy claiming a dietary supplement is effective in treating or preventing a certain disease, the pharmacist would be violating the FDCA. The product would be considered a drug but not properly labeled as a drug and therefore would be misbranded. 

Passage of Pure Food Act, including provisions for the regulations of drags to prevent the sale of misbranded and adulterated products. Enforcement by the Chemistry Laboratory, Agriculture. 

A. Surveillance and compliance actions involving general controls violations, such as misbranded or adulterated devices, under Sections 301, 501, and 502. 

General conditions for general recognition as safe, effective, and not misbranded Over-the-counter drug products intended for oral ingestion that contain alcohol... 

Government concern about the adulteration and misbranding of pharmaceutical products extends back to ancient times.Pliny the Elder, for example, in the first century ad, criticised the fashionable druggists shops which spoil everything with fraudulent adulterations. As a result, various forms of government control to prevent the adulteration and misbranding of... 

Under the FD C Act as enacted in 1938, adulterated and misbranded drugs may lawfully be exported but an unapproved new drug could not. This was a drafting error, but it was nonetheless enforced by FDA. Congress therefore enacted the Drug Export Amendments Act of 1986, which authorised the limited export of unapproved new human drugs and biological products after FDA had approved an export application. An export application could be approved only if... 

The adulteration and misbranding provisions of the statute itself are continually expanded by FDA regulations that impose additional requirements either for all non-prescription drugs or for... 

Hull PB and Hurt PB II. A history of government regulation of adulteration and misbranding 59. of food. Food Drug Cosmetic Law J 1984 39 2. 60. 

---