Evidence of traditionality of Brazilian medicinal plants: The case studies of Stryphnodendron adstringens (Mart.) Coville (barbatimão) barks and Copaifera spp. (copaíba) oleoresin in wound healing.

ETHNOPHARMACOLOGICAL RELEVANCE: The World Health Organization (WHO) recognizes the potential of plants used in secular traditional medicine and considers this an important source of evidence to assess their effectiveness and safety. Brazil is rich in biodiversity and traditional uses based on the Amerindian culture. However, many processes started with the arrival of the Portuguese in the year 1500. The successive economic cycles, for example, led to destruction of native vegetation and an intense cultural erosion. As a consequence, the information about the use of plants in the past centuries are dispersed and without interpretation. In this study a methodology to evidence the traditionality of Brazilian plants was demonstrated using data about barbatimão barks (Stryphnodendron adstringens (Mart.) Coville - Fabaceae) and Copaiba oleoresin (Copaifera spp. - Fabaceae) in wound healing, was established. MATERIAL AND METHODS: Data about use of the plants were recovered from bibliography published between 1576 and 2011. The books (101) were classified using weights, considering the date of publication and the source of Information. Older books that describe primary information received weight 10, while books written more recently and with secondary information received weight 0.4. A score for each category of medicinal use was calculated based on the books weights and the frequency of citation. A review about the current use of both plants was also performed from ethnobotanical studies published in journals. RESULTS AND DISCUSSION: The traditional secular use of barks of barbatimão and oleoresin of copaiba to treat wounds was confirmed based on the historic bibliographic research. The most frequent use of barbatimão in a timeline of 500 years of Brazil's history, was as astringent, whereas for copaíba was as healing of skin and mucosal lesions. The continuous and current use of these plants to treat wounds, confirmed by recent ethnobotanical studies, is an indicative of the resilience of these remedies and their effectiveness. CONCLUSION: The use of preparations containing barbatimão barks and copaiba oleoresin can be considered effective in the treatment of wounds. Nonetheless, it is necessary to improve the quality of the formulas as established by WHO.

Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment.

We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we received from a manufacturer of OTC astringent drug products. This final rule is part of our ongoing review of OTC drug products.

Skin protectant drug products for over-the-counter human use; astringent drug products; final monograph; direct final rule. Direct final rule.

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. This action revises some labeling for astringent drug products to be consistent with the final rule for OTC skin protectant drug products (68 FR 33362, June 4, 2003) and adds labeling for certain small packages (styptic pencils). This action is part of FDA's ongoing review of OTC drug products. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule.