A white paper: US biosimilars market on pace with Europe

In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed.

Vape Shop Owners/Managers’ Opinions About FDA Regulation of E-Cigarettes

Introduction In the United States, prominent sources of vaping products are specialty vape shops, which are subject to Food and Drug Administration (FDA) regulation. This study interviewed vape shop owners/managers to assess: (1) reasons for entering into or engaging in vape shop retail; (2) personnel training, particularly with regard to FDA and state regulations; and (3) how existing regulations are perceived and the anticipated impact of future regulation. Aims and Methods The current study involved phone–based semi-structured interviews of 45 vape shop owners/managers in six metropolitan statistical areas (Atlanta, Boston, Minneapolis, Oklahoma City, San Diego, and Seattle) during Summer 2018 as FDA regulations regarding minimum age verification, bans on product sampling, and health warnings (among others) were first being implemented. Results Vape shop owners/managers reported: (1) entering the industry with positive intentions for their customers, (2) training their personnel to adhere to regulations and provide good customer service, and (3) significant concerns about the impact of FDA regulations. With regard to the latter, participants reported mistrust of the intentions of the FDA regulations, financial implications of the regulations (particularly for small businesses), difficulty understanding and interpreting the regulations, insufficient evidence to support the regulations, negative impact on customer service, negative impact on product offerings and product innovation/advancement, and negative implications of flavor bans and/or restrictions on sale of flavors. Conclusions These findings indicate the complexities in implementing tobacco regulations, particularly from the perspective of the vape shop industry. Current findings should inform future regulatory actions and efforts to assess compliance with regulations. Implications Current and impending FDA regulation of vaping products present a critical period for examining regulatory impact on the vape shop industry. Current results indicated that many vape shop owners/managers reporting positive intentions for engaging in the vaping product industry and in training vape shop personnel to adhere to regulations. However, the majority reported concerns about FDA regulation and other state/local regulations that could have negative implications for their industry. Particular concerns include difficulty understanding the regulations due to complexity, vagueness, and changes in language and/or interpretation over time. These issues have implications for compliance that must be addressed.

Children’s Fruit “Juice” Drinks and FDA Regulations: Opportunities to Increase Transparency and Support Public Health

Objectives. To compare children’s drink products that contain or purport to contain juice and evaluate labels in light of US Food and Drug Administration (FDA) regulations. Methods. In 2019, we analyzed federal law for drinks that contain or purport to contain juice by using LexisNexis and FDA’s Web site, identified top-selling children’s “juice” drinks in fruit punch flavors, gathered labels in store and online, and extracted data from the principal display and information panels. Results. FDA regulations permit a wide range of names, claims, and fruit vignettes on drinks that contain or purport to contain juice, reflecting the product’s flavor and not necessarily its ingredients. We identified 39 brands of children’s drinks, including 100% juice (n = 7), diluted juices (n = 11), juice drinks (n = 8), fruit-flavored drinks (n = 8), and flavored waters (n = 5), with nonuniform statements of identity; vitamin C and low-sugar claims; and fruit vignettes representing 19 fruits. Many products contained added sugar and nonnutritive sweeteners but little to no juice. Conclusions. Principal display panels rendered it difficult to differentiate among product types, identify those with added sweeteners, and distinguish healthier products. Revised labeling regulations are warranted to support public health.

Regenerative Medicine: Analysis, Forecast and Regulatory Requirements

Regenerative medicine is a new and expanding field in biomedical research. Organ and tissue loss through disease and injury, propel the development of a treatment that can regenerate tissue and help for less relaying in organ transplantation. Regenerative medicine has the potential to heal tissue and damaged organ. Currently, a patient suffering from diseased and injured organs can be treated with transplantation organs, but there is a shortage of donor organs. Dermatology is estimated to have a larger share in the market for regenerative medicine as skin being an organ with great cell replicate characteristics. US and Japan play a major role in the market for regenerative medicine. Food and drug administration (FDA) regulations for a medical device used in regenerative medicine are covered here to support risk-based, flexible regulatory methods to help and support the potential to bring novel treatment possibilities to market further. But due to incorrect FDA regulations, it stands as a barrier for the marketing regenerative medicines. Better and clear guidance development or a clear regulatory framework for both regenerative medicine and medical device can leads the product a best fit clinical development and product access in the market.

Unbinding Regulations

The steady growth in imposed regulations, often defended on the basis of the precautionary principle (which forbids innovations until there is proof that they will cause no harm), increases the risks and costs of innovation for the entrepreneur. Many important innovations of the last century would not have occurred if the precautionary principle had been in operation. Organic regulation of the marketplace (including tort actions and private ratings firms) can counter injuries due to irresponsible firm behavior, without stifling innovation. OSHA regulations did not reduce workplace deaths; financial regulations did not stop the Crisis of 2008, and may have made it worse. Occupational licensing regulations protect incumbents, and reduce opportunity for the least well-off. By slowing new life-saving drugs, FDA regulations cause more deaths than they prevent. The Vodnoy paradox suggests that we favor regulations in areas where we are ignorant and oppose them in areas where we are knowledgeable.

Facility Registration and Initial Regulatory Compliance Activities for Acidified Food and Low-Acid Canned Food Processors in Florida

Food businesses are subject to a wide range of regulatory requirements. Food entrepreneurs who want to produce and sell acidified foods or low-acid canned foods must abide by specific FDA regulations. This new 3-page document intends to clarify the initial steps food entrepreneurs must implement to comply with these regulations. This factsheet is one in a Food Entrepreneurship in Florida series, which assists beginning and established food entrepreneurs by providing them information on topics highly relevant to starting and running a food business: regulations, safety, labeling, processing, and marketing. Written by Matthew Krug and Soohyoun Ahn, and published by the UF/IFAS Food Science and Human Nutrition Department, February 2019. http://edis.ifas.ufl.edu/fs318