{BLR 1077} Regulatory - Competitiveness - Association of Biotechnology Companies - Nutritional Products - Health Claims - Food and Drug Administration.

Abstract Coronary heart disease (CHD) is the leading cause of death globally. Consumption of whole grains and cereal fiber, as part of a healthy diet, can lower the risk of CHD. Health claims on food products are effective in helping consumers select healthful diets. The US Food and Drug Administration was the first to approve a health claim, in 1997, between beta-glucan soluble fiber from whole oats, oat bran, and whole oat flour and reduced risk of CHD. Only a few countries have approved similar claims. Since 1997, a significant amount of additional evidence has been published on the relationship between oat beta-glucan and CHD. To assist other jurisdictions in potentially utilizing this claim, the full extent of data that supports this claim (ie, the evidence utilized by the US Food and Drug Administration to substantiate the claim, as well as the results of 49 clinical trials published since 1997) are reviewed here. The complexities involved in authoring evidence-based health claims, including the impact of processing on beta-glucan cholesterol-lowering efficacy in approving eligible beta-glucan products, are also discussed.

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Life after Enron and ImClone: Special concerns for the biotechnology company

Journal of Commercial Biotechnology ◽

10.5912/jcb39 ◽

1969 ◽

Vol 9 (4) ◽

Author(s):

Neil H Aronson

Keyword(s):

Corporate Governance ◽

Drug Administration ◽

Food And Drug Administration ◽

Securities And Exchange Commission ◽

Critical Periods ◽

Private Companies ◽

Public And Private ◽

Biotechnology Companies ◽

Senior Officers ◽

Public Offering

The recent enactment of federal legislation and the ongoing adoption of comprehensive regulations by the Securities and Exchange Commission (SEC) and stock exchanges create a new era for corporate governance. For public biotechnology companies, these new laws and regulations create specific concerns and significant criminal and civil sanctions. Private companies considering a public offering should also consider the implications of these statutes and regulations. In the future, investors are expected to reward both public and private companies that enact strong corporate governance practices.Biotechnology companies will need to carefully review and modify document retention, disclosure, compensation and stock trading policies to comply with the following new requirements:Document retention policies will need to address complex recordkeeping requirements imposed both by the Sarbanesâ€“Oxley Act of 2002 (SOA) as well as a myriad of regulations imposed by the Food and Drug Administration and the Environmental Protection Agency.Severe penalties for improper certification by senior officers of SEC reports places added pressure on public biotechnology companies. Officers will need to establish systems to regularly review the accuracy of disclosures involving all intellectual property, regulatory and healthcare reimbursement disclosures in these periodic reportsCompensation plans for officers and directors must prevent future loans (and modifications to existing loans) and address corporate governance concerns now raised by institutional investors and the media.New reporting requirements for insider sales require that corporations develop systems to accurately track insider sales and to establish systems to prevent insiders and their family members from trading during critical periods preceding Food and Drug Administration and other regulatory actions.

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Health Claims About Cannabidiol Products: A Retrospective Analysis of U.S. Food and Drug Administration Warning Letters from 2015 to 2019

Cannabis and Cannabinoid Research ◽

10.1089/can.2020.0166 ◽

2021 ◽

Author(s):

Kimberly G. Wagoner ◽

Allison J. Lazard ◽

E. Alfonso Romero-Sandoval ◽

Beth A. Reboussin

Keyword(s):

Retrospective Analysis ◽

Drug Administration ◽

Food And Drug Administration ◽

Health Claims

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Can Consumers Interpret Nutrition Information in the Presence of a Health Claim? A Laboratory Investigation

Journal of Public Policy & Marketing ◽

10.1177/074391569601500102 ◽

1996 ◽

Vol 15 (1) ◽

pp. 16-27 ◽

Cited By ~ 104

Author(s):

Gary T. Ford ◽

Manoj Hastak ◽

Anusree Mitra ◽

Debra Jones Ringold

Keyword(s):

Laboratory Experiment ◽

Laboratory Investigation ◽

Drug Administration ◽

Food And Drug Administration ◽

Health Claims ◽

Nutrition Information ◽

Food Label ◽

Health Claim ◽

Consumer Beliefs ◽

Independent Effects

The authors report the results of a laboratory experiment that investigates whether consumers can evaluate nutrition information in the presence of a health claim. Results show that both health claims and nutrition information influence beliefs about product healthfulness. However, health claims do not influence the processing of nutrition information on a food label. Rather, health claims and nutrition information have independent effects on consumer beliefs. The authors discuss the implications of these findings for the Food and Drug Administration policy on limiting health claims.

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Orthodox and Unorthodox Uses of Electronic Cigarettes: A Surveillance of YouTube Video Content

Nicotine & Tobacco Research ◽

10.1093/ntr/nty132 ◽

2018 ◽

Vol 21 (10) ◽

pp. 1378-1384 ◽

Cited By ~ 1

Author(s):

Mignonne C Guy ◽

Jacob Helt ◽

Sherilyn Palafox ◽

Kellie Green ◽

Eric K Soule ◽

...

Keyword(s):

Social Media ◽

Drug Administration ◽

Open Systems ◽

Electronic Cigarettes ◽

Food And Drug Administration ◽

Production Quality ◽

General Information ◽

Health Claims ◽

Health Study ◽

The Us

Abstract Introduction Open electronic cigarette (e-cigarette) systems are customizable by consumers and often allow for potential “unorthodox” use of the product; that is, use not as intended by the manufacturer. Little is known about the types and prevalence of unorthodox uses and how these practices are transmitted via popular social media. Methods Monthly searches of YouTube were conducted from June through November 2016 using the following search terms: “e-cigarettes,” “vaping,” and “e-juice.” After collecting static and dynamic data on the 150 videos identified, two coders independently coded videos for general information, unorthodox use behaviors, health claims, and production quality and characteristics for orthodox and unorthodox use. Intercoder reliability was high (Cohen’s κ 0.81, p < .001). Results One hundred fifty videos were included in the study with a total of 115 551 563 views. We identified nine categories of unorthodox uses of e-cigarettes. Unorthodox use was three times as prevalent as orthodox use. Seventy-seven percent of the unorthodox use videos included recreational e-cigarette use, 57% included modification of mechanical parts and components, and 44.6% included unorthodox substance application (dripping). There were more than twice as many social media links in videos depicting unorthodox compared to orthodox use, but the level of engagement was lower for unorthodox use. Conclusions E-cigarette unorthodox use on YouTube is more prevalent than orthodox use, suggesting the need to further investigate the prevalence of unorthodox use among e-cigarette users and the influence of social media on consumer uptake of unorthodox and orthodox uses of e-cigarettes. Implications The US Food and Drug Administration has regulatory authority over e-cigarettes, parts and components. Many e-cigarettes currently marketed are open systems. Closed systems may allow less manipulation and may influence the safety of these products. This study provides valuable information on ways that open system e-cigarettes are used and it can inform safety tests that can be conducted by the US Food and Drug Administration to determine whether or not these products should remain on the market. In addition, our definitions of unorthodox use can be incorporated into the Population Assessment of Tobacco on Health Study to better understand the prevalence of these behaviors.

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Drugs or Dietary Supplements: FDA's Enforcement of DSHEA

Journal of Public Policy & Marketing ◽

10.1177/074391569801700212 ◽

1998 ◽

Vol 17 (2) ◽

pp. 296-302 ◽

Cited By ~ 15

Author(s):

Marlys J. Mason

Keyword(s):

Dietary Supplements ◽

Dietary Supplement ◽

Drug Administration ◽

Food And Drug Administration ◽

Health Claims ◽

Education Act ◽

Definition Of

The Dietary Supplement Health and Education Act broadened the definition of a dietary supplement and loosened the restrictions for health claims on supplement labeling. The Act has left an unclear boundary between supplements and drugs. In this article, the author examines the legal debate surrounding the definition and regulation of drugs and supplements. The author also discusses recent Food and Drug Administration enforcement activities and court challenges.

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Whole grain health claims in the USA and other efforts to increase whole-grain consumption

Proceedings of The Nutrition Society ◽

10.1079/pns2003242 ◽

2003 ◽

Vol 62 (1) ◽

pp. 151-160 ◽

Cited By ~ 37

Author(s):

Len Marquart ◽

Kathryn L. Wiemer ◽

Julie M. Jones ◽

Brenda Jacob

Keyword(s):

Drug Administration ◽

Food And Drug Administration ◽

Value Added ◽

Health Claims ◽

Nutrition Labeling ◽

Whole Grain ◽

National Academy Of Sciences ◽

Scientific Consensus ◽

Grain Products ◽

Grain Foods

In response to the 1990 Nutrition Labeling and Education Act, the Food and Drug Administration approved seven health claims that addressed the relationship between broad food categories and risk of certain chronic diseases. These claims are based on scientific consensus that includes epidemiological, animal and clinical research. The Food and Drug Administration also established a process to petition for new health claims that address substance-disease relationships supported by adequate scientific and specific regulatory requirements. The whole grain-cancer and heart disease authoritative statement health claim approved in July 1999 followed a completely different process mandated by the Food and Drug Administration Modernization Act of 1997. It is based on an authoritative statement made by a government body that represents scientific consensus and is supported by other scientific agencies and organizations. The scientific basis for the claim published in Diet and Health reflects a comprehensive and deliberative review of epidemiological, animal and human studies by the National Academy of Sciences Committee on Diet and Health. Health claims used on whole-grain products can attract the attention of health-conscious consumers and are important tools in communicating health messages. However, the US public consumes substantially fewer whole-grain servings than recommended by US dietary guidance. Reasons given by consumers for not purchasing whole-grain foods include colour, price, softness, texture, moisture content and taste. Developing tastier value-added whole-grain foods along with simple coordinated messages from industry, the scientific community, public health experts and government will help consumers identify, purchase and consume more whole-grain products.

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