Trans Fats Are No Longer Generally Recognized As Safe

Trans fat is a popular buzz word in the news and amongst the health conscious. The fatty substance occurs naturally and has been commercially manufactured in our food since the 1940’s. Over the past two decades researchers have reported on its negative health impact.  Many government entities have moved to either ban or restrict its use.  Such political action has occurred here in Cleveland, Ohio, and in other prominent U.S. cities, New York and Baltimore, as well as across the globe in other countries, Canada and Denmark.

A trans fatty acid results from the chemical hydrogenation by which hydrogen atoms are added to carbon-carbon chains to reduce the number of double bonds. The process of saturating the carbon chain alters the configuration from cis to trans. The trans formation adds value to commercially prepared foods by increasing the melting point, shelf life, and flavor stability. In our bodies trans fats increase risks associated with Coronary Heart Disease (CHD). The experts agree that trans fats mediate changes in lipid metabolism, trigger pro-inflammatory effects, and endothelial dysfunction.

In November 2013 the Food and Drug Administration (FDA) announced partially Hydrogenated Oils, which trans fats are the primary dietary source of, are no longer Generally Recognized As Safe (GRAS) for any use in food based on current scientific evidence; although removal of the GRAS status is not final until after the comment period in March 2014.

Generally any substance the intended use of which results in its becoming a component of or otherwise affecting the characteristic of any food is an unsafe “food additive” unless it is used in accordance with 21 U.S.C 321(s) if such substance is not GRAS. A substance is GRAS if it is generally recognized among qualified experts as having adequately shown to be safe under the conditions of its intended use. Moreover, Gras status of a substance used in food is time-dependent.

That time has come for partially hydrogenated oils and trans fatty acids despite being widely used since the 1940’s in margarine, shortening, baked goods, bread, rolls, buns, French dressing, mayonnaise, cookies, frozen pizza, microwave popcorn, frozen pies, etc. Health experts more than generally agree that trans fats are not safe for the health of the public as evidenced by published literature. For examples see studies published by the American Heart Association, the American Dietetic Association, IOM/NAS, FDA Food Advisory Committee Nutrition Subcommittee, the World Health Organization, the CDC, and NHANES to name a few.

Much of the food industry has begun to remove or reduce the level of the substance in their products. If removal of the GRAS status becomes permanent more time and money will be need to completely remove non-naturally occurring trans fats from our food supply.

This action is positive for our health but is only one piece of our lifestyle health dysfunction.

This post is not legal advice-No attorney-client relationship is formed.

Helen Rhynard Esq., M.S., RDN, L.D.

hr@rhynardlaw.com

www.rhynardlaw.com

references: Federal Register/vol. 78, No. 217.

ObamaCare Provides Employer Workplace Wellness Programs with Defenses Against Employee Claims of Discrimination

Wellness programs at work are fast becoming the norm with employers juggling the ever-increasing costs of employee health care.  These are not fluffy, feel good, “get a manicure and a smoothie next Friday” sorts of programs.  The programs are intense demanding results like, “quit smoking or you pay the costs of health insurance”.

Application of heavy-handed strategies to reduce health care costs concerns employers. They risk employee lawsuits alleging discrimination. Lawsuits may be on the horizon but the outcomes may be surprisingly in favor of the employers. Obamacare amended in part the 2006 non-discrimination provisions of The Health Insurance Portability and Accountability Act (HIPAA), thereby providing leverage for employers to impose upon employees the adaptation of healthier lifestyle changes.

In 2006 Congress added §9802 nondiscrimination and wellness provisions (the 2006 Regulations) to HIPAA. These provisions generally prohibit group health plans and health insurance issuers from discriminating against individual participants and beneficiaries in eligibility, benefits, or premiums based on a “Health Factor”; although, allowing an exception for premium discounts, rebates, or modification to cost sharing in exchange for adherence to a health promotion disease prevention program.

The Affordable Care Act of 2010 (ACA) amends HIPAA’s nondiscrimination provisions  Under ACA employers’ group health plans and insurance issuers may discriminate against individuals and beneficiaries based on a “Health Factor” and provide a reward up to 30% of the cost of coverage or as much as 50% of the cost of coverage for a smoking factor. Moreover, compliance with federal regulations is an affirmative defense to a HIPAA discrimination claim.

Health Factor discrimination is defensible because the employees have the option to participate in the wellness program or not. Health Factor rewards are given in return for employee adherence to a wellness program that is reasonably designed to promote health and prevent disease. Wellness programs are divided into two main categories, participatory wellness programs and health contingent wellness programs.  Participatory wellness programs either do not provide a reward or do not include any conditions for obtaining a reward based on satisfaction of a health factor; compared to a health contingent wellness programs which require an individual to satisfy a standard related to a health factor to obtain the award.

A participatory wellness program on its face complies with the HIPAA nondiscrimination provisions without having to satisfy any additional standards if program participation is available to all similarly situated participants regardless of health status. In contrast, a health contingent program must satisfy five statutory requirements to overcome the HIPAA nondiscrimination provisions. ACA mandates…

1. Eligible individuals must have an opportunity to qualify for the reward once per year.

2. The reward must not exceed 30% of the cost of employee only coverage or 50% to the extent the program concerns smoking reduction or prevention.

3. The reward must be available to all similarly situated and provide a reasonable alternative standard or waiver.

4. The program must be reasonably designed to promote health and prevent disease.

5. Plan materials must disclose the terms of the health contingent program.

ACA allows a mechanism to shift the high cost of lifestyle disease from the employer and issuer to the individual forcing individual responsibility.  Wellness programs have been around for nearly 20 years but little comprehensive data exist on program effectiveness. Published literature and the RAND Health Report on Work on Workplace Wellness Programs 2013 corroborate findings on positive effects on health risk and health behavior and suggest a reduction in healthcare costs will materialize with employee participation. This is an opportunity employers may want to take advantage of, but must yield to caution before action. ACA provides an affirmative defense to a HIPAA nondiscrimination claim but that defense may have no effect on other laws, for example ERISA, ADA, and other state or federal laws.

Decisions concerning employee health benefits and workplace wellness programs are difficult. Contact Healthier Futures of Rhynard Law for more information.

This post is not legal advice and does not create an attorney client relationship.

References:

1. Federal Register/vol. 78 No. 106/Monday, June 3, 2013/Rules and regulations.

2. RAND Health, Workplace Wellness Programs Study, Final Report, (2013).

Helen Rhynard Esq., M.S., RDN, L.D.

hr@rhynardlaw.com

www.rhynardlaw.com

Journal of Law and Health Symposium on the Legal and Ethical Implications of Posthumous Reproduction

The United States Supreme Court.

The United States Supreme Court. (Photo credit: Wikipedia)

What: Symposium on the Legal and Ethical Implications of Posthumous Reproduction

Date: Friday, March 22, 2013

Time: 1:00 p.m. – 4:00 p.m.

Background Information: This symposium is presented in response to the recent Supreme Court decision in Astrue v. Capato, 132 S. Ct. 995 (2012). In Astrue, the Supreme Court held that children conceived through in vitro fertilization after the death of a parent were not automatically entitled to survivor benefits under Title II of the Social Security Act.

Speakers:

The event includes 3 free CLE credits. There will be a short reception in the atrium following the event.