Missing the Mark: FDA Regulations

Veronica Haywood, New Leaders Council San Antonio

For years pediatricians have been encouraging families to introducing solid foods to their babies around six months of age, but what they failed to mention is that one the most recommended beginner foods suggested, infant rice cereal, has relatively high level of arsenic.

The new study from Healthy Babies Bright Future found that infant rice cereal is six times higher than any other non rice cereal or multi-grain cereals[1]. Consuming arsenic in infant rice cereals has been linked to cause cancers and permanently reduces children’s learning ability. Although there is no evidence on any safe level of consumed arsenic, the U.S. Food and Drug Administration (FDA) has failed to change manufacturing guidance and has failed our infants.

This is surprising since the Environmental Public Agency strictly regulates arsenic in drinking water, but it can legally be in any amount in infant rice cereal[2]. Unfortunately the FDA has dropped the ball in mandating stricter food manufacturing standards and a couple weeks ago decided it would not renew the charter of its Food Advisory Committee.

This group was established in 1992 to oversee matters of food science, food safety and nutrition. The committee “has held only a handful of meetings over the past several years and has not met since 2015. Therefore, FDA has determined that the effort and expense of maintaining the advisory committee is no longer justified,” the agency said[3]. The agency states it will use other standing committees and individual consult experts.

Recently the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) provided insight into current regulations under review and development for 2018 through its semiannual compilation of information[4].

FDA’s contributions to the Fall 2017 Unified Agenda put priority on addressing:

Nicotine Addiction Crisis

FDA is making efforts to reduce the morbidity and mortality associated with tobacco with a comprehensive approach to nicotine and the regulation of combustible cigarettes. Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. An Advance Notice of Proposed Rulemaking is asking critical questions related to regulation that would result in a targeted reduction of the nicotine levels in combustible cigarettes to eliminate or dramatically reduce their addictive value. It also will look to regulate flavors in tobacco products to limit their appeal to youth, while considering the potential role that some flavors may play in helping users transition away from combustible products.

Advance Drug Safety

FDA will work to issue several regulations on drug compounding to help ensure the quality of medicines that patients need. Ensuring that outsourcing to facilities has clear understanding to which drugs they may compound and allow these firms to adopt more efficient, streamlined manufacturing standards, while ensuring they observe necessary safety and quality measures.

Promoting Food Safety

To address critical issues related to the overall safety of the food we eat, FDA intends to propose a rule on lab accreditation, which would establish a program to accredit labs to do food safety testing and to require that these accredited labs be used in certain situations.

Empowering Consumers

The FDA is also empowering consumers to be more informed about products they consume with better understanding and access to nonprescription drugs. This will allow some drugs that would otherwise require a prescription to be marketed without a prescription through the use of innovative technologies and other conditions that will ensure appropriate self-selection and appropriate actual use of the nonprescription drug product by consumers.

Modernizing standards

With the modernization of standards there will be more clearly defined standards to help promote the the protection of consumers and patients. One of the proposed changes includes to modernize mammography quality standards that will improve women’s health. The aim is to recognize advances in technology and help to ensure women get the most relevant, up-to-date information about their breast density, which is now recognized as a risk factor for breast cancer.[5]

Many patients and consumers rely on regulation approvals to ensure safe delivery of advanced innovations and therapies. The FDA must continually adapt our regulations to enhance efficiency, improve our effectiveness, and update old and out-of-date requirements for the protection of our future generations. Although doing away with the food advisory committee charged with providing input on important matters involving food science, food safety and nutrition may not be the most efficient way to move forward on some of these goals, there is still hope that necessary improvements are made to the U.S. Food and Drug Administration.

Veronica writes a column for The New Leader entitled Keeping Her Safe. Check out all of her articles here.

Veronica Haywood is a registered nurse,lactation consultant, women’s health nurse practitioner student, and co-founder of her nonprofit Latched Support. She is also a member of the New Leaders Council-San Antonio Executive Board, a 2017 NLC San Antonio fellow, and a NLC Life Entrepreneurship trainer. She can be reached at veronicahaywood@gmail.com.

[1]http://www.healthybabycereals.org/sites/default/files/2017-12/HBBF_ArsenicInInfantCerealReport.pdf

[2] https://www.epa.gov/dwreginfo/chemical-contaminant-rules

[3] https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm588565.htm

[4] www.gsa.gov/unifiedagenda.

[5]https://blogs.fda.gov/fdavoice/index.php/2017/12/looking-ahead-some-of-fdas-major-policy-goals-for-2018/