The FDA Should Not Further Regulate the Use of Vitamins, Nutritional Supplements, Probiotics, Traditional Chinese Medicine, Herbal Products and Homeopathy.

WHEREAS, THE FDA CURRENTLY HAS THE LEGAL, REGULATORY AUTHORITY TO REMOVE DIETARY SUPPLEMENTS

The first point of debate is that the FDA already has the authority to regulate and remove products from the market.  Whereas, the National Institutes of Health, Office of Dietary Supplements states that dietary supplements currently are regulated by the Food and Drug Administration.  Specifically, dietary supplements are in a separate category, classified as a dietary supplement, a conventional food or a drug, based upon its intended use.  Congress defined what a dietary supplement is in the Dietary Supplement Health and Education Act (1994).  “A dietary supplement is a product (other than tobacco) that:

•  is intended to supplement the diet;

•  contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;

•  is  to be taken by mouth as a pill, capsule, tablet, or liquid; and

•  is labeled on the front panel as being a dietary supplement.” (National Institutes of Health, Office of Dietary Supplements)

This isn’t the first time that this debate has occurred.  In 1994, the FDA wished to regulate the Dietary Supplement industry.  To address the FDA’s concerns, congress passed a bill called the: Dietary Supplement Health and Education Act of 1994.  This Act provides, “The primary framework for the regulation of dietary supplements is the Dietary Supplement Health and Education Act of 1994 (“DSHEA”).  Underlying DSHEA is the congressional intent to support two goals: “(1) to facilitate consumer access to dietary supplements, given that many dietary supplements are used by consumers to help them maintain and improve their health; and (2) to give the Food and Drug Administration (“FDA”) the authority to step in where safety problems arise and to ensure proper labeling.” (What Lies Beneath, Ziker)

Furthermore, the public is further protected when a Dietary Supplement manufacturer wishes to introduce a new dietary ingredient (an ingredient that was not sold in the United States in a dietary supplement before October 15, 1994), specific safety information from the manufacturer is required.

Labels of a dietary supplement product are required to be truthful and not misleading.  If the label does not meet this requirement, the FDA already has the authority to remove the product from the market place or take other appropriate actions.  This bears repeating.  The FDA already has the authority to remove a product from the market place when it is misleading or not truthful.

Label claims on dietary supplements are regulated and may not claim that the product will: “diagnose, cure, mitigate, treat or prevent a disease.” (National Institutes of Health, Office of Dietary Supplements)   What dietary supplements are allowed to make one of three types of claims: “a health claim, nutrient content claim or a structure/function claim.  Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it cannot mention any specific disease.” (National Institutes of Health, Office of Dietary Supplements)

One can only determine from this information that there is another reason for the FDA or a Dietary Supplement manufacturer wishing for more regulatory control over the Dietary Supplement industry.  If they already have the authority to remove products from the market, one has to reasonably conclude two possible scenarios as to their purpose:  that they wish to broaden the Dietary Supplement classification method to state that a product will diagnose, cure, mitigate, treat or prevent a disease.  We already have a classification which manages these claims; therefore, additional regulations are redundant and superfluous.  The other possible reason for the FDA or a Dietary Supplement manufacturer to desire more regulatory control is that they wish to force a new supplement to require that they be classified as a drug verses as a Dietary Supplement.  This can have only two purposes: eliminate the competition or to increase the FDA’s user fees, paid by drug and medical device companies since the Food and Drug Administration Modernization Act of 1997 (FDAMA).  What we need to keep in mind is that if the FDA has determined that a Dietary Supplement is not safe, is not truthful about their claims or has been misleading, it currently has the authority to eliminate that product from the market or “take other appropriate actions”.

WHEREAS, THE FDA’S OBJECTIVITY AND, AS A RESULT, THEIR ASSURANCE OF SAFETY HAS BEEN COMPROMISED

In 1997, congress passed the Food and Drug Administration Modernization Act of 1997.  This Act, in part, wanted to offset the financial and economic burden of the FDA’s evaluation of all Drugs, Food and Dietary Supplements by accepting “User Fees” from the very manufacturers of these drugs, foods and dietary supplements.  While the FDA’s evaluation processes have been affected by financial gain due to lobbyists lobbying Congress to steer laws and regulations, this new Act essentially cut out the middle-man (lobbyist) and started paying for results.  While I cannot scientifically prove this link between user fees and FDA approval, it is evident that the FDA’s ability to evaluate and render substances safe has been significantly compromised.  Since this Act has taken effect, recalls from previously approved medical devices and drugs are on the rise.  In addition to the changes in this Act, the FDA has been significantly compromised by leadership in the FDA not recusing themselves when reviewing studies where their objectivity had been compromised.  Much of the FDA’s leadership has previously been employed by companies with studies facing FDA reviews.  For example, Monsanto sought approval for a genetically engineered cattle drug rBGH which had failed to gain approval in Europe or Canada, despite lobbying efforts and of malpractice:

“Michael R. Taylor, the FDA’s deputy commissioner for policy, wrote the FDA’s rBGH labelling guidelines. The guidelines, announced in February 1994, virtually prohibited dairy corporations from making any real distinction between products produced with and without rBGH. To keep rBGH-milk from being “stigmatized” in the marketplace, the FDA announced that labels on non-rBGH products must state that there is no difference between rBGH and the naturally occurring hormone.  In March 1994, Taylor was publicly exposed as a former lawyer for the Monsanto Corporation for seven years. While working for Monsanto, Taylor had prepared a memo for the company as to whether or not it would be constitutional for states to erect labeling laws concerning rBGH dairy products. In other words Taylor helped Monsanto figure out whether or not the corporation could sue states or companies that wanted to tell the public that their products were free of Monsanto’s drug. Taylor wasn’t the only FDA official involved in rBGI-1 policy who had worked for Monsanto. Margaret Miller, deputy director of the FDA’s Office of New Animal Drugs was a former Monsanto research scientist who had worked on Monsanto’s rBGH safety studies up until 1989. Suzanne Sechen was a primary reviewer for rBGH in the Office of New Animal Drugs between 1988 and 1990. Before coming to the FDA, she had done research for several Monsanto-funded rBGH studies as a graduate student at Cornell University. Her professor was one of Monsanto’s university consultants and a known rBGH promoter.  Remarkably, the GAO determined in a 1994 investigation that these officials’ former association with the Monsanto corporation did not pose a conflict of interest. But for those concerned about the health and environmental hazards of genetic engineering, the revolving door between the biotechnology industry and federal regulating agencies is a serious cause for concern.”  ISOOS

Monsanto US Government

Furthermore, “Sure enough, in April 2011, the FDA moved to allow Monsanto to perform their own environmental impact study on the very GMOs it has been responsible for developing.

In that same month, the leading scientific journal Science Direct published a study showing a significant conflict of interest in so-called “research” done on the health risks and nutritional assessment of genetically modified products. Speaking of conflict of interest…

•  Michael Taylor, former Monsanto Vice President, is the FDA Deputy Commissioner for Foods.
•  Roger Beachy, former director of the Monsanto-funded Danforth Plant Science Center, is the director of the USDA National Institute of Food and Agriculture.
•  Islam Siddiqui, Vice President of the Monsanto and Dupont-funded pesticide-promoting lobbying group, CropLife, is the Agriculture Negotiator for the US Trade Representative.
•  Rajiv Shah, former agricultural-development director for the pro-biotech Gates Foundation (a Monsanto partner and stockholder), served as Obama’s USDA Under-Secretary for Research Education and Economics and is currently the head of USAID.
•  Elena Kagan, who took Monsanto’s side against organic farmers in the Roundup Ready alfalfa case, is an Associate Justice of the Supreme Court.
•  Ramona Romero, former corporate counsel to DuPont, is the General Legal Counsel of the United States Department of Agriculture.”

There is significant evidence on this front.  In fact, it is endless.  It isn’t political party specific.  It is government specific.  Governmental safeguards which were originally set up to protect the public are no longer protecting us.  Adding to the FDA’s responsibilities to regulate the Dietary Supplements industry further is not in the public’s best interest, or interest, and could cause harm.

Works Cited:

Dietary Supplements, Authors: National Institutes of Health, Office of Dietary Supplements, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/

FDA Fails to Protect Americans from Dangerous Drugs and Unsafe Foods, Authors: Jeff Cronin, Ariana Stone, Center for Science in the Public Interest, Michael Jacobson, Ph.D.

Supplement Regulation: Be Careful What You Wish For, Scott Gavura on August 5, 2010, https://sciencebasedmedicine.org/supplement-regulation-be-careful-what-you-wish-for/

Failures of the FDA to Follow Through Since the Food and Drug Administration Modernization Act (FDAMA) of 1997, Professional Compounding Centers of America, July, 2013, http://www.protectmycompounds.com/wp-content/uploads/2013/06/Inaction-of-the-FDA-since-FDAMA-of-1997-6-21-13.pdf

Investigation Exposes ‘Potentially Fatal’ FDA Failures, Wins National Award, Author: Kathryn Watson, 4/25/2016, http://dailycaller.com/2016/04/25/investigation-exposes-potentially-fatal-fda-failures-wins-national-award/#ixzz4dxrTSWEf

The Regulation of Dietary Supplements in Canada: Many Promises but Little Progress. Authors: Temple, Norman J., Centre for Science, Athabasca University, Athabasca, Alberta, Canada, Journal of Dietary Supplements. 2017, Vol. 14 Issue 1, p117-120. 4p., http://search.ebscohost.com.ccco.idm.oclc.org/login.aspx?direct=true&db=a9h&AN=119093028&site=ehost-live

The FDA, Congress, And Mobile Health Apps: Lessons From DSHEA and the Regulation of Dietary Supplements, Author: Bilbrough, Natalie R., University of Maryland Francis King Carey School of Law, Maryland Law Review. 2015, Vol. 74 Issue 4, p921-968. 48p., http://web.b.ebscohost.com.ccco.idm.oclc.org/ehost/pdfviewer/pdfviewer?sid=2fb47cdc-c7ec-47e6-926e-d79c2e97ec09%40sessionmgr101&vid=2&hid=101

Dietary Supplement Regulation: A Comparative Study, Author: Mason, Sara Atherton, Florida State University College of Law, Source: Journal of Transnational Law & Policy. 2010, Vol. 20, p103-127. 25p., http://web.b.ebscohost.com.ccco.idm.oclc.org/ehost/pdfviewer/pdfviewer?sid=3c527a36-b011-4730-8377-d3fea747fd93%40sessionmgr120&vid=1&hid=101

What Lies Beneath: An Examination of the Underpinnings of Dietary Supplement Safety Regulation, Authors:Ziker, Dana, Source: American Journal of Law & Medicine. 2005, Vol. 31 Issue 2/3, p269-284. 16p., http://web.b.ebscohost.com.ccco.idm.oclc.org/ehost/pdfviewer/pdfviewer?sid=8f03ba5b-d4cf-4560-bd5c-58c1a2889176%40sessionmgr103&vid=2&hid=101

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Recalls/default.htm

https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm

https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm

https://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/default.htm

https://www.fda.gov/Cosmetics/ComplianceEnforcement/RecallsAlerts/default.htm

USDA moves to let Monsanto perform its own environmental impact studies on GMOs, Author: Tom Philpott, Grist, April, 2011, http://grist.org/industrial-agriculture/2011-04-19-usda-to-let-monsanto-do-own-environmental-impact-studies-on-gmos/

FDA Approves POSILAC® Production at Monsanto’s Augusta Facility, Monday March 20, 2006, http://news.monsanto.com/press-release/fda-approves-posilac-production-monsantos-augusta-facility

 

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