[Congressional Record Volume 162, Number 93 (Monday, June 13, 2016)]
[Extensions of Remarks]
[Pages E889-E890]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]





     PUERTO RICO OVERSIGHT, MANAGEMENT, AND ECONOMIC STABILITY ACT

                                 ______
                                 

                               speech of

                            HON. MATT SALMON

                               of arizona

                    in the house of representatives

                         Thursday, June 9, 2016

       The House in Committee of the Whole House on the state of 
     the Union had under consideration the bill (H.R. 5278) to 
     establish an Oversight Board to assist the Government of 
     Puerto Rico, including instrumentalities, in managing its 
     public finances, and for other purposes:

  Mr. SALMON. Mr. Chair, I rise today to speak to an action taken by 
the Puerto Rican Secretary of Health who issued Administrative Order 
No. 346 on February 9, 2016. This Order is noteworthy in that it was 
issued without the benefit of review by Puerto Rico's legislature, and 
without any prior notice or comment period afforded to impacted parties 
that typically accompanies the publication of such Orders.
  Order No. 346 imposes an unprecedented set of regulatory requirements 
and fees on the nutritional dietary supplement industry that will 
invariably increase the cost to consumers who rely upon nutritional 
supplements as an adjunct to their normal diet.
  This Order creates significant economic barriers to acquiring 
nutritional supplements that have been widely accepted by consumers as 
a way of maintaining healthy lifestyles and preventing adverse health 
events in their lives.
  The Congress has recognized the importance of encouraging American 
adults to maintain minimum average daily intake of a variety of 
nutrients that are essential to maintaining health and well-being. The 
U.S. government has encouraged and funded a broad range of consumer 
education initiatives across the spectrum of public health agencies in 
the federal government with the goal of providing consumers with 
valuable information about the importance of the minimum daily 
nutritional intake standards required to maintain good health.
  Nutrition experts at the Harvard School of Public Health have 
emphasized the importance of a food pyramid that recommends a ``daily 
multivitamin plus extra vitamin D (for most people).''
  Researchers at Tufts University have designed a specific food guide 
for the elderly that features the benefits of daily supplements of 
calcium, vitamin D, and vitamin B-12 that are needed for optimal 
health.
  The American Academy of Nutrition and Dietetics has issued a policy 
statement that emphasizes the importance of good food choices, and it 
also recognizes that nutritional supplements can help some people meet 
their daily nutritional needs.
  Supplements should be seen as one component of the search for a 
healthier lifestyle, including improvements in overall food habits and 
engaging in physical exercise. Much of the current research on 
nutrition and health focuses on prevention of chronic disease, but the 
primary reason most people use multivitamins and other nutritional 
supplements is to support overall wellness.
  I was astounding to me to find out about Order No. 346 issued by the 
Puerto Rican Secretary of Health that imposes a set of onerous market 
access fees in Puerto Rico for nutritional supplements, including a $25 
fee on retailers and distributors for every variation of the supplement 
by size, flavor, and stock keeping unit (``SKU'').
  But the ``money grab'' did not stop there.
  Manufacturers must file an application and pay an additional $500 fee 
every 2 years for products that they intend to sell in Puerto Rico.
  Wholesale and Retail distributors must also register and pay an 
additional $100 fee every 2 years.
  Facilities are subject to inspection, and must pay a $50 fee every 2 
years.
  In addition, Order No. 346 also imposes an additional significant 
administrative burden by requiring quality control data, Certificates 
of Analysis, the process used to obtain the product, label samples, 
promotional materials, Advertisements, Laboratory Certificates, and any 
and all warning statements which the FDA does not require of retailers 
of any regulated goods, which includes foods, drugs, and devices.
  These requirements are transparently only justifications for the 
imposition of this new regimen of fees.
  This onerous new fee structure may have the unintended consequence of 
usurping the role of the FDA in regulating the introduction of 
nutritional supplements into commerce as this Congress has determined 
by statute to be sufficient.
  There has not been any significant incident in Puerto Rico where a 
nutritional supplement manufacturer has introduced a tainted product to 
consumers. Nor is there any record of any significant number of adverse 
events attributable to the sale of nutritional supplements to Puerto 
Rican consumers. Furthermore, there are no reports of abusive 
commercial activities by nutritional supplement retailers in Puerto 
Rico.
  Finally, there are no unique public health concerns or issues 
attributable to nutritional supplement manufacturing or sales to 
consumers in Puerto Rico that have not been fully and adequately 
addressed by the FDA.
  Federal public health agencies, research organizations, and non-
government organizations widely encourage the use of nutritional 
supplements to maintain minimum dietary intake, particularly for at-
risk populations like the elderly and low-income families.
  Intuitively, one would think that the Public Health Agency 
responsible for the promotion of health and well-being of the people of 
Puerto Rico would be tearing down any barrier that exists for its 
people to access nutritional foods and supplements that promote the 
health and well-being of families.
  But the reality is, and it is a conundrum that is well known to this 
body, is that Puerto Rico is in the midst of a serious financial crisis 
for which it is seeking relief.
  As I understand it, Order No. 346 is a transparent and perverse way 
for the Puerto Rican government to generate revenue. I cannot help but 
remember the lyrics of a favorite song of mine sung by country music 
star Waylon Jennings, ``Looking for Love in All the Wrong Places.''
  Is it not wrong to be looking for new revenue by increasing the costs 
to Puerto Rican families for nutritional supplements that assist them 
in maintaining a healthy lifestyle and thereby help them avoid adverse 
and costly health events that would incur potentially avoidable costs 
both to patients and government health care programs?
  Is it not wrong for the Secretary of Health to impose a back-door tax 
on nutritional supplements without the benefit of a statute authorizing 
these fees enacted by the Puerto Rican legislature?
  Is it not wrong to single out one industry, particularly an industry 
whose products support a public policy to promote the health and well-
being of its citizens--particularly the elderly and children?
  How can the Puerto Rican government come to this Congress and expect 
to be taken seriously in their request for fiscal relief from their 
current debt burden when they are continuing to enact policies like 
Order No. 346 that are so grossly counterintuitive to good government 
policy?
  My colleague, Mr. Zinke, has authored a legislative remedy that will 
nullify Puerto Rico Administrative Order No. 346.
  I fully support this legislative effort that will protect the people 
of Puerto Rico from arbitrary and onerous restrictions on their access 
to nutritional supplement products, and threatens to damage the 
economic growth of the economy in Puerto Rico.
  If Administrative Order No. 346 is allowed to stand, the cumulative 
effect of a new layer of bureaucratic ``red tape'' and the unjustified 
imposition of regulatory fees will make Puerto Rico the costliest place 
to do business by natural products retailers anywhere in the United 
States or its territories.
  Low income consumers will likely be forced away from legitimate 
retailers on the Island and seek access to reasonably priced products 
on the Internet. The problem with that strategy is that the Internet is 
well known as a haven for counterfeit products and fly-by-night 
suppliers who regularly avoid the scrutiny of the FDA and failed to 
maintain good manufacturing practices for the production of its 
products.
  The perverse outcome of Administrative Order No. 346 is that it will 
actually increase the threat to public health among the citizens of 
Puerto Rico.
  An equally perverse outcome of Administrative Order No. 346 is that 
many Puerto Rican families will be unable to afford the increase in 
prices on nutritional supplements that they rely

[[Page E890]]

upon, and they will likely forgo those expenditures. Low income 
families will be hit the hardest as they are less likely to get 
nutrition they need from food alone, and nutritional supplements our 
key part of their maintaining the health and well-being.
  And I would ask my colleagues to consider this: Administrative Order 
No. 346, if it is allowed to stand, sets a dangerous precedent for 
every legitimate business operating in Puerto Rico today. If the 
Congress fails to nullify this order, nothing will stand in the way of 
the Government of Puerto Rico from imposing similar regulatory regimens 
on every other industry on the Island, without any notice or debate, 
and it will become the incubator for this terrible policy to migrate to 
other states and territories who are looking to enhance revenues.
  Much of what we do here in the Congress is to establish public 
policies to protect consumers from exploitive and predatory actions of 
unscrupulous manufacturers of products that economically harm our 
citizens.
  We are confronted today by a desperate Puerto Rican Government who 
appears to have set aside its duty to responsibly enact public policies 
that are consistent with the regular order of commerce, particularly as 
it relates to nutritional supplements, and has embarked on a clearly 
exploitive and predatory path to fleece nutritional supplement 
manufacturers and penalize its own consumers in the process.
  The Congress is now required to act to defend its own authority and 
regulatory framework for nutritional supplement products as 
administered by the FDA, the Federal Trade Commission, and the 
Department of Justice. We must act in order to prevent this exploitive 
and predatory action by the Puerto Rican Government that will have the 
inevitable consequence of harming its own citizens.

                          ____________________