DSHEA PRESENTATION

Timeline

Affected Drugs and Flaws Of The DSHEA

Restrictions, Funtions, And What Led To The Legislation

How Did it all begin?

What Is The DSHEA?

For Todays Lesson

Dietary Supplement Education Act (1994)

By: Elisbeth Nuesi

What Is The DSHEA?

01

The DSHEA stands for Dietary Supplement Health and Education Act. The act gives the FDA the necessary regulatory authority and enforcement resources to protect consumers while maintaining their access to a wide range of reasonably priced, excellent, secure, and helpful dietary supplement products. Dietary supplements come in many different forms such as pills, tablets, capsules, gummies, softgels, liquids, and powders.

What Is The Dshea?

How Did It All Begin?

02

Orrin Hatch was an American attorney as well as a politician. He served as a senator from Utah in the U.S. from 1977 to 2019 he served as a senate for 42 long years this made him the longest republican serving as a U.S. senator in all of history. He created the DSHEA after many efforts and a lot of people having oppositions towards this act in 1994 he succeeded in making the DSHEA legislation that would create a regulatory system for dietary supllements that would guarantee it's consumers safety of use of dietary supplements by this legislation directing and governing them.

who was orrin hatch?

(Dietary Supplement Health and Education Act)

The DSHEA was developed in 1994 but the history for vitamins and how it all started goes back for more than a century. The lack of nutrients in our food isn't a new problem it goes very back so due to this is why our efforts in order to solve this problem goes awhile back towards the 1900s which led to the development of multivitamins. Before supplements were invented of course the discovery to it and its vitamins had to come first. At the beginning of the 20th century there were only 3 nutrients that had been discovered in food which were protein, carbohydrates, and fat. Poor sanitation back then was viewed as the cause to all diseases so foods would be sterilized to get rid of bacteria, mold, and toxins in order to prevent these diseases. What they didn't know back then was that this was actually the cause of it all. Processing grains destroyed essential B vitamins leading to the eras two most common diseases pellagra which was a deficiency of niacin, and beriberi a deficiency of vitamin B1, or thiamine. Sterilizing the milk with heat destroyed vitamin c. Then it was when scientists that were trying to solve this problem discovered that our food actually contains as to more than just 3 nutrients. Casimir Funk is credited for discovering these vitamins and proposed that many diseases could be cured with nutrients. Then, after some time through the 1970s and 1980s it started to be discussed that the selling of these dietary supplements were increasing andthat a regulatory system for it had tobe made in order to guarantee the consumers safety. This is when Orrinn Hatch comes in and creates the DSHEA which would be a legislation that acts as the regulatory system for dietary supplements. The DSHEA is subject to the FDA for good manufacturing practices. Not only did this legislation guarantee consumers safety but it also helped the dietary supplements that had no legal protection gain clarification, supplements such as botanicals, amino acids, and fish oils.

The History Of DSHEA

Restrictions, Funtions, And What Led To The Legislation

03

What Led To The DSHEA Legislation

Before the DSHEA ws created the regulation of dietary supplements was debated for decades or " foods for special dietary uses which was as they were known back then this started as early in the 1930's. The first regulatory was made in 1938 called The Food and Drug Cosmetic Act. This was made to provide better food safety. In 1968 regulations were made regarding health risk issues, which was why due to this during the 1970s and 1980s discussions started to be made around creating a regulatory system for dietary supplements to ensure consumers wouldnt fall of the rails with these supplements. The DSHEA was created with two main goals to maintain consumers' access to a wide range of dietary supplements and to give them additional knowledge about how to use dietary supplements.

Restrictions

• Any dietary supplements that are misbranded or in which it's marketing is adulterated will be banned for its producers and distributors.
• The DSHEA was written to limit the FDA's oversight of dietary products
• Before deciding to buy a dietary supplement it is advised by the FDA to talk to a doctor, pharmacist, or another healthcare provider
• The FDA is not allowed to approve any dietary supplements before they are marketed.

Restrictions and what led to the dshea legislation

Functions: The FDA has the authority to regulate dietary supplements. The FDA is in charge of laws and regulates regarding dietary supplements. The agency carries out inspections, keeps an eye on the market, looks at dietary supplements and dietary ingredients that are offered for import, and studies NDI notifications and other regulatory submissions for dietary supplements in order to spot irregularities. Additionally look into consumer, healthcare provider, industry, and other regulatory authorities' reports of adverse events.

functions of the fda with the dshea

Affected Drugs and Flaws Of The DSHEA

04

• The DSHEA was made to ensure that dietary supplements are regulated to ensure that they are safe, effective, and truthfully advertised. Although this is very far from the truth since the FDA is very limited when it comes to regulating the DSHEA.
• The dietary supplements that are being selled have a lot of misinformation that is being given to future buyers.
• The DSHEA increased the amount of products that can be sold as "supplements" many products mostly herbs are being marketed for their therapeutic effects but ever since 1994 when the DHEA law was made it's been almost impossible for the FDA to regulate these herbs as drugs.
• The FDA cannot ban questionable supplement ingredients as "unapproved food additives," as per the DSHEA.
• The FDA can't assure that the products that are being said to be in these dietary supplements are actually in them.

• The FDA isn't able to monitor and regulate thousands of dietary supplements products due to this the buyers are being unprotected against supplements and herbs that are unsafe.

Flaws That haven't Changed

The DSHEA was created to grant consumers a wide variety of access to dietary supplements while still guaranteeing their safety through the FDA. Dietary supplements are classified with food they are not classified as drugs. This means that these supplements shouldn't contain any amount of drug within them but it turns out they do. Although regulated by the FDA these supplements containing drugs which they aren't supposed to haven't been recalled by the FDA in order to be removed from the market, they just keep selling. In fact, the most affected drugs by this due to being the most found within the supplements were Sildenafil which is an active ingredient in Viagra this was used for sex supplements, Sibutramine being a banned weight loss drug was still being used for weight, and Synthetic Steroids used for muscle building.

Drugs Affected by the dshea

timeline

05

In 1997 a rule was made in which effects that were caused by these dietary supplemets wouldn't be told until their was a protest of 100,000 messages by the supplement industry in January 6, 2000 so the FDA made a final rule on he health claims for dietary supplements. DSHEA permits claims now that products affect the structure or function of the body

Microbial contamination was found in dietary supplments.Dietary supplements need to be grown and arvested and in these steps microbial contamination can result. 37 different products were found to have one or more different types of Salmonella. fifty hospitalizations, and 199 adverse events between January 2017 and may 2018. 3 Salmonella infections have caused the recall of countless additional dietary supplement products just in 2018 alone.

Lorem ipsum

2017

The FDA must be notified of any major adverse events involving dietary supplement and nonprescription drug manufacturers' products under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546), which was passed in December 2006. Manufacturers must begin disclosing fatalities, life-threatening incidents, inpatient hospitalizations, permanent or major disability or incapacity, birth deformities, or the requirement for medical intervention to stop any such issues as of December 2007. In order for customers to contact manufacturers, manufacturers must also include a phone number or address on product labels.

Lorem ipsum

2006-2007

A survey was conducted in which it was found that 75% of respondants wanted the government to review the safety and approve dietary supplements before selling them.

ipsum

2001

1997-2000

The DSHEA was enacted in 1994 with the help of Orrin Hatch. had two main objectives: to maintain consumer access to a broad range of dietary supplements and to give consumers more knowledge about the intended use of dietary supplements.

Beginning

1994

DSHEA Timeline

Any questions?

https://www.fda.gov/food/dietary-supplements https://www.chpa.org/news/2021/10/look-back-dshea-27-years-later https://journals.sagepub.com/doi/full/10.1177/1060028019900504 https://quackwatch.org/consumer-protection/dshea/ https://pubmed.ncbi.nlm.nih.gov/20837113/

+ INFO

Write a subtitle here

Sources