1) The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines and regulates dietary supplements in the US, placing them in the food category and requiring manufacturers to ensure safety and accurate labeling. 2) Use of dietary supplements increased after DSHEA, with over half of US adults regularly using supplements by 2003-2006, especially women. 3) DSHEA aimed to ensure continued consumer access to supplements while providing more information, without changing their status as foods regulated by FDA for safety.

1. DIETARY SUPPLEMENT HEALTH &
EDUCATION ACT OF 1994

2. DSHEA
The Dietary Supplement Health and Education Act of 1994
("DSHEA"), is a 1994 statute of United States Federal legislation
which defines and regulates dietary supplements. Under the act,
supplements are effectively regulated by the FDA for Good
Manufacturing Practices under 21 CFR Part 111.

3. WHY SUPPLEMENTS AS FOOD
• Food is the primary source of nutrients to keep us nourished and
healthy.
• Poor and unhealthy diets implicated with the increase of several non-
communicable diseases (NCDs) require a food-based approach to
reduce the ongoing rise.
• In the Indian scenario, the multitude of food products, including
medicinal type formats, such as health supplements, containing plant,
herbs or novel ingredients, brings in a new complexity to regulations.
• Several of these ingredients are pharmacologically active substances
and could overlap with drug regulations.

4. BEFORE DSHEA
• Prior to DSHEA of 1994, dietary supplements were subject to the same
requirements as other components of food under FFDCA (same
regulatory scrutiny as food additives)
• Burden of ensuring quality(within a Reasonable level of safety), safety,
accurate labeling & efficacy is placed upon the manufacturers (Contrast
scenario of FDA regulatory role with food additives & drugs)
• Now, It is the responsibility of FDA to prove that the supplement as
‘unsafe’ with sufficient data.

5. NHANES data for adults aged 20 and over were used to calculate the prevalence of
dietary supplement intake for three time periods (1988–1994, 1999–2002, and 2003–
2006) by demographic characteristics for five supplement categories: 1) any
supplement, 2) multivitamin/multi-mineral (contains at least three vitamins and may or
may not contain minerals), 3) supplement with folic acid, 4) supplement with vitamin D,
and 5) supplement with calcium, including antacids containing calcium.
NHANES - National Health & Nutrition Examination Survey

6. • The use of dietary supplements after introduction of DSHEA has
increased in a steady but slight way.
• The percentage of the U.S. population who used at least one dietary
supplement increased from 42% in 1988–1994 to 53% in 2003–2006
• Women were most likely to use one or more dietary supplements than
men for all three time periods.

7. Adequacy of nutrient intake: Intake of a nutrient that meets the individual's
requirement for that nutrient.

8. AIM OF DSHEA
 To ensure continued consumer access to a wide variety of dietary
supplements
 To provide consumers with more information about the intended use of
dietary supplements.
These had to accomplished without changing the fundamental regulatory status
of dietary supplements as a category of foods.

9. • The terms health supplements used in ASEAN countries or food
supplements in the EU countries and dietary supplements in the US are
all placed under food category 13.6 and have the same regulatory
meaning.
• The term 'nutraceuticals' while not recognized in international
regulations, to describe a similar food category, is an additional term in
the Indian regulations9.

10. The law provides FDA with appropriate regulatory authority and ample
enforcement tools to protect consumers while still allowing them the
desired access to a wide variety of affordable, high quality, safe and
beneficial dietary supplement products.

11. TERMS IN DSHEA
 DSHEA specifically reaffirmed the status of dietary supplements as a
category of food and created a specific definition for dietary supplements.
 DSHEA made it clear that ingredients of dietary supplements could not be
regulated as food additives. Instead, the legislation created two
categories of dietary supplement ingredients—“old” or “grandfathered”
ingredients and “new dietary ingredients.”
 DSHEA grandfathered all dietary supplement ingredients marketed in the
United States before October 15, 1994. These are considered safe for
continued consumer use.
 Before marketing a “new dietary ingredient” manufacturers must submit
a New Dietary Ingredient Notification to FDA to providing their basis for
judging that the ingredient “is reasonably expected to be safe.”

12. DSHEA
 Facts supporting the use of dietary supplements led to the inception
of DSHEA where a link was established between ingestion of certain
nutrients & prevention of chronic diseases like Cancer, Heart diseases
& Osteoporosis.
 Several chronic diseases can also be prevented by a healthful diet
consisting of but not limited to plant-based foods.

13. The term “dietary supplement” -
1) means a product (other than tobacco) intended to supplement the diet
that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the
total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any
ingredient described in clause (A), (B), (C), (D), or (E);

14. 2) means a product that -
(A)is intended for ingestion in a form described in USC section
411(c)(1)(B)(i) or USC section 411(c)(1)(B)(ii);
(B) is not represented for use as a conventional food or as a sole item of a
meal or the diet; and
(C) is labeled as a dietary supplement; and

15. (b) Exclusion from Definition of Food Additive.
Section 201(s) (21 U.S.C. 321(s)) was amended by excluding the dietary
supplements from food additives category & categorizing it separately
(c) Form of Ingestion.
Section 411(c)(1)(B) (21 U.S.C. 350(c)(1)(B)) was also amended.
(1) in clause (i), by inserting “powder, soft-gel, gel-cap,” after “capsule,”

16. Safety of Dietary Supplements and Burden of Proof on FDA.
Section 402 (21 U.S.C. 342) is amended by adding the following:
(f)(1) If it is a dietary supplement or contains a dietary ingredient that -
(A) presents a significant or unreasonable risk of illness or injury or
(B) Has inadequate information to provide reasonable assurance it is not
deemed as a dietary supplement

17. OTHER INCLUSIONS IN DSHEA
Misbranded Supplements
In Section 403 (21 U.S.C. 343) is amended by adding proper labelling
including the name of the ingredient, its quantity & the total mixture of
ingredients added.
Dietary Supplement labelling Exemptions for small volume business
Supplement Listing on Nutrition Labeling was made mandatory
Percentage Level Claims must be clearly mentioned
‘Vitamins and Minerals’ was replaced with ‘Dietary supplements’

18. Percentage of adults aged 20 & over who used any dietary supplement by sex and age
in the United states from 2017-2018

19. INFORMATION MANUFACTURER MUST
DISCLOSE ON THE LABEL OF A DIETARY
SUPPLEMENT
Information that must be on a dietary supplement label includes:
1) a descriptive name of the product stating that it is a "supplement;"
2) the name and place of business of the manufacturer, packer, or
distributor;
3) a complete list of ingredients
4) the net contents of the product &
5) Supplement Facts panel identifying each dietary ingredient
contained in the product.

20. COMMON LABEL CLAIMS MADE BY
FRAUDULENT MANUFACTURERS:
1) Decreases weight drastically
Eg. HCG
2) Drastic Physical enhancement
Eg. Improving physical endurance within 1 week of dosage.
3) Quick fix promises

21. HOW TO SUBMIT A NDIN
 Nowadays the claims are submitted through Center for Food Safety
and Applied Nutrition (CFSAN) CFSAN Online Submission
Module(COSM) of FIS
 It used to be submitted through the FDA Unified Registration and
Listing Systems or FURLS portal
 Provide the basis of evidence on which the supplement has been
found to have a reasonable level of safety.
 Wait for 75 days to market the drug

22. In 2016, over 57% respondents did not know what DSHEA was which may have been
the reason that the potential of dietary supplements & nutraceuticals is still widely
untapped.

23. Acknowledgement letter  Outcome statement
Only 1 in 4 NDI submissions get no objection

24. RECENT DEVELOPMENTS
In 2019, FDA commissioner Scott Gottlieb, MD, announced in a statement
that the organization wants to consider imposing tighter regulations.
Dr. Gottlieb pointed out that supplements have grown from a $4 billion to
$40 billion industry in the 25 years since the DSHEA was passed and, as
they've become more popular,
“so have the number of entities marketing potentially
dangerous products or making unproven or misleading
claims about the health benefits they may deliver.”
So the experts of this field in western countries prefer ‘Dietary Supplements’
instead of vague terms like ‘Nutraceuticals’ or ‘Functional foods’

25. • North America, Western and Eastern Europe is recording the highest
revenue shares in the dietary supplements market.
• The global market for dietary supplements is expected to witness
impressive CAGR of ~ 7.5% during 2015-2025, finds a recent study
published by Future Market Insights (FMI).
• The study estimates that, with a widening consumer base that is
shifting towards healthier dietary habits, the dietary supplements
market is estimated to surpass US$ 252 billion by 2025.

26. INSTANCES OF FDA RECALLS &
BANS
• Ephedra is a dietary supplement used
for weight loss FDA prohibited its sale in
the United States since April 12, 2004.
• CBD(Cannabidiol) accounts for 40% of cannabinoids in Cannabis plant
• N-Acetyl cysteine The FDA claims that there's no evidence that NAC
was used as a supplement prior to its use as a drug – so including
NAC in a supplement makes the product an unapproved drug and
thus illegal.

27. NUANCES
• Large volume Manufacturers sometimes don’t strictly adhere to the
safety standards which negatively affects the smaller volume
supplement manufacturers also.
Eg. Of other mass recalls
 Boots have recalled over 30 health products from sale due to the
presence of a substance banned from food in the EU.
 2-Chloroethanol – Banned ingredient in EU

28. CRITICISED FOR
• Being an industry-driven bill, the bill is made for the supplement
industry, a multibillion-dollar industry, and not for consumers
• Unlike drug products that must be proven safe and effective for their
intended use before marketing, there are no provisions in the law for
FDA to "approve" dietary supplements for safety or effectiveness
before they reach the consumer.
• Dietary supplements are regulated by the FDA as food, not as drugs.
• The public must be made aware of how potentially dangerous these
products can be.

29. CONCLUSION
 DSHEA was the product of a compromise with a lower threshold for
demonstration of safety (reasonable expectation of no harm) that
would be met by consumer self-policing and assumption of some risk.
 FDA has thwarted this effort by raising the bar for New Dietary
Ingredient Notifications (NDIN) to what appears to be the higher
threshold for the safety of food ingredients (reasonable certainty of
no harm)
 FDA sees no difference between these two safety thresholds & that
causes disputes between the manufacturers & FDA

30. REFERENCES
NCBI - Indian Journal of Medical Research
NIH - Office of Dietary Supplements
FD & C Act