Presentación de Josef Brinckman (ITC)

8/3/2019 Presentacin de Josef Brinckman (ITC)

1/25

The U.S. Market

for Natural Products

Foro Perunatura 2011

By: Kerry Hughes and Josef BrinckmannITC Consultants

Date: 29 September 2011


2/25

ITC Market Brief 2011

This presentation is based on a 2011 ITC study entitled:

THE NORTH AMERICAN MARKET FOR NATURAL PRODUCTS withHighlights on Selected Andean and African Products

The study is a revision and update of a 2003 ITC study entitled:

THE UNITED STATES MARKET FOR NATURAL INGREDIENTS USED

IN DIETARY SUPPLEMENTS AND COSMETICS with Highlights onSelected Andean Products

2


3/25

Market Overview Key Trends for 2012

Continuing acceptance of exotic foods and flavors

Dietary supplements appear to be recession proof especially

those that have proven to be effective for age-relatedconditions

Omega-3 essential fatty acids fish and vegetable sources

Functional foods and beverages including so-called superfoods, super fruits, and beauty foods

3


4/25

Market Overview Key Trends for 2012

Natural products free of undesirable components: antibiotic-and hormone-free, gluten-free, GMO-free, high-fructose-corn-syrup-free

Natural sweeteners - agave nectar, due to its low-glycemicappeal; extracts of stevia leaf and of super fruits

Sustainability brands: organic, fairtrade and local

Truly natural cosmetics

4


5/25

Market OverviewProduct Types

Dietary Supplements / Herbal Supplements

Regulated as a subset of food products. FDA Notification required within 30-days of marketing. Substantiation file required to support claim statements.Eligible for certain Authorized Health Claims, Qualified Health Claims, NutrientContent Claims, and/or Structure / Function Claims. Supplement Facts box..

Foods with Health Claims / Functional FoodsRegulated as food products; marketed as Functional Foods or Super Foods.Some may be eligible for certain Authorized Health Claims, Qualified HealthClaims, and/or Nutrient Content Claims. Nutrition Facts box.

Botanical Drugs (OTC and Rx)Includes both conventional botanical drug (e.g. Capsicum Oleoresin) and herbalhomoeopathic drug products. Sold in natural food stores and pharmacies.Eligible for Disease Claims and/or Structure / Function Claims. Drug Facts box.

5


6/25


Natural Cosmetics & Body Care

Includes non-drug cosmetics and drug cosmetics.

Non-drug cosmetic products are eligible for Cleansing, Beautifying and PromotingAttractiveness claims.

If disease claims are made (Cocoa Butter for temporary relief of hemorrhoidaldiscomfort), then it is a drug cosmetic labeled according to FDA monograph withDrug Facts box.

Natural Pet Foods

Regulated similar to other animal feeds-no premarket approval needed.

6


7/25


7


8/25

One Botanical Ingredient

Can Have Different Market ChannelsIt is possible that a single botanical (processed in different forms) couldfind several different avenues into the U.S. market.

For example flaxseed oil (a.k.a. linseed oil)(fatty oil from ripe seeds ofLinum usitatissimum), could be used in most market channels (includingas a component of dietary supplements, functional foods, pet foods, andcosmetics & body care products).

8


9/25

One Botanical Ingredient

Can Have Different Market ChannelsPeru is a producer and exporter of Organic and Fair Trade CertifiedCocoa Butter (fat obtained from the seed of Theobroma cacao), which,in the U.S., is permissible for use as a component of:

food products (e.g. in chocolate bars or ice cream);

dietary supplement products (e.g. in energy bars or protein bars);

non-drug cosmetic products (e.g. in skin moisturizing creams andlotions); and

OTC botanical drug products (e.g. as an active ingredient ofhemorrhoidal drug products and/or as an active ingredient of lip or skinprotectant drug products).

9


10/25

Market Access what about new ingredients?

Dietary Supplement if the substance was not in U.S. commerce priorto 15 October 1994, a New Dietary Ingredient (NDI) submission to FDAis necessary.

Drug if the substance is not already classified by FDA as GenerallyRecognized as Safe and Effective (GRASE), a New Drug Application(NDA) would be necessary.

Food if the substance is not already classified by FDA as Generally

Recognized As Safe (GRAS), it needs to be affirmed as GRAS for itsspecific intended use as a food.

10


11/25

Market Access Quality and Safety

GACPs (Good Agricultural & Collection Practices) not legislativelymandated but buyers may inspect and qualify harvest sites accordingto a specific GACP Standard.

GMPs (Good Manufacturing Practices) GMP compliance ismandatory with different sets of GMPs for different types of products(e.g. cosmetic GMPs, dietary supplement GMPs, food GMPs orhomoeopathic drug GMPs).

11


12/25

Market Access Quality and Safety

Bioterrorism Act of 2002 requires registration of foreign facilitiesand prior notice to FDA of imports into the U.S.

FDA Food Safety Modernization Act (FSMA) of 2011

1. requires U.S. importers to perform supplier verification activities toensure imported food is safe;

2. authorizes FDA to refuse admission to imported food if the foreignfacility or country refuses to allow an FDA inspection;

3. authorizes FDA to require certification, based on risk criteria, thatthe imported food is in compliance with food safety requirements;

4. provides an incentive for importers to take additional food safety

measures by directing FDA to establish a voluntary program throughwhich imports may receive expedited review of their shipments if theimporter has taken certain measures to assure the safety of the food.

12


13/25

Market Access - Quality Requirements

Supplier Qualifications Under GMP rules, buyers can purchase only fromqualified suppliers. The importers Quality Control (QC) Unit is responsiblefor qualifying suppliers. Under FSMA, the importer must perform supplierverification activities.

Specifications Under GMP rules, specifications are required to testidentity, composition, quality and purity. Dietary supplement and foodproduct ingredients can have food-grade specifications. Pharmacopoeial qualitystandards are voluntary for dietary supplements but mandatory forbotanical drug products.

Monographs There are FCC and NF monographs available for foodquality standards and USP monographs for both dietary supplement andbotanical drug quality specifications.

13


14/25

Market Access - Emerging Ecological andSocial Certifications / Labels

Fair Trade (including FLO Fairtrade, FWF FairWild, and IMO Fair forLife Fair Trade Certified)

Organic (NOP or Demeter)

Rainforest Alliance

Whole Trade Guarantee (Whole Foods Market)

14


15/25

Packaging and Labeling: what aboutbilingual labels?

Product label text must be in English except in the Commonwealth ofPuerto Rico where the labeling may be presented in Spanish language(or in bilingual labeling) or in other U.S. territories where the predominantlanguage is one other than English.

Bilingual labels are permitted in the U.S. market so long as all of therequired elements are provided in both languages (e.g. in bothEnglish and Spanish).

15


16/25

Example of Acceptable BilingualNutrition Facts Labeling

16


17/25

Distribution Channels - Successful models forforeign natural ingredient suppliers in the US market

Difficult to succeed in the US market without maintaining a strongpresence inside the US, including sales, marketing, warehousing,technical support, etc.

Without own warehousing or sales/marketing operation, still possibleto succeed through strategic relationships with well-positioned UScompany. For example, by partnering with a well-established Americancompany to distribute and market your brand of natural products to the

US market. This could occur under your brand, or co-branded or underyour US partners established brand.

17

18


18/25

Sales Promotion natural ingredients

Supply Side West

Las Vegas, NV

10-11 October 2011

engredea Ingredients & Innovation

Anaheim, CA

9-11 March 2012

18

19


19/25

Sales Promotion finished products

Natural Products Expo West

Anaheim, CA

9-11 March 2012

Natural Products Association Marketplace

Las Vegas, NV

15-16 June 2012

19

20


20/25

Market prospects for exportersIdentified by Market Brief 2011

1. Stable prospect for herbal medicines/dietary supplements

Growth has now slowed considerably market maturation, and

increase in regulations and enforcement.

Dietary supplements in the US have proven to be recession-proof, asthe older baby boomer generation have favored them as a way to stayhealthy compared to prescription drugs and preventable medical

procedures particularly true for supplements that have been found tobe effective for specific gender- and age-related conditions

20

21


21/25


2. Growing Prospect for Super Foods

Super foods are particularly popular among the younger generations

(those 18-29 in the US) Group with a some discretionary income

Remained the most optimistic about the future of the economythroughout the recession

More likely than other generations to say they like to try out new foods

and drinks

21

22


22/25


3. Growing prospect for interesting oils

Top sellers in the US and Canadian market is DHA and other omega-3

fatty acids

Among the Peruvian natural products, sacha inchi is showing the mostpotential in this area, however, issues around source, stability andpricing have not yet been well established it may be possible to

reposition sacha inchi oil with a qualified health claim if the productcan be shown to meet the specified omega-3 fatty acids contentrequirements for the allowed label claim.

22

23


23/25


4. Growing prospect for sustainable & ethnical

Certifications, such as Fair Trade, combined with organic

High area of market growth (especially for Fair Trade coffee, chocolate,cosmetic (cocoa butter), ice cream, spice and tea brands).

Fair Trade (& other Social Certifications) also provide opportunities forproducers, guarantees of higher prices or premiums in the market,

along with good working conditions for farmers or farm workers in thesupply chain and long-term relationship building with caring buyers inthe U.S.

23

24


24/25

Peruvian / Latin American Botanicalswith High Interest

Camu Camu a juice, super food, functional food and dietary supplement (for itsVitamin C content, antioxidants, and anti-inflammatory properties), and perhaps incosmetics (the seed oil or fruit pulp extract), or as a natural color or flavor

Cupuau juice, super food, functional food and dietary supplement (for itsantioxidants), and perhaps in cosmetics (the fruit pulp extract), or as a natural flavor

Lucuma juice, super food (for its nutritive content, including fiber, vitamins andminerals), functional food and dietary supplement (for its antioxidants), and perhaps incosmetics (the fruit pulp extract), or as a natural flavor

Sacha Inchi super food (as the nut), functional food and dietary supplement (for itsomega-3 fatty acid content), and perhaps in cosmetics (the oil)

Maca super food (as a powder), functional food (in various potential forms), and willcontinue to have a market for its dietary supplement use

Chiasuper food (as the seeds or oil), functional food and dietary supplement (for itsomega-3 fatty acid content), and perhaps in cosmetics (the oil)

24

25


25/25

Key Concluding Thoughts

There is still high interest, opportunity and growth in the NorthAmerican natural products market.

However, it is no longer enough to merely be a supplier of a

natural ingredient or finished product. Stricter scrutiny byconsumers and government demand compliance with newsafety requirements, stronger evidence to support claimedbenefits, as well as sustainability and eco-socialexpectations.

To reach the market effectively will require suppliers to score wellin all of these areas; safe and effective / natural andsustainable.

25

Presentación de Josef Brinckman (ITC)

Documents

Transcript of Presentación de Josef Brinckman (ITC)