Food Labelling, Standards and Consumer Protection Division

The National Association of Health Stores PO Box 1455, Sheffield, S7 2YD Tel/Fax 0114 249 5345 and 0114 236 3043 e-mail [email protected]

Rosemary Hignett Food Labelling, Standards and Consumer Protection Division Food Standards Agency PO Box 31037 Room 312 Ergon House 17 Smith Square London SW1P 3WG

23rd June 2000

Dear Mrs Hignett,

Draft Food Supplements Directive

Thank you for the opportunity to examine the official proposals for a Food Supplement Directive. Whilst we welcome many aspects of the proposals, there are some areas of concern that we respectfully bring to your attention within this letter.

Whilst the Directive is ‘safety-based’ at first sight, there are various elements which, when taken as a whole, could be used to stifle innovation and product development, and enhance the ability of the major manufacturers to dominate the market place.

We have listed our concerns with reference to how they appear in the draft directive.

Preamble

Section (6).

The scope of the directive is limited to approved vitamins and minerals, but may be expanded to cover other nutrients, including herbs. We understand and accept that it would be almost impossible to implement a directive in the first instance that would be all encompassing. However, we do wonder as to the status of nutrients that are currently excluded (e.g. choline, boron etc) and what their legal position will be once this directive becomes law.

Associate Members of the NAHS Absolute Aromas - Biocare - Bioforce - Brewhurst - Cambridge Probiotics - Country Life - Earth Force Enzsana - Franklin Publications - Granovita - Health & Diet - Health Food Business Magazine Health Imports - Herbal Health - Infinity Foods - Lanes - Linpharma - Nature’s Aid - Nature’s Own Nature’s Plus - Panda - Pharma Nord - Pharmadass - Premier Health Products - Salus - Solgar Specialist Herbal Supplies - Vega - Vitabiotics Moreover, what will be the status of a product that contains a mixture of approved and excluded nutrients? We believe that any safe products currently on sale within the EU should be allowed to remain on sale, if they are not specifically included within the scope of this directive.

Section (7).

Worryingly, this section states that if a vitamin or mineral is not part of the diet (whose diet?) and considered essential (by whom?) then it should not be allowed in a food supplement. If this concept is basic to the Directive, then it is difficult to see how this Directive could be expanded to encompass other nutrients.

The same sentence then appears to contradict itself by stating that the presence of the essential vitamin or mineral may not be necessary. If the vitamin or mineral is essential, then it follows that they must also be necessary.

This section is where the concept of positive listing is justified. A fundamental question that needs to be answered is whether a vitamin or mineral that is not on a positive list (e.g. sulphur) could remain on the market place as a NON food supplement?

This section also raises doubts over the future status of products currently on the market that are a mixture of ingredients on the positive lists, and ingredients that are not (e.g. cod liver oil with additional vitamin A and D).

Section (8).

This section contains the justification for the positive listing of chemical forms of nutrient. We have the same concerns with this section as with Section (7). The attached annex of permitted chemical forms is woefully inadequate, and would have tremendous impact on our industry and consumer choice.

We would urge the government to collate data from the natural products industry regarding the totality of safe chemical forms currently in use. These should be added to the annex.

Section (9).

We are pleased to see that the Commission accepts that revision of the positive lists should be prompt. However, there is no indication as to the mechanism, other than it will be internal to the Commission. We do not believe that this is appropriate.

There is also no indication of timescale – we would suggest that a timescale is incorporated, perhaps no longer than 90 days?

Section (10).

We are pleased to see the concept of maximum safe levels in this section, but would prefer the term ‘upper safe levels’ (USL’s), as this is a scientific term with accepted meaning.

At the moment the Ad Hoc Expert Group is considering this area within the UK, and the Scientific Committee for Foods is considering this area on behalf of the EU. What will be the UK Government position if the two bodies come up with different recommendations?

2 Section (11).

This section is worrying because having accepted USL’s from an unidentified source; the Commission will then set maximum safe levels for food supplements.

As USL’s take into account the totality of food/supplement intake, and are set to protect the most vulnerable sectors of the population, there is no need to set another safe level. We believe that the USL’s developed by science should be adopted by the Commission without further manipulation.

Section (12) & (13).

There is no need to set minimum levels. This precedent would stifle innovation and product development, especially if and when the Directive is expanded to cover non-vitamin and mineral ingredients.

Absorption from supplements is acknowledged to be poor – one reason for higher dosage. If industry developed a method of enhancing absorption so that the desirable dose from a supplement would actually be under the minimum level set within the directive, then perfectly safe and desirable products would be denied to the consumer.

We already market co-enzyme forms of vitamins that can be taken in a lower dose compared to the more conventional form. If this technology develops further, as it is almost bound to do, then the setting of minimum levels would deny the consumer access to superior quality products.

There are also circumstances in which a manufacturer would only want to place a very small amount of a specific nutrient into a product as a co-factor for either absorption, or synergism.

Most importantly, science cannot establish the minimum levels at which nutrients have physiological activity. Even if science could establish such minimum levels of physiological activity, would this not require consideration of directive 65/65/EEC?

There are many products on the market (e.g. colloidal minerals and sublingual sprays) that would be removed by the setting of minimum levels, unless they are set at incredibly low and therefore irrelevant amounts.

Directive

Article 1.

Section 1 This section appears to limit the scope of the whole Directive to pre-packed products. Could the legislation be circumvented by selling VMS products loose, as many shops continue to do? We believe that this would be a retrograde step. We would ask that products sold loose be specifically mentioned as within the remit of this legislation.

3 Article 2.

Section (b) Annex 1 omits many nutrients that are accepted to be part of traditional vitamin complexes, such as PABA and inositol, whilst choline can be considered a vitamin in certain circumstances.

Annex 2 omits many safe and legitimate minerals, such as boron, silicon and vanadium, which have been on the market for many years.

Section (c) This section does not allow the sale of sublingual sprays that are currently on the market. Are they to become illegal, or are they also outside of the legislation?

Article 2 is not clear about the future of combinations of ingredients that are within and without this Directive (e.g. a multi-vitamin that includes approved vitamins and minerals together with silicon, bioflavanoids, etc)

Article 3.

Article 3 is also confusing as to the future of products not contained within this directive, if they are blended with nutrients listed in Article 2(b).

Article 4.

What will be the legal status of products that remain outside of this directive? As an example, will silicon become illegal?

Article 5.

Section 1 This is an explanation of why the Commission considers it necessary to set independent maximum safe levels for supplements. We believe this to be false justification in that

a) Upper safe levels set by reputable scientific bodies already account for intakes of vitamins and minerals from other dietary sources. There is no need to consider this twice. b) Population reference intakes are irrelevant to the consideration of upper safe levels of a nutrient. They relate to the minimum perceived intake necessary to avoid deficiency disease, and have no bearing whatsoever on the question of toxicity.

Section 2 This section justifies the setting of minimum amounts of a nutrient. As mentioned before, not only is this scientifically unjustifiable, but serves no useful purpose whatsoever.

Article 6.

Section 1 This mandates that the name of all products will include either ‘Vitamin Supplement’ or ‘Mineral Supplement’, unless individual nutrients are involved, where they could be called ‘Vitamin C Supplement’ as an example.

4 Presumably ‘VM75’ or ‘Super-Once-a-Day’ (if allowed to remain on the market in their present form) will become,

‘VM75 Vitamin & Mineral Supplement’, and ‘Super-Once-a-Day Vitamin & Mineral Supplement’.

This seems to be completely unnecessary, as these products carry full disclosure labelling, including what they are – but not as part of the name.

Section 2 Does this section mean that we will be able to include structural and functional claims? Under the EU concept of positive lists, as we are not specifically excluded from such claims, they should be permissible.

Section 3 What does ‘...portion of the product...’ mean? Without knowing what is being referred to, it is difficult to comment.

We believe that a statement on all products that ‘...food supplements should not be used as a substitute for a diversified diet.’ could potentially harm consumers. For example, it would be difficult, if not impossible, for a pregnant woman to obtain currently recommended levels of folates from food alone.

Whilst not directly relevant to the EU, the Keshan province of China distributes selenium tablets to the population in order to avoid heart disease, and many areas of the world iodize table salt to avoid pandemic levels of goitre. It is quite clear that a diversified diet is not always good enough.

Section 4 This section states that if the form of presentation of a product is similar to a pharmaceutical form as defined by pharmacopœias, then the label shall carry the statement ‘This is not a medicinal product’.

Given the wide variation in presentation of pharmaceutical products, virtually all food supplements will have to carry such a statement, and we wonder as to the wisdom of this instruction.

Article 7

This appears to be a simple repetition of Article 6, Section 3(c). Why is this necessary?

Article 8

Section 1 This refers to Annex 1, which needs amendment. Vitamin B6 has always been referred to in milligrams (mg), and needless confusion will result if this is changed to micrograms (mcg, or μg)

Section 2 This is confusing terminology. Whose recommendation for daily consumption is to be on the label? Whatever this means, what purpose would this information serve, when the consumer is able to see the amount of ingredient per tablet/capsule etc (Article 8, Section 1) along with the percentage comparison to the PRI’s (Article 8, Section 3).

This Section is not only confusing, but appears to be irrelevant.

5 Article 12

This appears to allow countries to restrict a product for internal reasons against the spirit of this Directive. We believe that this Article should be specific regarding the circumstances in which ‘safety concerns’ can be used by a Member State. As the Commission will be thoroughly examining safety data as part of formulating this directive, it is difficult to envisage circumstances where it might be necessary for a Member State to take unilateral action.

We have commented briefly on Annexes 1,2 and 3. These are our more detailed comments on what we consider to be unnecessarily restrictive, and scientifically untenable positive lists.

Annex 1

Vitamins

As vitamin E is only referred to in terms of α-tocopherol, what about the β, γ and δ tocopherols and other forms of vitamin E such as tocotrienols? Are they to become illegal? If so, what is the rationale?

Vitamin B6 has always been referred to in milligrams (mg), and needless confusion will result if this is changed to micrograms (mcg, or μg).

Whilst Annex 1 is not incomplete under the very strictest interpretation of a vitamin (organic substance needed in small amounts that cannot be synthesized by the body and is essential for life), there are many nutrients missing from this list that have been traditionally accepted as vitamins; choline, inositol, para-amino-benzoic acid (PABA), orotic acid (B13), pangamic acid (B15), bioflavanoids (Vitamin P), and lipoic acid.

One has to question why these nutrients are missing, and what their status on the marketplace will be if they remain outside of the Annex.

If the interpretation of the term ‘vitamin’ is to be strict, the inclusion of vitamin K is puzzling, as vitamin K is synthesized by bacteria in the gut and is therefore not a true vitamin. Moreover, vitamins D, B12, choline, lipoic acid, PABA and inositol can also considered not to be true vitamins, as these can also be synthesized in the body.

There is no consistency within Annex 1.

Minerals

Without knowing the criteria for inclusion within this list, it is difficult to comment on why certain minerals are missing. One criterion cannot be necessity for life, as Sulphur is omitted, along with silicon and cobalt.

Other minerals thought to be essential are omitted, such as vanadium, tin, nickel, boron, arsenic and cadmium.

Whilst we do not advocate the inclusion of all of these minerals into the Annex, we do feel that the criteria for inclusion needs to be consistent, as with Annex 1.

6 As the human body is known to contain nearly all the elements of the periodic table, it seems likely that other substances will be ‘discovered’ as essential for life as science in this area progresses.

Will they be added to the Annex? If science determines upper safe levels for supplementation, should they be omitted from the Annex?

Annex 2

Vitamins

There are many serious omissions of chemical forms of vitamins and minerals that are currently on the market, have been on the market for a considerable period of time, and are known to be safe.

A simple example has been mentioned above; only the α-tocopherol form of vitamin E is included. What of the β, γ, δ and other forms of vitamin E, such as tocotrienols?

Only two forms of chromium are to be allowed - chloride and sulphate. What of the polynicotinate, picolinate or even simple yeast?

Three forms of selenium are allowed, with the omission of selenomethionine, amino-acid chelate and simple yeast, amongst others.

The same restrictions apply to virtually all other vitamins and minerals, including calcium, magnesium, iron and zinc.

There needs to be a compilation of data from the manufacturers of all the different forms of vitamins and minerals currently in use (or in development?) so that this Annex can be extended. Otherwise, this Annex will decimate the UK industry, and reduce the quality and choice of product available to the consumer.

From a purely practical viewpoint, negative lists make more sense from an industry and consumer perspective, whereas positive lists achieve only one objective – the restriction of choice.

General Comments

The directive, as currently drafted, appears to be a very real threat to the continued presence on the market of products that are not catered for within its provisions. It is comparable to the recent PARNUT’s directive, upon which we believe these positive lists to be based, since it appears that if a particular nutrient (or form of nutrient) is not specified as permitted within the directive, then that item’s use would be unlawful.

The difference is that the PARNUT’s Directive is specific as to those types of product it applies to. The Food Supplements Directive defines what a food supplement is, but does not specify what impact the legislation will have on products that fall outside of that specific remit.

7 It appears that this directive would make it unlawful to market a product that contains a blend of permitted ingredients together with ingredients that do not appear within an Annex. This measure alone would have serious implications for the UK natural products industry, and precipitate the removal, or reformulation, of a significant number of products.

We sincerely hope that Government will share our concerns, and that the continued viability of the UK natural products industry is not going to be compromised by these flaws in an otherwise well intentioned piece of legislation.

We hope that these brief comments will be of some interest to you, and we look forward to your response. If we can be of any assistance please do not hesitate to contact the NAHS Office.

With best wishes and kind regards,

Ralph A Pike Association Director