"Traditional Use" and Regulatory Change in the Arena of Natural Health Products
Notice bibliographique
Résumé
Over the last three years, the federal government has been pressured to loosen advertising restrictions on Natural Health Products (NHPs). Such pressure has originated both externally (consumer petitions and the industry lobby) and internally (private member's bills). Government responded to this pressure by proposing new NHP regulations that would see these products exempted from the claim effected by s. 3 of the Food and Drugs Act (FDA). The health claim prohibition has functioned, in the past, to prevent NHP manufacturers from advertising their goods as treatments, cures or preventatives for a list of approximately 40 serious diseases / conditions set out in the FDA. With respect to diseases not covered by the health claim prohibition, NHP manufacturers have been allowed to advertise their goods as cures, treatments or preventatives provided that they could prove the safety and efficacy of the product with scientific data. The use has functioned as a regulatory loophole of sorts, allowing NHP manufacturers to advertise their goods as treatments, cures or preventatives for ailments excepted from the health claim prohibition, provided that they could demonstrate that the NHP has been traditionally as a treatment, cure or preventative for the ailment in question. The exception has been harshly criticized by groups such as the Centre for Science in the Public Interest because it has allowed NHP manufacturers to make health claims respecting NHPs even when the effectiveness of the product has been disproved scientifically. Moreover, Health Canada has proposed a regulatory amendment that will completely exempt NHPs from the health claim prohibition, thus expanding the scope of application attendant to the traditional use exception. This presentation discussed the legal nuances of the traditional use exception from a critical perspective, and advanced arguments opposing prospective regulatory changes that would provide NHP manufacturers greater leeway in advertising. These arguments were threefold. First, allowing health claims based only on traditional use is an invitation for charlatanry. Consumers rely on health claims when purchasing NHPs, and leaving them unregulated will result in economic exploitation. David Schardt has highlighted many ridiculous health claims in his article, Herbal Roulette: Does it work? Is it safe? Don't ask the government. (1) For example, Schardt notes that Echinacea has been shown in a number of scientific studies to be ineffective in the prevention of colds. Nonetheless, he asserts, Health Canada's Natural Health Products Directorate allows manufacturers to label Echinacea as being traditionally used to fight off colds, flus and infections. …
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,008 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».